GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
FDA Device Recall #Z-2223-2021 — Class II — May 12, 2021
Recall Summary
| Recall Number | Z-2223-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 12, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Medical Division of Stryker Corporation |
| Location | Portage, MI |
| Product Type | Devices |
| Quantity | 33 units |
Product Description
GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
Reason for Recall
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 Pattern
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Lot / Code Information
Serial Numbers: R52495 R53376 R55047 R56034 M14805 M14885 M14886 M14931 M14936 M14938 M14939 M50074 M50425 M50951 M50956 M54387 R63407 R54523 R54610 R54696 R54698 R60775 R32649 R25384 R35631 R35734 R58735 M15330 R58474 UDI: 07613327169355 07613327169386
Other Recalls from Stryker Medical Division of Stryker C...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0918-2026 | Class II | Stryker MV3 bariatric bed, Part Number 5900000001 | Oct 31, 2025 |
| Z-0919-2026 | Class II | Stryker Arise 1000EX mattress, Part Number 2236... | Oct 31, 2025 |
| Z-0429-2024 | Class II | ProCuity bed series, model number 3009, item nu... | Aug 30, 2023 |
| Z-0425-2024 | Class II | ProCuity bed series, model number 3009, item nu... | Aug 30, 2023 |
| Z-0427-2024 | Class II | ProCuity bed series, model number 3009, item nu... | Aug 30, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.