Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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 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 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 | 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 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 | 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: 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 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: 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 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. |
| 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 | 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 | Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B... | Product not registered for use in the UK | Class III | Microbiologics Inc |
| Jul 22, 2022 | Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEM... | One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix ... | Class II | Corin Ltd |
| Jul 18, 2022 | BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Dr... | Incorrect expiration date listed on the product labels. The expiration date listed on the product... | Class II | Becton Dickinson & Company |
| Jul 13, 2022 | ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number S... | MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case ... | Class II | Materialise USA LLC |
| Jun 29, 2022 | Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 29, 2022 | Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 29, 2022 | Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5... | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 29, 2022 | Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708 | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains... | Class II | Trinity Sterile, Inc. |
| Jun 28, 2022 | BIOPHEN UFH Control Plasma | Incorrect product labeling was included in the package. | Class III | Aniara Diagnostica LLC |
| Jun 27, 2022 | (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. ... | The product was mispackaged (swapped). The devices within the inner tray matches the inner tray ... | Class II | Smith & Nephew, Inc. |
| Jun 24, 2022 | ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 | An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5... | Class III | Zeiss, Carl Inc |
| Jun 20, 2022 | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, H... | Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Tra... | Class II | NuVasive Inc |
| Jun 14, 2022 | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative co... | The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm co... | Class III | R & D Systems, Inc. |
| Jun 10, 2022 | Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Ca... | Between March 2, 2021 and December 31, 2021, the product label used in production did not contain... | Class III | Invacare Corporation |
| Jun 6, 2022 | Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ068909... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE M... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, ... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
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.