Drug & Device Safety Atlas

FDA recall record · openFDA

B BRAUN MEDICAL INC

241 FDA recalls on record (2023–2026) — 22 drug,219 device. 235 still ongoing.

19
Class I (most serious)
221
Class II
1
Class III
235
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inabili 116
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV cont 29
Potential for the lid of the catheter connector to be in the incorrect position. 13
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloods 9
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that 8

Recalls

Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0 Class I 2026-04-28 Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), B Class I 2026-05-06 B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L. Class I 2026-03-19 Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867 Class I 2026-05-06 B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A. Class I 2026-03-19 B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA. Class I 2026-03-19 B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705. Class I 2026-03-19 B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705. Class I 2026-03-19 B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096 Class I 2026-03-19 Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C Class I 2026-05-06 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, ND Class I 2025-08-18 Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC Class I 2025-08-18 Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing. Class I 2025-07-09 Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M20 Class I 2025-09-30 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-0 Class I 2024-07-24 Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U Class I 2024-08-07 Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 3 Class I 2023-11-01 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System Class I 2023-09-21 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System Class I 2023-09-21 DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: Class II 2026-04-02 LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: Class II 2026-04-02 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, Class II 2026-04-02 Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 1801 Class II 2026-04-02 Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: Class II 2026-01-29 Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software V Class II 2026-01-29 Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product De Class II 2026-02-02 Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Softwa Class II 2026-01-29 Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Class II 2026-01-29 Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: Class II 2026-01-29 Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Class II 2026-02-02 Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version Class II 2026-02-02 Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 So Class II 2026-01-29 Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Ve Class II 2026-01-29 Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Class II 2026-01-29 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose containe Class II 2025-08-04 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem Class II 2025-08-26 STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60. Class II 2025-08-26 Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, Class II 2025-08-04 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Bra Class II 2025-03-31 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx onl Class II 2025-06-16 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In Class II 2025-10-29 SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Class II 2025-10-29 Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space L Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged a Class II 2025-09-18 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In Class II 2025-10-29 Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space L Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. Class II 2025-09-18 Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x Class II 2025-09-18 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar Class II 2025-10-29 Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La Class II 2025-10-29 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged an Class II 2025-09-18 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La Class II 2025-10-29 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In Class II 2025-10-29 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Class II 2025-10-29 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Class II 2025-10-29 SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spac Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN Class II 2025-09-18 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and Class II 2025-09-18 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD J Class II 2025-09-18 PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1 Class II 2025-09-18 Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. Class II 2025-09-18 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Class II 2025-10-29 Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Class II 2025-10-29 PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1 Class II 2025-09-18 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Class II 2025-10-29 Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter. Class II 2025-02-17 PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Class II 2025-09-18 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 CARESAFE utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space La Class II 2025-10-29 Burette Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Class II 2025-10-29 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged a Class II 2025-09-18 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In Class II 2025-10-29 SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Lar Class II 2025-10-29 Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Class II 2025-10-29 PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PER Class II 2025-09-18 Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus Class II 2025-10-29 Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Class II 2025-10-29 Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Class II 2024-03-06 Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7 Class II 2024-03-22 OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administra Class II 2024-06-17 Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a Class II 2024-06-17 Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) adm Class II 2024-06-17 Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of device Class II 2024-01-22 SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemod Class II 2024-08-15 Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) Class II 2024-06-17 Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) Class II 2024-06-17 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Softwar Class II 2024-06-14 Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administratio Class II 2024-06-17 Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) Class II 2024-06-17 Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administrati Class II 2024-06-17 Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a Class II 2024-06-17 Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) Class II 2024-06-17 Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) Class II 2024-06-17 STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodi Class II 2024-08-15 STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodi Class II 2024-08-15 STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during hae Class II 2024-08-15 Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251. Class II 2024-05-17 STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model Class II 2024-08-15 Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) adm Class II 2024-06-17 Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description Class II 2024-06-14 Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) ad Class II 2024-06-17 Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: P Class II 2024-06-14 Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) admini Class II 2024-06-17 OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration o Class II 2024-06-17 Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a Class II 2024-06-17 Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) Class II 2024-06-17 Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Class II 2024-01-22 Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV Class II 2024-06-17 Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) ad Class II 2024-06-17 Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administ Class II 2024-06-17 Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260 Class II 2024-05-17 Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) Class II 2024-06-17 Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) adm Class II 2024-06-17 Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) Class II 2024-06-17 Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administra Class II 2024-06-17 Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) a Class II 2024-06-17 STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during Class II 2024-08-15 Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) a Class II 2024-06-17 OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration o Class II 2024-06-17 Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal Class II 2024-12-04 Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product D Class II 2024-06-14 AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number Class II 2024-08-08 Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) Class II 2024-06-17 Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) admin Class II 2024-06-17 STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during Class II 2024-08-15 Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502 Class II 2024-05-17 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Pro Class II 2024-06-14 Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278 Class II 2024-05-17 Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.B Class II 2023-03-01 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, ND Class II 2023-02-10 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, N Class II 2023-02-10 Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Class II 2023-05-09 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-352 Class II 2023-07-05 Design Options¿ / Epidural anesthesia kit (10 count carton) Class II 2023-06-05 Perifix¿ / Epidural anesthesia set, medicated Class II 2023-07-31 B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metere Class II 2023-08-07 TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set. Class II 2023-09-26 THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium- Class II 2023-09-26 B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dos Class II 2023-08-07 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system. Class II 2023-09-26 AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use. Class II 2023-09-26 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system. Class II 2023-09-26 ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. Class II 2023-09-26 FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution conta Class II 2023-09-26 SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use. Class II 2023-09-26 Perifix¿ / Epidural anesthesia kit (10 count carton) Class II 2023-06-05 BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component. Class II 2023-09-26 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, ND Class III 2023-08-02

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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