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Open, Classified

BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

FDA Recall Z-0231-2024 · Posted 2023-11-03

Recalling FirmBreg Inc
Recall StatusOpen, Classified
Product CodeITJ
Date Initiated2023-09-13
Product Quantity11,193 units

Reason for Recall

Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.

Firm Action

On 09/13/2023, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx to customer informing them that folding walkers distributed between June 2023 to August 2023 did not meet product specifications for wheel alignment. Products exhibit: -Misalignment of wheels may result in immobility of walker -Misalignment of wheels may result in obstruction of glide/roll Customers are instructed to: -Immediately examine their inventory and quarantine products subject to this recall -For devices separated from labeling, visual examination of devices may be required. The misalignment looks like the wheels are not parallel to each other. -Segregate product with misaligned wheels and return to Breg via Return Material Authorization (RMA or Return Inventory (RI) process. -Review and fill out the response form and return to Breg. For questions, email to [email protected]

Root Cause

Process design

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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