Is your drug or device recalled?
A source-backed catalog of 12,421 FDA drug and device recalls. Every record traces to openFDA enforcement data, published by the U.S. Food & Drug Administration. A recall is a recorded enforcement action — it does not mean any specific unit harmed anyone. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device. Most recalls are Class II or III.
What the recall classes mean
Reasonable probability of serious harm or death.
Temporary or medically reversible harm, with a remote chance of serious harm.
Unlikely to cause harm.
Search recalls
Type a product name, brand, drug, device, or recalling firm. Filters the list below — open any recall for its lot and code details so you can tell whether your unit is the one recalled.
Showing 120 of 12,421 recalls (most serious first) — type to search all 12,421.
- Class IUDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPhaMcKesson · Drugs · 2026-01-16
- Class IGas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPCHaleon US Holdings LLC · Drugs · 2026-06-04
- Class IMagnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bagsAmneal Pharmaceuticals, LLC · Drugs · 2026-03-18
- Class ILactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0B BRAUN MEDICAL INC · Drugs · 2026-04-28
- Class IMG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: PharWisconsin Pharmacal Company · Drugs · 2026-04-24
- Class IWebcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, WaCardinal Health 200, LLC · Drugs · 2026-03-02
- Class IDOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, ManufactureSUN PHARMACEUTICAL INDUSTRIES INC · Drugs · 2026-05-12
- Class IBD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (Becton Dickinson & Company · Devices · 2026-04-27
- Class IMedline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNMedline Industries, LP · Devices · 2026-03-24
- Class IBoston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VABoston Scientific Corporation · Devices · 2026-03-19
- Class IOmnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7Insulet Corporation · Devices · 2026-03-12
- Class ISpinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), BB Braun Medical Inc · Devices · 2026-05-06
- Class IPhilips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.Philips Respironics, Inc. · Devices · 2026-03-02
- Class IAtlan A350XL. Model Number: 8621600. anesthesia workstationDraeger, Inc. · Devices · 2026-05-07
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class IPhilips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.Philips Respironics, Inc. · Devices · 2026-03-02
- Class IHalyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.AVID Medical, Inc. · Devices · 2026-03-13
- Class IImpella RP Flex with SmartAssist. Product Code: 1000323.Abiomed, Inc. · Devices · 2026-01-27
- Class INAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007;Medline Industries, LP · Devices · 2026-02-27
- Class IFlexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical useErbe USA Inc · Devices · 2026-02-12
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline KitMedline Industries, LP · Devices · 2026-04-10
- Class IOwner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. DescriptiTrividia Health, Inc. · Devices · 2026-02-06
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class IBD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8Becton Dickinson & Company · Devices · 2026-04-27
- Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, MedlMedline Industries, LP · Devices · 2026-04-10
- Class IRolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGOmnicell, Inc. · Devices · 2026-03-25
- Class IImpella RP with SmartAssist. Product Code: 0046-0035.Abiomed, Inc. · Devices · 2026-01-27
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class IConvenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK MoAmerican Contract Systems Inc · Devices · 2026-03-19
- Class IOwner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. DescriptionTrividia Health, Inc. · Devices · 2026-02-06
- Class ICentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31KMerit Medical Systems, Inc. · Devices · 2026-02-13
- Class INamic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducerMedline Industries, LP · Devices · 2026-03-24
- Class IFlexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical useErbe USA Inc · Devices · 2026-02-12
- Class IBD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (Becton Dickinson & Company · Devices · 2026-04-27
- Class IMedline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981CMedline Industries, LP · Devices · 2026-03-24
- Class IVOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000Ventec Life Systems, Inc. · Devices · 2026-03-25
- Class IProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C,Merit Medical Systems, Inc. · Devices · 2026-02-13
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class INAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10MMedline Industries, LP · Devices · 2026-02-27
- Class IImpella RP. Product Code: 0046-0011.Abiomed, Inc. · Devices · 2026-01-27
- Class IHalyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.AVID Medical, Inc. · Devices · 2026-03-13
- Class IAutomated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella ControllerAbiomed, Inc. · Devices · 2026-02-16
- Class ICustom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA SWindstone Medical Packaging, Inc. · Devices · 2026-04-02
- Class IPediatric care bed; Product Designation: KayserBett IDA;KAYSERBETTEN GMBH & CO. KG · Devices · 2026-05-04
- Class IOlympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatOlympus Corporation of the Americas · Devices · 2026-01-16
- Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BMedline Industries, LP · Devices · 2026-04-10
- Class IPhilips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.Philips Respironics, Inc. · Devices · 2026-03-02
- Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF,Medline Industries, LP · Devices · 2026-04-10
- Class IArrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-151ARROW INTERNATIONAL, LLC · Devices · 2026-04-10
- Class IBoston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled asBoston Scientific Corporation · Devices · 2026-03-19
- Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINMedline Industries, LP · Devices · 2026-04-10
- Class IArrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-IARROW INTERNATIONAL, LLC · Devices · 2026-04-10
- Class INextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-ARROW INTERNATIONAL, LLC · Devices · 2026-04-10
- Class IHalyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.AVID Medical, Inc. · Devices · 2026-03-13
- Class IOlympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automaOlympus Corporation of the Americas · Devices · 2026-01-16
- Class IHalyard CATH LAB kit. Model Number: SACL75-01.AVID Medical, Inc. · Devices · 2026-03-13
- Class IPurge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configuratAbiomed, Inc. · Devices · 2026-02-18
- Class IB. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.B Braun Medical Inc · Devices · 2026-03-19
- Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, MedlineMedline Industries, LP · Devices · 2026-04-10
- Class IMedline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/Medline Industries, LP · Devices · 2026-03-24
- Class I16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/BMerit Medical Systems, Inc. · Devices · 2026-02-13
- Class INAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/Medline Industries, LP · Devices · 2026-02-27
- Class IHalyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.AVID Medical, Inc. · Devices · 2026-03-13
- Class IOwner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. DescriptionTrividia Health, Inc. · Devices · 2026-02-06
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class ICannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-152ARROW INTERNATIONAL, LLC · Devices · 2026-04-10
- Class IRelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-Bolton Medical Inc. · Devices · 2026-04-22
- Class IBioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96Merit Medical Systems, Inc. · Devices · 2026-02-13
- Class IAIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kitsNorth American Rescue LLC. · Devices · 2026-03-27
- Class IHandy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., LtdNavajo Manufacturing Company · Devices · 2026-02-18
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class IMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SMedline Industries, LP · Devices · 2026-04-10
- Class IHalyard CATH LAB kit. Model Number: SACL75AM.AVID Medical, Inc. · Devices · 2026-03-13
- Class IPhilips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.Philips Respironics, Inc. · Devices · 2026-03-02
- Class I1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEAMedline Industries, LP · Devices · 2026-03-24
- Class IPhilips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.Philips Respironics, Inc. · Devices · 2026-03-02
- Class IBD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (Becton Dickinson & Company · Devices · 2026-04-27
- Class IBD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8Becton Dickinson & Company · Devices · 2026-04-27
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class IHalyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.AVID Medical, Inc. · Devices · 2026-03-13
- Class IHalyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.AVID Medical, Inc. · Devices · 2026-03-13
- Class ISpinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867B Braun Medical Inc · Devices · 2026-05-06
- Class IBD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivBecton Dickinson & Company · Devices · 2026-04-27
- Class I1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MMedline Industries, LP · Devices · 2026-03-24
- Class IBD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0.75%) with dextrose (Becton Dickinson & Company · Devices · 2026-04-27
- Class IDuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H7871030Merit Medical Systems, Inc. · Devices · 2026-02-13
- Class IBD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8Becton Dickinson & Company · Devices · 2026-04-27
- Class IOlympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automaticOlympus Corporation of the Americas · Devices · 2026-01-16
- Class IBlue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara RespiratoryBaxter Healthcare Corporation · Devices · 2026-02-18
- Class IPhilips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.Philips Respironics, Inc. · Devices · 2026-03-02
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class IOwner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. DescriptioTrividia Health, Inc. · Devices · 2026-02-06
- Class IB. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.B Braun Medical Inc · Devices · 2026-03-19
- Class IHalyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.AVID Medical, Inc. · Devices · 2026-03-13
- Class INamic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, maniMedline Industries, LP · Devices · 2026-03-24
- Class IB. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.B Braun Medical Inc · Devices · 2026-03-19
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class IBD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (Becton Dickinson & Company · Devices · 2026-04-27
- Class IMedical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/CaseMedical Action Industries, Inc. 306 · Devices · 2026-03-17
- Class INamic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, maniMedline Industries, LP · Devices · 2026-03-24
- Class IAtlan A350. Model Number: 8211500. anesthesia workstationDraeger, Inc. · Devices · 2026-05-07
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class IPhilips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.Philips Respironics, Inc. · Devices · 2026-03-02
- Class IBD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (Becton Dickinson & Company · Devices · 2026-04-27
- Class INAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/Medline Industries, LP · Devices · 2026-02-27
- Class IB Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.B Braun Medical Inc · Devices · 2026-03-19
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class IB. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.B Braun Medical Inc · Devices · 2026-03-19
- Class ILVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.Fresenius Kabi USA, LLC · Devices · 2026-05-06
- Class IHalyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.AVID Medical, Inc. · Devices · 2026-03-13
- Class INamic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, maniMedline Industries, LP · Devices · 2026-03-24
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class IAutomated Impella Controller (AIC); Product Code: 0042-0000-US;Abiomed, Inc. · Devices · 2026-04-20
- Class IFlexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical useErbe USA Inc · Devices · 2026-02-12
- Class INamic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure transducerMedline Industries, LP · Devices · 2026-03-24
- Class IIvenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004Fresenius Kabi USA, LLC · Devices · 2026-05-06
- Class IMedline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringeMedline Industries, LP · Devices · 2026-02-27
- Class ICentimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic proceduresCook Incorporated · Devices · 2026-04-02
- Class IIntuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Intuitive Surgical, Inc. · Devices · 2026-03-11
Machine-readable orientation for agents: /llms.txt ·
every recall serves .jsonld and .json.
Methodology & sources