Kerlix Bandage Roll — Class II medical device recall Z-0014-2019
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-0014-2019 |
|---|---|
| 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 | 18D181162, 18D181262, 18E029662, 18E029762, 18E029862, 18E029962, 18E030062, 18E030162, 18E030262, 18E030362, 18E070962, 18E071062, 18E071162, 18E071262, 18E071362, 18E071462, 18E071562, 18E071662, 18E131562, 18E131662, 18E131762, 18E131862, 18E131962, 18E132062, 18E132162, 18E166762, 18E166862, 18E166962, 18E167062, 18E167162, 18E167262, 18E167462, 18E167562, 18E167662, 18E167762, 18E222762, 18E222862, 18E222962, 18E223062, 18E223162 and 27 more |
| Model numbers | 6715 |
Product
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 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-0014-2019. 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.