FDA Device recall Z-0257-2023
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape
- FDA Device
- Class II
- ongoing
- Published 2022-11-30
On 2022-11-30 the FDA classified a Class II recall of 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape by 3m Healthcare Business, citing 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 produ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0257-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-06 |
| Published | 2022-11-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | 3m Healthcare Business |
| Distribution | n/a |
Product
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape
Reason
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.
Identifiers
| code_info | UDI/DI (01)30707387018765, Lot numbers: 33HFW5, 33HH8Y, 33JRFA, 33JTD4, 33KKLW, 33KL53 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0257-2023%22
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