AMD-RITMED brand Conforming Stretch Gauze Bandages — Class II medical device recall Z-2213-2016
Terminated recall by Amd-Ritmed, Inc., reported 2016-07-27, distributed in CA, NY, TN. The product lot did not meet sterility requirements based on FDA sampling and analysis.
| Recall number | Z-2213-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amd-Ritmed, Inc., Tonawanda, NY, United States |
| Recall initiated | 2016-03-30 |
| Classified | 2016-07-15 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2016-07-15 |
| Distributed | CA, NY, TN |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00686864042303 |
| Lot numbers | 2017-06, 64155 |
Product
AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.
Reason for recall
The product lot did not meet sterility requirements based on FDA sampling and analysis.
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-2213-2016. 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.