Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-...
FDA Device Recall #Z-1256-2023 — Class II — February 1, 2023
Recall Summary
| Recall Number | Z-1256-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 1, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Medical Division of Stryker Corporation |
| Location | Portage, MI |
| Product Type | Devices |
| Quantity | 4 units |
Product Description
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
Reason for Recall
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 Pattern
US Nationwide distribution in the states of NY, VA.
Lot / Code Information
GTIN: 07613327559118 Serial Numbers: 2208002066, 2208002071, 2209001508, 2208001664
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| Z-1580-2026 | Class II | Cub Pediatric Crib, Model FL19H | Feb 18, 2026 |
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| Z-0919-2026 | Class II | Stryker Arise 1000EX mattress, Part Number 2236... | Oct 31, 2025 |
| Z-0425-2024 | Class II | ProCuity bed series, model number 3009, item nu... | Aug 30, 2023 |
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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.