Quick Release Gait Belt — Class II medical device recall Z-0055-2021
Ongoing recall by Medline Industries Inc, reported 2020-10-14, distributed in IL, MI. The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
| Recall number | Z-0055-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2020-09-15 |
| Classified | 2020-10-05 |
| Reported by FDA | 2020-10-14 |
| Distributed | IL, MI |
| Quantity | 13,500 units |
| Reason classes | specification failure, device malfunction |
| Lot numbers | 20EBB832, 20EBM643, 33019040001, 33019090001, 33019100001 |
| Model numbers | 20EBB832, 20EBM643, 33019040001, 33019090001, 33019100001, 503689, DYKF1045, MDT821208NATM |
Product
Quick Release Gait Belt, 60
Reason for recall
The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0055-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.