Browse Device Recalls

3,367 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,367 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 3,367 FDA device recalls in IL.

Clear
DateProductReasonClassFirm
Dec 22, 2022 MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008 The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill b... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 22, 2022 MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013 The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill b... Class II MEDLINE INDUSTRIES, LP - Northfield
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Heal... 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 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by... 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 McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by ... 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-2188 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, 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, 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, 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-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, 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, 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-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, 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, 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, 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 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, 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, 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, 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, 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, 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-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, 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, 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, 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, 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, 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 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, 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, 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, 32 Fr, REF JP-2292 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 9, 2022 Alinity m System. The Alinity m System is designed to automate the steps... The firm identified the following three potential issues which may have impacted ADUs installed o... Class II Abbott Molecular, Inc.
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRA... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield

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.