Browse Device Recalls
302 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 302 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 302 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number:... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHI... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog N... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog N... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Nu... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Numb... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET09... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11F... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFH... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPB... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog N... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 1, 2024 | Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT61... | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure speci... | Class II | Cardinal Health 200, LLC |
| Nov 1, 2024 | Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back,... | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure speci... | Class II | Cardinal Health 200, LLC |
| Sep 25, 2024 | Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 118... | Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with... | Class I | Cardinal Health 200, LLC |
| Jul 24, 2024 | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 4... | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... | Class II | Cardinal Health 200, LLC |
| Jul 24, 2024 | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve,... | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... | Class II | Cardinal Health 200, LLC |
| May 29, 2024 | Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number S... | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... | Class II | Cardinal Health 200, LLC |
| May 29, 2024 | Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Cata... | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... | Class II | Cardinal Health 200, LLC |
| May 29, 2024 | Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number ... | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... | Class II | Cardinal Health 200, LLC |
| May 29, 2024 | Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Cata... | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... | Class II | Cardinal Health 200, LLC |
| Apr 17, 2024 | CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9... | Potential contamination of the product with latex adhesive residual. | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF ... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475 | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF ... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF S... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF S... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Rese... | Class II | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection S... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit C... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, R... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For U... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777 | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit ... | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have r... | Class I | Cardinal Health 200, LLC |
| Dec 28, 2023 | Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection S... | Cardinal Health is expanding their previous product correction actions to a product removal of al... | Class I | Cardinal Health 200, LLC |
| Dec 21, 2023 | Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Caniste... | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... | Class II | Cardinal Health 200, LLC |
| Dec 21, 2023 | Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Caniste... | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... | Class II | Cardinal Health 200, LLC |
| Dec 21, 2023 | CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510 | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience ... | Class II | Cardinal Health 200, LLC |
| Dec 4, 2023 | Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DR... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Dec 4, 2023 | Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE,... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
| Dec 4, 2023 | Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0... | Convenience kits were manufactured and distributed with components which were subsequently recall... | Class I | Cardinal Health 200, LLC |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.