Portage, MI, United States
Stryker Medical Division of Stryker Corporation recalls
18 recalls recorded since 2018, most recently on 18 February 2026. 7 are listed as ongoing. Status and classification are as published by the FDA.
Recalls18
Ongoing (FDA)7
Terminated or completed11
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 February 2026
- Reason
- Cribs sold in the USA are missing two access door warning labels.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1580-2026
- Cub Pediatric Crib, Model FL19H
Ongoing Class II Medical devices
- Recall started
- 31 October 2025
- 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 products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.
- Distribution
- US, nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0919-2026, Z-0918-2026
- Stryker Arise 1000EX mattress, Part Number 2236000000
- Stryker MV3 bariatric bed, Part Number 5900000001
Ongoing Class II Medical devices
- Recall started
- 30 August 2023
- Reason
- Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
- Distribution
- Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0427-2024, Z-0425-2024, Z-0432-2024, Z-0435-2024, Z-0429-2024, Z-0436-2024, Z-0428-2024, Z-0434-2024, Z-0431-2024, Z-0430-2024, Z-0433-2024, Z-0424-2024 and 1 more
- ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
- ProCuity bed series, model number 3009, item number: 3009PX-L-100.
- ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.
- ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
- ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
- ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.
- ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
- ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.
- and 5 more product lines
Ongoing Class II Medical devices
- Recall started
- 24 May 2023
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2130-2023
- Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Numb
Ongoing Class II Medical devices
- Recall started
- 1 February 2023
- 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 while loading/unloading or transport.
- Distribution
- US Nationwide distribution in the states of NY, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1256-2023
- Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
Ongoing Class II Medical devices
- Recall started
- 11 November 2022
- 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.
- Distribution
- Worldwide Distribution: US (Nationwide) and Foreign to countries of: Australia, Canada, Netherlands, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0479-2023
- Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
Ongoing Class II Medical devices
- Recall started
- 12 May 2021
- 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 home users may not be aware of or fully understand these instructions intended for healthcare professionals
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2207-2021, Z-2211-2021, Z-2208-2021, Z-2216-2021, Z-2219-2021, Z-2210-2021, Z-2214-2021, Z-2205-2021, Z-2221-2021, Z-2220-2021, Z-2212-2021, Z-2218-2021 and 7 more
- Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X
- Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿
- Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
- S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX
- Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿
- InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
- S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT
- Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
- and 11 more product lines
Terminated Class II Medical devices
- Recall started
- 12 August 2020
- Terminated
- 2 April 2021
- 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
- Distribution
- US Nationwide distribution including in the states of CA, FL, NY, OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3015-2020
- Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100
Terminated Class II Medical devices
- Recall started
- 7 April 2020
- Terminated
- 22 January 2021
- Reason
- Ambulance Cots may not meet crash test standard BS EN 1789
- Distribution
- Foreign: UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1935-2020
- Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to support and transport the entire body of a traumatized, ambulatory or non-ambulatory
Terminated Class II Medical devices
- Recall started
- 20 November 2018
- Terminated
- 9 July 2020
- Reason
- The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
- Distribution
- US Nationwide and the following foreign countries: Australia, Canada, Netherlands, South Africa, and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1350-2019
- Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
Terminated Class II Medical devices
- Recall started
- 10 October 2018
- Terminated
- 29 April 2020
- 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 Evaluation was completed which identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm. This condition has only presented in regions of high altitude; however, Stryker has chosen to replace all Naera mattresses in the field.
- Distribution
- Nationwide distribution. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Germany, India, Japan, Netherlands, South Africa, Turkey, Saudi Arabia, United Kingdom, and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0813-2019
- Naera Hospital Bassinet, Model No. 4402
Terminated Class II Medical devices
- Recall started
- 8 October 2018
- Terminated
- 28 April 2020
- 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.
- Distribution
- The products were distributed to the following US states: 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, UT, VA, VT, WA, WI, and WY. The products were distributed to t
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0438-2019, Z-0439-2019
- The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
- The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
Terminated Class II Medical devices
- Recall started
- 6 September 2018
- Terminated
- 13 April 2020
- 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 relating to inadvertent flow alarms.3. Users may experience code RFU 27 fault condition relating to mechanical interference between the device fan and filter
- Distribution
- Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0235-2019
- Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the app
Terminated Class II Medical devices
- Recall started
- 13 August 2018
- Terminated
- 21 May 2020
- Reason
- Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
- Distribution
- US Nationwide in the states of: KY, NH, OH, PA, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3181-2018
- IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and d
Terminated Class II Medical devices
- Recall started
- 12 March 2018
- Terminated
- 12 May 2020
- Reason
- The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : Australia, Canada, France, Germany, Hong Kong, Italy, India, Netherlands, Portugal, Saint Martin, Switzerland, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1389-2018
- Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a tran
Terminated Class II Medical devices
- Recall started
- 9 March 2018
- Terminated
- 9 April 2019
- Reason
- The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
- Distribution
- Product distributed to the Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1599-2018, Z-1598-2018
- 6381 M-1 Cot Fastener, catalog no. 6381000000
- 6376 M-1 Cot Fastener, catalog no. 6376000000
Terminated Class III Medical devices
- Recall started
- 7 November 2017
- Terminated
- 9 April 2019
- 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.
- Distribution
- Distributed in all 50 states, the District of Columbia, and Guam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1013-2018
- T/Pump temperature therapy pump, Models TP700 and TP700C
Terminated Class II Medical devices
- Recall started
- 21 July 2017
- Terminated
- 22 March 2018
- Reason
- It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).
- Distribution
- U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0419-2018
- MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.