FDA recall record · openFDA
Smiths Medical ASD Inc.
130 FDA recalls on record (2023–2025) — 130 device. 130 still ongoing.
61
Class I (most serious)
69
Class II
0
Class III
130
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
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tra 28
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitori 24
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufactu 12
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devic 9
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due 9
Recalls
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FO Class I 2025-04-10 smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24 Class I 2025-02-13 CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0 Class I 2025-04-10 smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1. Class I 2025-02-13 CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA Class I 2025-04-10 smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O. Class I 2025-02-13 CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111 Class I 2025-04-10 smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8F Class I 2025-02-13 smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O. Class I 2025-02-13 CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Class I 2025-04-10 Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 Class I 2025-02-13 smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer Class I 2025-02-13 smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24 Class I 2025-02-13 smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Class I 2025-02-13 smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., R Class I 2025-02-13 smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, Class I 2025-02-13 smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., RE Class I 2025-02-13 smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6F Class I 2025-02-13 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Produ Class I 2024-05-29 CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following u Class I 2024-02-27 a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDI Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH N Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Class I 2024-05-29 smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS Class I 2024-02-07 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/L Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Class I 2024-05-29 CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD S Class I 2024-07-16 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT Class I 2024-05-29 Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX Class I 2024-05-31 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Pro Class I 2024-05-29 smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS Class I 2024-02-07 smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Class I 2024-06-07 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N Class I 2024-05-29 smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as foll Class I 2024-06-07 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Pro Class I 2024-05-29 smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as foll Class I 2024-06-07 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/L Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/Li Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List N Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Num Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Class I 2024-05-29 paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N Class I 2024-05-31 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Produ Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Cod Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List N Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANG Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Cod Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/Li Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List N Class I 2024-05-29 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Cod Class I 2024-05-29 CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: I Class I 2024-02-27 paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N Class I 2024-05-31 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANG Class I 2024-05-29 CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, Class I 2024-02-27 Pneupac paraPAC plus 300 ventilator kit, REF P300NXX Class I 2024-05-31 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO S Class I 2024-05-29 smiths medical Medfusion Model 3500 Syringe pump Class I 2023-12-19 smiths medical Medfusion Model 4000 syringe pump Class I 2023-12-19 CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100 Class II 2025-02-14 CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 Class II 2025-02-14 medex Arterial Kit 1/EA, Product Code REF MX7827 Class II 2024-09-24 smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714 Class II 2024-09-24 medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT Class II 2024-09-24 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP Class II 2024-06-26 smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000 Class II 2024-07-18 medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242 Class II 2024-09-24 smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) Class II 2024-07-18 ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 Class II 2024-06-26 smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP Class II 2024-10-28 CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Class II 2024-06-26 medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1 Class II 2024-09-24 medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT Class II 2024-09-24 smiths medical portex, Y' PIECE 15MM, REF 100/276/000 Class II 2024-07-18 smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS Class II 2024-07-18 medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547 Class II 2024-09-24 ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28 Class II 2024-06-26 smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CA Class II 2024-06-26 medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545 Class II 2024-09-24 smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76 Class II 2024-10-28 medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T Class II 2024-09-24 smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP Class II 2024-10-28 medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260 Class II 2024-09-24 medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548 Class II 2024-09-24 medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC Class II 2024-09-24 medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T Class II 2024-09-24 medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T Class II 2024-09-24 medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1 Class II 2024-09-24 CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 Class II 2024-06-26 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 Class II 2024-06-26 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 Class II 2024-06-26 medex TranStar Single ICP Set 1/EA, Product Code REF MX20897 Class II 2024-09-24 medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2 Class II 2024-09-24 medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T Class II 2024-09-24 medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T Class II 2024-09-24 CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 Class II 2024-06-26 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP Class II 2024-06-26 medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740 Class II 2024-09-24 medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086 Class II 2024-09-24 medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543 Class II 2024-09-24 medex TranStar Disposable Transducer 1/EA, Product Code REF MX950 Class II 2024-09-24 smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/15 Class II 2024-07-18 medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544 Class II 2024-09-24 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R Class II 2023-11-10 Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R Class II 2023-11-10 Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-5 Class II 2023-12-19 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL Class II 2023-11-10 Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 Class II 2023-12-19 DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port f Class II 2023-04-05 Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1 Class II 2023-09-06 Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 Class II 2023-08-16 Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 06 Class II 2023-08-16 Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile. Class II 2023-08-22 HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP Class II 2023-11-10 Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0 Class II 2023-08-16 Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 Class II 2023-08-16 Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0 Class II 2023-12-19 DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Po Class II 2023-04-05 HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP Class II 2023-11-10 6IN PRESSURE TUBING, List Number MX20617 Class II 2023-11-10 Medex LOGICAL CATH LAB KIT, List Number M20754 Class II 2023-11-10 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR Class II 2023-11-10 Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump Class II 2023-08-16 Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 301 Class II 2023-12-19 DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elb Class II 2023-04-05 Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R Class II 2023-11-10 Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump Class II 2023-08-16 PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter Class II 2023-07-18
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.