Browse Device Recalls

26 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 26 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 26 FDA device recalls.

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DateProductReasonClassFirm
Dec 24, 2025 Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tournique... Device user interface (screen) may freeze or become unresponsive to touch when operating in certa... Class II Zimmer Surgical Inc
Dec 24, 2025 Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tournique... Device user interface (screen) may freeze or become unresponsive to touch when operating in certa... Class II Zimmer Surgical Inc
Nov 24, 2025 Zimmer Dermatome AN, Model/Catalog Number: 88710100 The devices may have a misaligned thickness control bar. Class II Zimmer Surgical Inc
Nov 24, 2025 Zimmer Air Dermatome, Model/Catalog Number: 00880100100 The devices may have a misaligned thickness control bar. Class II Zimmer Surgical Inc
Jan 2, 2024 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1... Class II Zimmer Surgical Inc
Sep 5, 2023 Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the d... Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at... Class II Zimmer Surgical Inc
Jan 3, 2020 Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, D... When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to... Class II Zimmer Surgical Inc
Apr 16, 2019 Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alva... Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II B... Class II Zimmer Surgical Inc
Jun 8, 2018 Zimmer Dermatone AN, Model No. 88710100 Devices may have a loose control bar, which could compromise the ability to control the thickness... Class II Zimmer Surgical Inc
Jul 27, 2017 A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be u... Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3... Class II Zimmer Surgical Inc
Jul 27, 2017 A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, In... Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device... Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . ... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width pla... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimme... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width pla... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Wid... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. T... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jul 4, 2016 Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate i... The surface coating applied to the device is blistering, peeling and discoloring after usage over... Class II Zimmer Surgical Inc
Jun 24, 2015 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, ... The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions a... Class II Zimmer Surgical Inc
Jun 24, 2015 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer S... The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions a... Class II Zimmer Surgical Inc
Apr 21, 2015 Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer... Devices were placed in a shipper carton without the appropriate number of the Instructions for Us... Class III Zimmer Surgical Inc
Oct 6, 2014 UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric hand... Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece ... Class II Zimmer Surgical Inc
May 7, 2013 Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-ste... This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air ... Class II Zimmer Surgical Inc
May 7, 2013 The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafti... This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air ... Class II Zimmer Surgical Inc
May 7, 2013 Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile gr... This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air ... Class II Zimmer Surgical 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.