Stryker Medical Division of Stryker Corporation: FDA recalls

FDA enforcement reports name Stryker Medical Division of Stryker Corporation as the recalling firm in 37 events. The events have 80 product records. The recalls started from 2012 to 2026. All the events are device recalls.

See the 37 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

37 events, newest first.

FDA enforcement events of Stryker Medical Division of Stryker Corporation
Initiated	Product (first record)	Type	Class	Records	Status
18 Feb 2026	Cub Pediatric Crib, Model FL19H	Device	Class II	1	Ongoing
31 Oct 2025	Stryker MV3 bariatric bed, Part Number 5900000001	Device	Class II	2	Ongoing
30 Aug 2023	ProCuity bed series, model number 3009, item number: 300900000000,	Device	Class II	13	Ongoing
24 May 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 Number: 6507	Device	Class II	1	Ongoing
1 Feb 2023	Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001	Device	Class II	1	Ongoing
11 Nov 2022	Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)	Device	Class II	1	Ongoing
12 May 2021	Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000	Device	Class II	19	Ongoing
12 Aug 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	Device	Class II	1	Terminated
7 Apr 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 human patient (includes infants and adults).	Device	Class II	1	Terminated
20 Nov 2018	Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000	Device	Class II	1	Terminated
10 Oct 2018	Naera Hospital Bassinet, Model No. 4402	Device	Class II	1	Terminated
8 Oct 2018	The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option	Device	Class II	2	Terminated
6 Sep 2018	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 application of regulating human body temperature in situations where a physician or clinician with…	Device	Class II	1	Terminated
13 Aug 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 deep tissue injury) and is recommended to be implemented in combination with clinical evaluation of risk…	Device	Class II	1	Terminated
12 Mar 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 transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working…	Device	Class II	1	Terminated
9 Mar 2018	6376 M-1 Cot Fastener, catalog no. 6376000000	Device	Class II	2	Terminated
7 Nov 2017	T/Pump temperature therapy pump, Models TP700 and TP700C	Device	Class III	1	Terminated
21 Jul 2017	MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM	Device	Class II	1	Terminated
29 Mar 2017	Medi-Therm Hyper/Hypothermia System, MTA7900	Device	Class II	1	Terminated
8 Nov 2016	Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled	Device	Class II	1	Terminated
5 May 2016	Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments.	Device	Class II	1	Terminated
5 Feb 2016	Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher	Device	Class II	2	Terminated
2 Feb 2016	S3 MedSurg Bed, Model 3005. Stryker Medical	Device	Class II	1	Terminated
3 Dec 2015	Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated control unit to provide changes in the…	Device	Class II	1	Terminated
13 Oct 2015	Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following “parent” devices: Model 2030 (EPIC II),…	Device	Class II	1	Terminated
2 Jul 2015	Spirit One A-C Powered Hospital Bed	Device	Class II	1	Terminated
2 Jul 2015	Spirit One A-C Powered Hospital Bed	Device	Class II	1	Terminated
4 Jun 2014	InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.	Device	Class II	1	Terminated
27 Dec 2013	The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series…	Device	Class II	1	Terminated
26 Nov 2013	Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal…	Device	Class II	2	Terminated
23 Oct 2013	Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails	Device	Class II	1	Terminated
19 Aug 2013	The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE…	Device	Class II	1	Terminated
12 Jul 2013	IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.	Device	Class II	1	Terminated
18 Dec 2012	Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both…	Device	Class II	2	Terminated
11 Oct 2012	The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.	Device	Class II	1	Terminated
27 Jun 2012	Powered Mobility Offers Versatility (M V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In…	Device	Class II	4	Terminated
17 May 2012	GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also…	Device	Class II	5	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Stryker Medical Division of Stryker Corporation: events for each product type
Type		Events
Device		37

Stryker Medical Division of Stryker Corporation: events in each class
Class		Events
Class II		36
Class III		1

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 7

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Stryker Medical Division of Stryker Corporation, by the year that the recall started. The largest year is 2018, with 7 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Stryker Medical Division of Stryker Corporation: FDA recalls. https://recallregister.com/firm/stryker-medical-division-of-stryker-corporation/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: MI

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Stryker Medical Division of Stryker Corporation have?: Class II: 36 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Stryker Medical Division of Stryker Corporation?: FDA event 98426, which the firm started on 18 Feb 2026. The first product in the record is: Cub Pediatric Crib, Model FL19H
How many FDA recalls of Stryker Medical Division of Stryker Corporation have the status Ongoing?: 7 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.