BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
FDA Device Recall #Z-0231-2024 — Class II — September 13, 2023
Recall Summary
| Recall Number | Z-0231-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 13, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Breg Inc |
| Location | Carlsbad, CA |
| Product Type | Devices |
| Quantity | 11,193 units |
Product Description
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
Reason for Recall
Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
Distribution Pattern
U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY. O.U.S.: N/A
Lot / Code Information
Model/Product Number - 100519-000 UDI-DI Code: 00672736130834 Lot Numbers: CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, CM82531223
Other Recalls from Breg Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1905-2017 | Class II | Dressing Shldr, P/N 04908 Product Usage: Th... | Mar 30, 2017 |
| Z-1908-2017 | Class II | If Hip, Sterile Polar Dressing P/N 10680 Pro... | Mar 30, 2017 |
| Z-1903-2017 | Class II | Dressing Rect L, P/N 02428 Product Usage: T... | Mar 30, 2017 |
| Z-1901-2017 | Class II | Dressing Knee/Shldr, P/N 02328 Product Usage... | Mar 30, 2017 |
| Z-1904-2017 | Class II | Dressing, Knee L/XL, P/N 04708 Product Usage... | Mar 30, 2017 |
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.