Stryker Medical
3800 E. CENTRE AVE., Portage, MI, US
Registered product codes
27 product codes
Recent MDR events
57,669 on file
- Unknown_Medical_ProductJul 29, 2026Malfunction0001831750-2026-00050
- 6507 POWER PRO 2, HIGH CONFIGJul 28, 2026Malfunction0001831750-2026-99395
- EYE SURGERY STRETCHERJul 28, 2026Malfunction0001831750-2026-99391
- ST104 TRANSPORT OBS 7-2010Jul 28, 2026Malfunction0001831750-2026-99390
- PRIME ZOOM STRETCHER, ELECTRICJul 28, 2026Malfunction0001831750-2026-99392
- LD304 MATERNITY BEDJul 28, 2026Malfunction0001831750-2026-99393
- 6506 MTS PWRPRO COT HIGH CNFIGJul 28, 2026Malfunction0001831750-2026-99394
- MX-PRO R-3 AMBULANCE COTJul 28, 2026Malfunction0001831750-2026-99396
- BIG WHEEL STRETCHER, PRIME XJul 28, 2026Malfunction0001831750-2026-99399
- PRIME ELECTRIC BIG WHEEL STRETCHERJul 28, 2026Malfunction0001831750-2026-99398
Recalls
179 on file
- Open, ClassifiedMar 19, 2026
Cribs sold in the USA are missing two access door warning labels.
View FDA record ↗ - Open, ClassifiedDec 11, 2025
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.
View FDA record ↗ - Open, ClassifiedDec 11, 2025
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.
View FDA record ↗ - Open, ClassifiedDec 1, 2023
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
View FDA record ↗ - Open, ClassifiedDec 1, 2023
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
View FDA record ↗ - Open, ClassifiedDec 1, 2023
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
View FDA record ↗ - Open, ClassifiedDec 1, 2023
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
View FDA record ↗ - Open, ClassifiedDec 1, 2023
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
View FDA record ↗ - Open, ClassifiedDec 1, 2023
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
View FDA record ↗ - Open, ClassifiedDec 1, 2023
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
View FDA record ↗
Compliance history
Matched by FEI 1831750.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Nov 15, 2024
Compliance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(f)Nov 15, 2024
Design verification - Lack of or inadequate procedures
- 21 CFR 820.75(a)Nov 15, 2024
Lack of or inadequate process validation
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.