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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
Jun 29, 2016 TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intende... Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati... Class II Winco Mfg., LLC
Jun 29, 2016 TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended u... Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati... Class II Winco Mfg., LLC
Jun 29, 2016 TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Ch... Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specificati... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncol... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, ... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Cli... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital ... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Pat... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialy... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital ... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Onco... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco XL Convalescent Recliner - with Steel Casters Long term patient reclin... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis,... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis,... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Apr 2, 2015 Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Reco... Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... Class II Winco Mfg., LLC
Sep 6, 2013 DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms... A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ... Class II Winco Mfg., LLC
Sep 6, 2013 CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholste... A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ... Class II Winco Mfg., LLC
Sep 6, 2013 XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold... A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ... Class II Winco Mfg., LLC
Sep 6, 2013 PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table option... A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this produ... Class II Winco Mfg., LLC
Sep 24, 2012 PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 20... The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... Class II Winco Mfg., LLC
Sep 24, 2012 Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN ... The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... Class II Winco Mfg., LLC
Sep 24, 2012 Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01,... The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... Class II Winco Mfg., LLC
Sep 24, 2012 PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2... The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 1... Class II Winco Mfg., LLC
Jul 10, 2012 Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 344... Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The rec... Class II Winco Mfg., LLC
Jul 10, 2012 Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***... Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The rec... Class II Winco Mfg., LLC

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.