Dermacea Gauze Fluff Roll — Class II medical device recall Z-0017-2019
Terminated recall by COVIDIEN LLC, reported 2018-10-10, distributed nationwide. Potential for product sterility breach due to a compromised or pinched seal defect
| Recall number | Z-0017-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | COVIDIEN LLC, Mansfield, MA, United States |
| Recall initiated | 2018-08-01 |
| Classified | 2018-10-02 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2020-06-03 |
| Distributed | Nationwide (US) |
| Quantity | 2,730,821 units |
| Reason classes | sterility, packaging |
| Lot numbers | 18D180662, 18E070362, 18E222362, 18F072362 |
| Model numbers | 441103 |
Product
Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Reason for recall
Potential for product sterility breach due to a compromised or pinched seal defect
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-0017-2019. 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.