Browse Device Recalls
79 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 79 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 79 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 31, 2025 | Stryker MV3 bariatric bed, Part Number 5900000001 | Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because som... | Class II | Stryker Medical Division of Stryker Corporation |
| Oct 31, 2025 | Stryker Arise 1000EX mattress, Part Number 2236000000 | Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because som... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-L-200 | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 300900000000, | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-ZM-600. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-LEX-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-Z-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-LE-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCurity bed series, model number 3009, item number: 3009PX-ZX-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-LEX-400. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-ZM-450. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-L-100. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 30, 2023 | ProCuity bed series, model number 3009, item number: 3009PX-LE-400. | Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... | Class II | Stryker Medical Division of Stryker Corporation |
| May 24, 2023 | Power-PRO 2- A powered ambulance cot that consists of a platform, including a... | Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficult... | Class II | Stryker Medical Division of Stryker Corporation |
| Feb 1, 2023 | Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from ... | Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and fo... | Class II | Stryker Medical Division of Stryker Corporation |
| Nov 11, 2022 | Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (Intern... | Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury ... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Prime TC-transport chair intended for medical purposes to assist a person in... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Isolibrium Support Surface - support surface assists in the prevention and tr... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | TruRize Clinical Chair - support structure that places human occupants in upr... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four buil... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Surgistool-intended to support a healthcare professional during surgical proc... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | IsoGel Air - support surface assists in the prevention and treatment of all p... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Symmetry Plus Treatment Recliner - general hospital use as a convenient seati... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | ComfortGel - assists in the prevention and treatment of all pressure injury s... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Stretcher Chair-for use in all acute care hospitals and medical outpatient se... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | CUB Pediatric Crib- intended to provide a pediatric patient support surface f... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Transport Stretcher 747 - a non-powered, wheeled device designed to support p... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | S3 MedSurg Bed - intended to support and transport patients within the Med/Su... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | InTouch 2131-intended to support a human patient in an acute care setting, M... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Michael Graves with Stryker Highback Chair-intended for pediatric and adult p... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | S3 MedSurg Bed - intended to support and transport patients within the Med/Su... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Proform- support surface is used to assist in the prevention and treatment of... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and sh... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 12, 2020 | Stryker IsoAir 2.0 support surface-provides pressure redistribution and is in... | Connector between support surface and pump may be out of tolerance resulting in difficulty in rem... | Class II | Stryker Medical Division of Stryker Corporation |
| Apr 7, 2020 | Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product... | Ambulance Cots may not meet crash test standard BS EN 1789 | Class II | Stryker Medical Division of Stryker Corporation |
| Nov 20, 2018 | Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000 | The power load floor plates which hold the ambulance cot anchors in place during patient transpor... | Class II | Stryker Medical Division of Stryker Corporation |
| Oct 10, 2018 | Naera Hospital Bassinet, Model No. 4402 | It was identified that the volume of air inside the mattress may expand in regions of high altitu... | Class II | Stryker Medical Division of Stryker Corporation |
| Oct 8, 2018 | The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option | The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. T... | Class II | Stryker Medical Division of Stryker Corporation |
| Oct 8, 2018 | The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option | The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. T... | Class II | Stryker Medical Division of Stryker Corporation |
| Sep 6, 2018 | Altrix¿ Precision Temperature Management System Model: 8001Product Usage: T... | Users may experience alarm fatigue due to frequent alarming relating to patient temperature devia... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 13, 2018 | IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The Is... | Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier. | Class II | Stryker Medical Division of Stryker Corporation |
| Mar 12, 2018 | Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 076... | The power load floor plates which hold the ambulance cot anchors in place during patient transpor... | Class II | Stryker Medical Division of Stryker Corporation |
| Mar 9, 2018 | 6376 M-1 Cot Fastener, catalog no. 6376000000 | The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect i... | Class II | Stryker Medical Division of Stryker Corporation |
| Mar 9, 2018 | 6381 M-1 Cot Fastener, catalog no. 6381000000 | The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect i... | Class II | Stryker Medical Division of Stryker Corporation |
| Nov 7, 2017 | T/Pump temperature therapy pump, Models TP700 and TP700C | The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence,... | Class III | Stryker Medical Division of Stryker Corporation |
| 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 |
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.