Browse Device Recalls

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

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DateProductReasonClassFirm
Dec 15, 2022 HIGH V+ Spinal Cement System REF T040321K Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration d... Class II TEKNIMED SAS
Dec 15, 2022 Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative d... Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that ... Class II Meridian Bioscience Inc
Dec 15, 2022 Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care T... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 PICC KIT, 10/CS, ACCESS MEDICAL LABEL Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy ... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vi... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosp... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Pac... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 AxiEM" Non-Invasive Patient Tracker Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints an... Class II Medtronic Navigation, Inc.
Dec 15, 2022 Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to repla... Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than th... Class II Biomet, Inc.
Dec 15, 2022 BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy o... The affected product may contain a medium other than the Biopsy Medium. There is a risk that use... Class II CooperSurgical, Inc.
Dec 15, 2022 Henry Shein GLOVES, packaged in the following sizes and descriptions: a. G... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufacture... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein. Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs P... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Tech... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per ba... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and ca... Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 GORE CARDIOFORM Septal Occluder, REF: GSX0030A Septal Occluders released with incomplete quality test documentation that assesses the release of... Class II W L Gore & Associates, Inc.
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215 Cardinal Health recently received multiple complaints regarding various performance issues with C... 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
Dec 13, 2022 SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-... Class II Olympus Corporation of the Americas

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.