Browse Device Recalls

5,540 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,540 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 5,540 FDA device recalls.

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DateProductReasonClassFirm
May 4, 2026 MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTER... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, M... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/S... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medl... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Me... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Num... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCO... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL,... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Numb... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Me... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, A... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Ki... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
May 4, 2026 MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Ki... During an internal review, Medline identified representative samples did not meet applicable perf... Class II Medline Industries, LP
Apr 30, 2026 directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number... Assayed Whole blood control contains labeling with incorrect performance range. Class II Accriva Diagnostics, Inc.
Apr 29, 2026 Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm A... The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mah... Class II Mozarc Medical US LLC
Apr 24, 2026 HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual pack... Class II Devicor Medical Products Inc
Apr 23, 2026 Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 108845... Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) p... Class II Covidien LLC
Apr 23, 2026 Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Micr... 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives. Class II SSC- Surgical Specialties Corporation
Apr 22, 2026 RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N... Labeling update concerning proximal clasp disconnection from the outer control tube which may pre... Class I Bolton Medical Inc.
Apr 15, 2026 COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI ... Due to customer complaint regarding incorrect display box labeling. Class II Covidien LLC
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ2... Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, ... Class II Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 10, 2026 Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... Class I Medline Industries, LP
Apr 3, 2026 TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 4... Due to incorrect functional length on device labeling. Class II Grace Medical, Inc.
Mar 27, 2026 Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO Labeling update to provide warning if functionality of the valve replacement delivery system is ... Class II Edwards Lifesciences, LLC
Mar 27, 2026 AIDBAGs are first aid kits of convenience composed of individually labeled de... Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has b... Class I North American Rescue LLC.
Mar 25, 2026 Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number ... Potential for mislabeled syringe produced by the i.v.STATION device. Class I Omnicell, Inc.
Mar 24, 2026 Hintermann Series Talar Implant, Left, Size 2 REF 302112 Through customer complaints, the ankle replacement system was found to contain incorrect devices:... Class II DT MedTech, LLC
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, ... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: TAV... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 24, 2026 Medline medical convenience kits, containing Namic Manifold, Labeled as: HEA... Medline has identified the presence of particulate within the fluid path of the Manifolds. Class I Medline Industries, LP
Mar 20, 2026 Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cer... Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5... Class II Centinel Spine, Inc.
Mar 20, 2026 Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical di... Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5... Class II Centinel Spine, Inc.
Mar 19, 2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... Class II Medline Industries, LP
Mar 19, 2026 Centurion medical procedure kits, containing Medline Neuro Sponges, labeled a... During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... Class II Medline Industries, LP
Mar 19, 2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... Class II Medline Industries, LP
Mar 19, 2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... Class II Medline Industries, LP
Mar 19, 2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... Class II Medline Industries, LP
Mar 19, 2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... Class II Medline Industries, LP
Mar 19, 2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... Class II Medline Industries, LP
Mar 19, 2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... Class II Medline Industries, LP
Mar 19, 2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... Class II Medline Industries, LP
Mar 19, 2026 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... Class II Medline Industries, LP

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.