CURAD REUSABLE GEL HOT/COLD PACK — Class II medical device recall Z-0633-2022
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2022-02-16. The product contains natural rubber latex but the label states that it does not.
| Recall number | Z-0633-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2021-12-15 |
| Classified | 2022-02-09 |
| Reported by FDA | 2022-02-16 |
| Countries outside the US | BB, BM, BS, HN, LB, PA |
| Quantity | 494,273 units |
| Reason classes | labeling |
| Lot numbers | 69718070004, 69718080002, 69718090002, 69718090003, 69718100001, 69718100004, 69718110003, 69719010001, 69719030001, 69719030004, 69719040002, 69719050002, 69719050004, 69719060001, 69719060003, 69719070001, 69719070005, 69719080002, 69719080006, 69719090001, 69719090004, 69719100001, 69719100004, 69719100005, 69719110001, 69719110002, 69719110003, 69719110004, 69719120001, 69719120002, 69719120005, 69719120006, 69719120007, 69720010001, 69720020002, 69720040001, 69720050001, 69720060001, 69720060002, 69720070001 and 23 more |
Product
CURAD REUSABLE GEL HOT/COLD PACK
Reason for recall
The product contains natural rubber latex but the label states that it does not.
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-0633-2022. 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.