MediChoice Dual-Release Folding Walker with 5" wheel
FDA Device Recall #Z-0416-2015 — Class II — June 25, 2014
Recall Summary
| Recall Number | Z-0416-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 25, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Owens & Minor Distribution, Inc. |
| Location | Mechanicsville, VA |
| Product Type | Devices |
| Quantity | 1214 cases; 4 units/case |
Product Description
MediChoice Dual-Release Folding Walker with 5" wheel
Reason for Recall
Product wheels may be too loose, too tight, or fall off.
Distribution Pattern
US Distribution including the states of CA, CO, CT, GA, IL, MA, MD, ME, MI, NE, NH, NJ, NY, OH, OR, PA, SC, TX, UT, VA, VT, WA and WY.
Lot / Code Information
Item 1314077745. Lot#/Serial #s: 1304CA07A 1307000381-1307001520; 1306CA07A 1307001521-1307002184; 1307CA07A 1307002185-1307002888; 1309CA07A 1307002889-1307003292; 1310CA07A 1307003293-1307004044; 1311CA07A 1307004045-1307004752; 1312CA07A 1307004753-1307005236;
Other Recalls from Owens & Minor Distribution, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1059-2023 | Class III | FLUIDSHIELD 3 Fog-Free Procedure Mask with SO S... | Jan 3, 2023 |
| Z-0343-2023 | Class II | Aero Blue Performance Surgical Gown, XL- Steril... | Oct 31, 2022 |
| Z-0888-2017 | Class II | Medi Choice Arm Slings ASL 2103 Small 7.5 x ... | Oct 31, 2016 |
| Z-0734-2016 | Class II | MediChoice Cohesive Bandages, One (1) roll of c... | Nov 17, 2015 |
| Z-0733-2016 | Class II | MediChoice Cohesive Bandages, One (1) roll of c... | Nov 17, 2015 |
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.