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Browse Device Recalls

73 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 73 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 73 FDA device recalls.

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DateProductReasonClassFirm
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 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: 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
Jun 3, 2022 Hobbs Medical Polypectomy Snare, Catalog No. 7202 During use, the sheath of the device may accordion at the proximal end where the sheath meets the... Class II Hobbs Medical, Inc.
Dec 28, 2021 Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial samplin... The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. ... Class II Hobbs Medical, Inc.
May 1, 2018 Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be util... Device was marketed for uses outside the 510(k) clearance. Class II Hobbs Medical, Inc.

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.