Browse Device Recalls

441 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 441 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 441 FDA device recalls.

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DateProductReasonClassFirm
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
Aug 16, 2024 Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Sa... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Sa... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health S... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
Aug 16, 2024 Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Sal... Due to convenience kits containing a kit component that is under a recall action for improper use. Class II Windstone Medical Packaging, Inc.
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
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wi... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catal... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Ca... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wirele... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
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
Dec 4, 2023 Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC,... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRA... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, ... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC... Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 TRACH KIT W/HYDROGEN & SALI Convenience kits were manufactured and distributed with components which were subsequently recall... Class I Cardinal Health 200, LLC
Dec 4, 2023 Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PRO... 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.