S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units o...
FDA Device Recall #Z-0618-2014 — Class II — November 26, 2013
Recall Summary
| Recall Number | Z-0618-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 26, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Medical Division of Stryker Corporation |
| Location | Portage, MI |
| Product Type | Devices |
| Quantity | 108,769 Total |
Product Description
S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components.
Reason for Recall
Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, China, Argentina, Brazil, Germany, Korea, Mexico, Singapore, UK, Europe, Middle East, Africa, and Latin America.
Lot / Code Information
Models: 3002 S3 EX, 3002 S3 PATRIOT, 3002 S3 CUSTOM, 3002 S3 ZOOM, and 3002 S3 SIGNATURE. 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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.