3M Durapore Advanced — Class II medical device recall Z-0719-2020
Terminated recall by 3M Company - Health Care Business, reported 2020-01-01, distributed nationwide. While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical
| Recall number | Z-0719-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Company - Health Care Business, Saint Paul, MN, United States |
| Recall initiated | 2019-11-21 |
| Classified | 2019-12-20 |
| Reported by FDA | 2020-01-01 |
| Terminated | 2021-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, DE, DK, FR |
| Quantity | 470,954 rolls |
| Model numbers | 1590-0, 1590-1, 1590-2, 1590-3, 1590B-118, 1590B-136, 1590S-1, 1590S-2, 1591-0, 1591-1, 1591-2, 1591-3 |
Product
3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
Reason for recall
While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape to continuous high moisture clinical applications has not fully met all of 3M s performance expectations. This use environment may cause tape bond failure, leading the tape to not perform as intended. Further, the tape fibers may fray which could be accidentally ingested or aspirated.
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-0719-2020. 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.