Ferno Model 35X PROFlexx Stretchers, one unit per package
FDA Device Recall #Z-0995-2015 — Class II — December 3, 2014
Recall Summary
| Recall Number | Z-0995-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 3, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ferno-Washington Inc |
| Location | Wilmington, OH |
| Product Type | Devices |
| Quantity | 46 units |
Product Description
Ferno Model 35X PROFlexx Stretchers, one unit per package
Reason for Recall
The wheel castor assemblies may be loosening on the stretchers.
Distribution Pattern
The affected product was distributed to the following states: OH, MA, HI, NJ, TN, TX, MO, and GA. The affected product was distributed to the following foreign countries: Canada, Germany and Venezuela.
Lot / Code Information
The following serial numbers are affected by this recall: 13N272700 13N273357 13N273915 13N274967 13N275720 13N272701 13N273358 13N273916 13N274968 13N275721 13N272702 13N273359 13N273917 13N274969 13N275722 13N272703 13N273360 13N274387 13N274970 13N275723 13N272704 13N273361 13N274388 13N274971 13N275724 13N272705 13N273362 13N274389 13N274972 13N275725 13N273353 13N273363 13N274390 13N274973 13N275726 13N273354 13N273902 13N274391 13N275717 13N273355 13N273913 13N274965 13N275718 13N273356 13N273914 13N274966 13N275719
Other Recalls from Ferno-Washington Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0133-2026 | Class II | FERNO POWER X2 POWERED AMBULANCE COT, Model/Cat... | Sep 11, 2025 |
| Z-0184-2023 | Class II | FERNO POWER X1 AMBULANCE COT- Item #0015807/UD... | Oct 7, 2022 |
| Z-1827-2017 | Class II | Ferno PROFlexx¿ Model 28Z Chair Cot | Mar 8, 2017 |
| Z-1603-2016 | Class II | Poly-bags containing splint strap labeled with ... | Mar 10, 2016 |
| Z-1604-2016 | Class II | Poly-bags containing the strap labeled with "Ad... | Mar 10, 2016 |
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.