The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lowe...
FDA Device Recall #Z-0566-2013 — Class II — October 11, 2012
Recall Summary
| Recall Number | Z-0566-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 11, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Medical Division of Stryker Corporation |
| Location | Portage, MI |
| Product Type | Devices |
| Quantity | 24 |
Product Description
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.
Reason for Recall
Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted.
Distribution Pattern
USA, Nationwide including the states of PA, NM, MI, IA, CA, CO, WA, VA, IL, WI, NY, WY, MO, TX, and CT.
Lot / Code Information
Item 6390000000 Serial Numbers: 120940217 120940257 120940259 120940260 120940261 120940275 120940276 120940277 120940290 120940291 120940292 120940293 120940294 120940431 120940435 120940436 120940437 120940448 120940449 120940454 120940458 120940459 120940203 120940258
Other Recalls from Stryker Medical Division of Stryker C...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1580-2026 | Class II | Cub Pediatric Crib, Model FL19H | Feb 18, 2026 |
| 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 |
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.