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Browse Device Recalls

80 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 80 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 80 FDA device recalls.

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DateProductReasonClassFirm
Jul 21, 2017 MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-P... It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity... Class II Stryker Medical Division of Stryker Corporation
Mar 29, 2017 Medi-Therm Hyper/Hypothermia System, MTA7900 The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to... Class II Stryker Medical Division of Stryker Corporation
Nov 8, 2016 Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to com... Class II Stryker Medical Division of Stryker Corporation
May 5, 2016 Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Powe... Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either t... Class II Stryker Medical Division of Stryker Corporation
Feb 5, 2016 Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) we... Class II Stryker Medical Division of Stryker Corporation
Feb 5, 2016 Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stret... The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) we... Class II Stryker Medical Division of Stryker Corporation
Feb 2, 2016 S3 MedSurg Bed, Model 3005. Stryker Medical CPU board failures cause fowler (backrest) electronic controls to stop working. Class II Stryker Medical Division of Stryker Corporation
Dec 3, 2015 Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressur... Potential for power cord to melt; hazards include electric shock and fire. Class II Stryker Medical Division of Stryker Corporation
Oct 13, 2015 Two-stage and three-stage I.V. poles are shipped as an optional accessory to ... It was identified by a customer complaint that some I.V. poles were retracting/lowering from an ... Class II Stryker Medical Division of Stryker Corporation
Jul 2, 2015 Spirit One A-C Powered Hospital Bed Inaccurate scale systems Class II Stryker Medical Division of Stryker Corporation
Jul 2, 2015 Spirit One A-C Powered Hospital Bed Customer complaints associated with faulty brake system Class II Stryker Medical Division of Stryker Corporation
Jun 4, 2014 InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, ... Stryker has received complaints from the field alleging instances where the In Touch beds are hoi... Class II Stryker Medical Division of Stryker Corporation
Dec 27, 2013 The Gaymar Medi-Therm device provides a means of regulating patient temperatu... Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water tem... Class II Stryker Medical Division of Stryker Corporation
Nov 26, 2013 S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in ... Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds b... Class II Stryker Medical Division of Stryker Corporation
Nov 26, 2013 Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically fo... Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds b... Class II Stryker Medical Division of Stryker Corporation
Oct 23, 2013 Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term car... It was reported that the siderail may appear latched when it is not, due to lack of proper preven... Class II Stryker Medical Division of Stryker Corporation
Aug 19, 2013 The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in el... The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the openi... Class II Stryker Medical Division of Stryker Corporation
Jul 12, 2013 IsoGel AIR 84, Support Surface. Intended to assist in improving human pati... Complaints were received from the field indicating that some Air Pumps were flashing and alarming... Class II Stryker Medical Division of Stryker Corporation
Dec 18, 2012 Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg B... Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2... Class II Stryker Medical Division of Stryker Corporation
Dec 18, 2012 Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg ... Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2... Class II Stryker Medical Division of Stryker Corporation
Oct 11, 2012 The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system de... Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have be... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both ... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 Go Bed II+ Model FL28C Beds are intended for medical purposes in both gen... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in ... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in ... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 GoBed+ . Model FL20E Beds are intended for medical purposes in both genera... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation

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.