Stryker Medical Division of Stryker Co

Stryker Medical Division of Stryker Corporation: 80 FDA recall reports

Every medical device recall the FDA has published for Stryker Medical Division of Stryker Corporation. The fault, and how the agency graded it.

80Reports
0Class I
38Ongoing
2026-03-25Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II79
Class III1

By year reported

YearReports
201210
20135
20144
20151
20168
20171
20189
20192
20202
202119
20221
202315
20252
20261
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Cub Pediatric Crib, Model FL19H

Z-1580-2026  ·  Class II  ·  reported 2026-03-25  ·  Ongoing

Why it was recalled
Cribs sold in the USA are missing two access door warning labels.
Product
Cub Pediatric Crib, Model FL19H
Where it went
US Nationwide distribution.
How much
590

Stryker Arise 1000EX mattress, Part Number 2236000000

Z-0919-2026  ·  Class II  ·  reported 2025-12-17  ·  Ongoing

Why it was recalled
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.
Product
Stryker Arise 1000EX mattress, Part Number 2236000000
Where it went
US, nationwide
How much
297 units

Stryker MV3 bariatric bed, Part Number 5900000001

Z-0918-2026  ·  Class II  ·  reported 2025-12-17  ·  Ongoing

Why it was recalled
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.
Product
Stryker MV3 bariatric bed, Part Number 5900000001
Where it went
US, nationwide
How much
294 units

ProCuity bed series, model number 3009, item number: 3009PX-LE-400.

Z-0427-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCuity bed series, model number 3009, item number: 3009PX-L-100.

Z-0425-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCuity bed series, model number 3009, item number: 3009PX-L-100.
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.

Z-0432-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.

Z-0435-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.

Z-0429-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.

Z-0436-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCuity bed series, model number 3009, item number: 3009PX-LE-450.

Z-0428-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCuity bed series, model number 3009, item number: 3009PX-LE-450.
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.

Z-0434-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450.
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCuity bed series, model number 3009, item number: 3009PX-Z-450.

Z-0431-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCuity bed series, model number 3009, item number: 3009PX-Z-450.
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.

Z-0430-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCuity bed series, model number 3009, item number: 3009PX-LEX-450.
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.

Z-0433-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCuity bed series, model number 3009, item number: 3009PX-ZM-600.
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCuity bed series, model number 3009, item number: 300900000000,

Z-0424-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCuity bed series, model number 3009, item number: 300900000000,
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

ProCuity bed series, model number 3009, item number: 3009PX-L-200

Z-0426-2024  ·  Class II  ·  reported 2023-12-13  ·  Ongoing

Why it was recalled
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Product
ProCuity bed series, model number 3009, item number: 3009PX-L-200
Where it went
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.

Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled,

Z-2130-2023  ·  Class II  ·  reported 2023-07-19  ·  Ongoing

Why it was recalled
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.
Product
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
Where it went
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Switzerland, United Kingdom.
How much
1,980 cots

Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency loc

Z-1256-2023  ·  Class II  ·  reported 2023-03-22  ·  Ongoing

Why it was recalled
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.
Product
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
Where it went
US Nationwide distribution in the states of NY, VA.
How much
4 units

Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)

Z-0479-2023  ·  Class II  ·  reported 2022-12-21  ·  Ongoing

Why it was recalled
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.
Product
Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
Where it went
Worldwide Distribution: US (Nationwide) and Foreign to countries of: Australia, Canada, Netherlands, and United Kingdom.
How much
465 (403 US; 62 OUS)

Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and reco

Z-2207-2021  ·  Class II  ·  reported 2021-08-18  ·  Ongoing

Why it was recalled
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
Product
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
Where it went
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
How much
3 units

Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressur

Z-2211-2021  ·  Class II  ·  reported 2021-08-18  ·  Ongoing

Why it was recalled
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
Product
Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿
Where it went
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
How much
1 unit

Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and

Z-2208-2021  ·  Class II  ·  reported 2021-08-18  ·  Ongoing

Why it was recalled
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
Product
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
Where it went
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
How much
1 unit

S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital env

Z-2216-2021  ·  Class II  ·  reported 2021-08-18  ·  Ongoing

Why it was recalled
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
Product
S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX
Where it went
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
How much
4 units

Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating u

Z-2219-2021  ·  Class II  ·  reported 2021-08-18  ·  Ongoing

Why it was recalled
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
Product
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 ¿
Where it went
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
How much
1 unit

InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #14

Z-2210-2021  ·  Class II  ·  reported 2021-08-18  ·  Ongoing

Why it was recalled
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
Product
InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
Where it went
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
How much
2 units

S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital env

Z-2214-2021  ·  Class II  ·  reported 2021-08-18  ·  Ongoing

Why it was recalled
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
Product
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
Where it went
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
How much
21 units

Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position,

Z-2205-2021  ·  Class II  ·  reported 2021-08-18  ·  Ongoing

Why it was recalled
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
Product
Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
Where it went
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
How much
3 units

CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provid

Z-2221-2021  ·  Class II  ·  reported 2021-08-18  ·  Ongoing

Why it was recalled
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
Product
CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000
Where it went
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
How much
2 units

Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿

Z-2220-2021  ·  Class II  ·  reported 2021-08-18  ·  Ongoing

Why it was recalled
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
Product
Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
Where it went
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
How much
1 unit

ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part #

Z-2212-2021  ·  Class II  ·  reported 2021-08-18  ·  Ongoing

Why it was recalled
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
Product
ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009
Where it went
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
How much
3 units

Showing the 30 most recent of 80. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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