IMCO brand Conforming Stretch Gauze Bandages — Class II medical device recall Z-1251-2016
Terminated recall by Amd Ritmed, reported 2016-04-06, distributed in DE, FL, KY, MI, NE, NJ, PR. Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
| Recall number | Z-1251-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amd Ritmed, Lachine, N/A, Canada |
| Recall initiated | 2016-02-24 |
| Classified | 2016-03-25 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2016-07-08 |
| Distributed | DE, FL, KY, MI, NE, NJ, PR |
| Countries outside the US | CA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00686864043515 |
| Lot numbers | 2017-04, 63927 |
Product
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in health care facilities
Reason for recall
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
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-1251-2016. 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.