Stryker Medical Division recalls
Stryker Medical Division appears in 80 official U.S. recall notices indexed by RecallRadar, most recently on 2026-03-25.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 80 |
|---|---|
| Published | 2012-07-04 to 2026-03-25 |
| By agency | FDA Device (80) |
| By classification | Class II (79), Class III (1) |
| By status | terminated (42), ongoing (38) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Cub Pediatric Crib, Model FL19H
FDA Device · Class II · 2026-03-25 · Stryker Medical Division
Reason: Cribs sold in the USA are missing two access door warning labels. - Stryker MV3 bariatric bed, Part Number 5900000001
FDA Device · Class II · 2025-12-17 · Stryker Medical Division
Reason: Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These p… - Stryker Arise 1000EX mattress, Part Number 2236000000
FDA Device · Class II · 2025-12-17 · Stryker Medical Division
Reason: Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These p… - ProCuity bed series, model number 3009, item number: 3009PX-L-100
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCuity bed series, model number 3009, item number: 3009PX-ZM-600
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCuity bed series, model number 3009, item number: 3009PX-L-200
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCuity bed series, model number 3009, item number: 3009PX-ZM-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCuity bed series, model number 3009, item number: 3009PX-LEX-400
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCurity bed series, model number 3009, item number: 3009PX-ZX-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCuity bed series, model number 3009, item number: 300900000000
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCuity bed series, model number 3009, item number: 3009PX-LEX-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCuity bed series, model number 3009, item number: 3009PX-LE-400
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCuity bed series, model number 3009, item number: 3009PX-LE-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - ProCuity bed series, model number 3009, item number: 3009PX-Z-450
FDA Device · Class II · 2023-12-13 · Stryker Medical Division
Reason: Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock. - Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is d…
FDA Device · Class II · 2023-07-19 · Stryker Medical Division
Reason: Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty raising or lowering the cot, cot tip, or erratic or unintended motion. - Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location
FDA Device · Class II · 2023-03-22 · Stryker Medical Division
Reason: Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement… - Power-PRO 2, Model No. 6507, Item No. 650705550001 (US)
FDA Device · Class II · 2022-12-21 · Stryker Medical Division
Reason: Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected. - Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, P…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2,…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recove…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 28500…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pe…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002,…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended f…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Numb…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setti…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Number…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710,…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division
Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but… - Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the pati…
FDA Device · Class II · 2020-10-07 · Stryker Medical Division
Reason: Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients experiencing cardiac arrest and needing CPR - Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to suppor…
FDA Device · Class II · 2020-05-20 · Stryker Medical Division
Reason: Ambulance Cots may not meet crash test standard BS EN 1789 - Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
FDA Device · Class II · 2019-05-22 · Stryker Medical Division
Reason: The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. - Naera Hospital Bassinet, Model No. 4402
FDA Device · Class II · 2019-02-13 · Stryker Medical Division
Reason: It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Eval… - The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Device · Class II · 2018-11-21 · Stryker Medical Division
Reason: The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment. - The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Device · Class II · 2018-11-21 · Stryker Medical Division
Reason: The beds with the high rail side rail option may not be complaint with IEC 60601-2-52/C1:2010. There is a potential risk of entrapment. - Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature control…
FDA Device · Class II · 2018-10-31 · Stryker Medical Division
Reason: Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5¿C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relati… - IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of…
FDA Device · Class II · 2018-09-26 · Stryker Medical Division
Reason: Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier. - 6381 M-1 Cot Fastener, catalog no. 6381000000
FDA Device · Class II · 2018-05-09 · Stryker Medical Division
Reason: The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. - 6376 M-1 Cot Fastener, catalog no. 6376000000
FDA Device · Class II · 2018-05-09 · Stryker Medical Division
Reason: The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. - Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and…
FDA Device · Class II · 2018-04-25 · Stryker Medical Division
Reason: The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. - T/Pump temperature therapy pump, Models TP700 and TP700C
FDA Device · Class III · 2018-03-21 · Stryker Medical Division
Reason: The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement.