Foam Protective Pouches — Class II medical device recall Z-3129-2024
Ongoing recall by Medical Action Industries, Inc. 306, reported 2024-09-18, distributed nationwide. The protective pouches were identified to have been improperly labeled with UDI that is associated with an inc
| Recall number | Z-3129-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Action Industries, Inc. 306, Arden, NC, United States |
| Recall initiated | 2024-06-11 |
| Classified | 2024-09-12 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 5,981,534 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20809160011253, 20809160011260, 20809160011284, 20809160011314, 20809160011369, 20809160011741, 20809160011871, 20809160012069, 20809160012076, 20809160012083, 20809160012090, 20809160012267, 20809160012564 |
| Model numbers | 6010, 6010-1, 6060, 6070, 6106, 6141, 6203, 6805, 6805-1, 6810, 6810-1, 6830, 6860 |
Product
Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 (175 each/case), 6810 (50 each/case), 6810-1 (350 each/case), 6830 (8 rolls/case), and 6860 (8 rolls/case)
Reason for recall
The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foam pouches were misused due to misclassification of the GMDN.
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-3129-2024. 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.