FDA Device recall Z-1251-2016
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 box…
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of 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 box… by Amd Ritmed, citing product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1251-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-24 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Amd Ritmed |
| Distribution | DE, FL, KY, MI, NE, NJ, PR |
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
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
Identifiers
| code_info | Lot 63927, expiration 2017-04 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1251-2016%22
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