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.

Clear
DateProductReasonClassFirm
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catal... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 7, 2023 Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARAC... Custom surgical procedure packs contain latex gloves but are labeled as "latex free". Class II Alcon Research, LLC
Aug 31, 2023 smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, ... The firm conducting a recall due to a complaint received indicating that a package contained a LE... Class II Smith & Nephew Inc
Aug 31, 2023 Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP Endobronchial implant devices may have been labeled with a shortened expiration date but they can... Class II Pulmonx, Corp.
Aug 29, 2023 Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quan... Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual ki... Class II CooperSurgical, Inc.
Aug 25, 2023 Detector H. Pylori, Catalog Number IHP-30 Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the ... Class II Immunostics, Inc.
Aug 24, 2023 Various Medical Products stored on pallets, including but not limited to band... Various medical devices potentially exposed to rodent and rodent activity. In addition, medical d... Class II Inmar Supply Chain Solutions, LLC
Aug 22, 2023 Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implan... Class II Covidien LP
Aug 22, 2023 Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P... The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) b... Class II Smiths Medical ASD Inc.
Aug 18, 2023 Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC866... The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the pro... Class II North Coast Medical Inc
Aug 3, 2023 3T Heater Cooler System, REF: 16-02-85 The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance sch... Class II LivaNova Deutschland GmbH
Jul 31, 2023 Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, De... The incorrect product labeling was applied to the product indicating the wrong size of product. Class II Medtronic Sofamor Danek USA Inc
Jul 31, 2023 Perifix¿ / Epidural anesthesia set, medicated Product may be mislabeled with an incorrect lid stock label. Class II B. Braun Medical, Inc.
Jul 27, 2023 Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M00310142... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M00310143... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M00310146... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M00310162... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M00310144... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M00310148... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M00310147... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 27, 2023 Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M00310163... Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear t... Class II Boston Scientific Corporation
Jul 26, 2023 M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item N... The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, a... Class II Zimmer, Inc.
Jul 25, 2023 ZVU Functional GI Software, REF: ZVU-3 GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. Class III Diversatek Healthcare
Jul 24, 2023 TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71... A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL... Class II Smith & Nephew, Inc.
Jul 24, 2023 TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71... A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL... Class II Smith & Nephew, Inc.
Jul 21, 2023 Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide ... A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish ... Class II Keystone Industries
Jul 20, 2023 Visera Hysterovideoscope Olympus HYF Type V IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brus... Class II Olympus Corporation of the Americas
Jul 18, 2023 PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflectin... Class II Smiths Medical ASD Inc.
Jul 14, 2023 MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Ins... Product is labeled with incorrect offset. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 7, 2023 procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 2... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 2... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 50-GEL20; Ultrasound gel Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 ASG-001; Ultrasound gel Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, 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.