3M Steri-Drape — Class II medical device recall Z-0264-2023
Ongoing recall by 3M Healthcare Business, reported 2022-11-30. During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is diff
| Recall number | Z-0264-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Healthcare Business, Saint Paul, MN, United States |
| Recall initiated | 2022-10-06 |
| Classified | 2022-11-18 |
| Reported by FDA | 2022-11-30 |
| Quantity | 17,200 units |
| UPC / GTIN / UDI-DI | 30707387018741 |
| Lot numbers | 33HJ3C, 33HTFH, 33J9CT, 33JED6, 33JJHN, 33K968, 33KTRH |
| Model numbers | 1071 |
Product
3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
Reason for recall
During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.
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-0264-2023. 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.