3M Steri-Drape surgical drape recalled due to adhesive skin injuries
3M is recalling Steri-Drape surgical drapes because the liner on the adhesive component is difficult to remove without damaging the drape. An increase in adhesive-related skin injuries has been reported for affected lots.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II recall with reported adhesive-related skin injuries. The observed increase in reported skin injuries represents significant injury reports, meeting the severity criterion for a Severe rating.
Plain-English summary
3M Healthcare Business is recalling 3M Steri-Drape Small Drape with Incise Film (REF 1021), a general surgery drape. This recall affects 36,020 units distributed worldwide. The affected lot numbers are 33H9HW, 33HXMD, 33JKD4, 33JKLL, and 33KPXJ.
During a recent investigation, 3M confirmed that the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the drape unusable. Additionally, 3M has observed an increase in reported adhesive-related skin injuries associated with these affected lots.
The recalled product
- Product
- 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical drape
- Affected units
- 36,020
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI/DI (01)30707387058204
- Lot numbers: 33H9HW
- 33HXMD
- 33JKD4
- 33JKLL
- 33KPXJ
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by 3M Healthcare Business under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
Same manufacturer · 3M Healthcare Business
See all →- Severe3M Steri-Drape Surgical Drape Recall Due to Adhesive Injuries
FDA (Devices) · 2022-11-30
- Severe3M Steri-Drape Surgical Drapes Recalled for Adhesive-Related Skin Injuries
FDA (Devices) · 2022-11-30
- High3M Steri-Drape surgical drape recalled for adhesive skin injuries
FDA (Devices) · 2022-11-30
- Severe3M Steri-Drape surgical drapes recalled for skin injuries and adhesive damage
FDA (Devices) · 2022-11-30
- Severe3M Steri-Drape Medium Drape Recalled for Adhesive Skin Injuries
FDA (Devices) · 2022-11-30
Same hazard · adhesive skin injury
See all →- Severe3M Steri-Drape Surgical Drape Recalled for Adhesive Skin Injuries
FDA (Devices) · 2022-11-30
- Severe3M Steri-Drape surgical drapes recalled due to adhesive defect and skin injuries
FDA (Devices) · 2022-11-30
- Severe3M Steri-Drape General Surgery Drape Recall for Adhesive Skin Injuries
FDA (Devices) · 2022-11-30
- Severe3M Steri-Drape surgical drape recalled for adhesive liner defect and skin injuries
FDA (Devices) · 2022-11-30
Similar recalls
- Moderate3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
- ModerateMedline C-Section Drapes Recalled for Adhesive Removal Issues
FDA (Devices) · 2026-10-28
- ModerateMedline Drape C-SEC Fen Clear Screen Wire Recall
FDA (Devices) · 2026-10-28
- ModerateSurgical Injection Tray Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
- HighMedline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk
FDA (Devices) · 2025-03-26
- ModerateSurgical Convenience Kits Containing Recalled 3M Surgical Drapes
FDA (Devices) · 2022-11-30