Sterile Elastic Esmark Bandage — Class II medical device recall Z-0295-2018
Terminated recall by Medline Industries Inc, reported 2018-01-03, distributed nationwide. Product did not undergo correct sterilization procedures and may potentially be non-sterile.
| Recall number | Z-0295-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2017-07-18 |
| Classified | 2017-12-28 |
| Reported by FDA | 2018-01-03 |
| Terminated | 2020-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, NL, SA |
| Quantity | 5,722 units |
| Reason classes | sterility |
| Lot numbers | 172B2025, 17FB9612, 17GB3101, 17QB8614 |
| Model numbers | 172B2025, 17FB9612, 17GB3101, 17QB8614, DYNJ05914 |
Product
Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.
Reason for recall
Product did not undergo correct sterilization procedures and may potentially be non-sterile.
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-0295-2018. 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.