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
Jul 29, 2022 Hobbs Posi-Stop Injection Needle Catalog Number: 4712 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Catalog Number: 6566 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6028 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Transbronchial Aspiration Needle Catalog Number: 4621 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Posi-Stop Injection Needle Catalog Number: 4722 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Grasping Forceps Catalog Number:5004 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Cytology Brush Catalog Number: 4204 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Catalog Number: 6533 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Helical Retrieval Basket Catalog Number: 4822 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Cytology Brush Catalog Number: 4206 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Catalog Number: 6567 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Helical Retrieval Basket Catalog Number: 4808 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endo... Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Catalog Number: 6562 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Helical Retrieval Basket Catalog Number: 4816 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Posi-Stop Injection Needle Catalog Number: 4704 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Grasping Forceps Catalog Number: 5008 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Helical Retrieval Basket Catalog Number: 4832 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Catalog Number: 6584 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Helical Retrieval Basket Catalog Number: 4806 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Posi-Stop Injection Needle Catalog Number: 4718 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For en... Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Posi-Stop Injection Needle Catalog Number: 4702 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Catalog Number: 6548 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Catalog Number: 6544 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Helical Retrieval Basket Catalog Number: 4824 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Catalog Number: 6568 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent Catalog Number: 6582 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541 Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 29, 2022 Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Cat... Device label display an incorrect expiration date, extends the shelf life of the product. Affecte... Class II Hobbs Medical, Inc.
Jul 27, 2022 Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00... An incorrect sizing label was applied to the carton packaging. Class II Wright Medical Technology, Inc.
Jul 27, 2022 ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP,... In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. Class II GELITA MEDICAL GMBH
Jul 27, 2022 Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Nu... installation issues Class II BARCO NV
Jul 27, 2022 Diasol Acid Concentrate REF G100325-10Dex 100 Due to labeling issue. The box label is different that the gallon label in that gallon label sho... Class II Diasol, Inc
Jul 27, 2022 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute a... (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, ha... Class II Fresenius Medical Care Holdings, Inc.
Jul 26, 2022 ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking age... Class II Abbott Laboratories
Jul 26, 2022 Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Co... Acidified Concentrate Distribution System potential electrical safety hazard may result in electr... Class II Isopure Corp

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.