Browse Device Recalls

275 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 275 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 275 FDA device recalls.

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DateProductReasonClassFirm
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
Sep 20, 2023 Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject 20 mL Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 20, 2023 Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack Demonstrated recognition and compatibility issues with syringe infusion pumps. Class I Cardinal Health 200, LLC
Sep 13, 2023 Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Pr... Syringe contains conical tip that is not compatible with certain needleless IV connector(s). Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Fr... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Steri... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexne... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile. Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MH... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) ... XXX Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced S... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Aug 16, 2023 Procedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C... Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT... Class II Cardinal Health 200, LLC
Jun 16, 2023 NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V1146... Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regard... Class II Cardinal Health 200, LLC
Apr 6, 2023 Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for... Inadvertently released for distibution without sterility assurance. Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II 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.