3M Steri-Drape Surgical Drape Recalled for Adhesive Skin Injuries
3M Healthcare is recalling Steri-Drape surgical drapes due to an adhesive component that causes skin injuries and may render the product unusable. Affected: 104,000 units worldwide.
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: This is a Class II FDA-regulated medical device recall with reported adhesive-related skin injuries among users. The documented injury reports meet the rubric criterion for Severe classification.
Plain-English summary
3M Healthcare is recalling 104,000 units of Steri-Drape Small Drape with Incise Film (REF 1021NS) due to problems with the adhesive component liner.
During investigation, 3M confirmed that the liner on the adhesive component is difficult to remove without damaging the product, which may render it unusable. Additionally, 3M has observed an increase in reported adhesive-related skin injuries associated with the affected drapes.
The affected drapes have been distributed worldwide. The recall includes 9 lot numbers: 33HT9W, 33HWN8, 33J5T9, 33JL66, 33JLLW, 33JMKR, 33JN4N, 33K7Y7, and 33K888.
Healthcare facilities and users should identify and quarantine affected drapes and contact 3M for further instructions.
The recalled product
- Product
- 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical Drape
- Affected units
- 104,000
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 (10)
- UDI/DI (01)50707387497410
- Lot numbers: 33HT9W
- 33HWN8
- 33J5T9
- 33JL66
- 33JLLW
- 33JMKR
- 33JN4N
- 33K7Y7
- 33K888
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 drapes recalled due to adhesive defect and skin injuries
FDA (Devices) · 2022-11-30
- Severe3M Steri-Drape surgical drape recalled due to adhesive 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
- ModerateSurgical Injection Tray Recalled Due to Adhesive Liner Defect
FDA (Devices) · 2022-12-07
- ModerateMedline Drape C-SEC Fen Clear Screen Wire Recall
FDA (Devices) · 2026-10-28
- HighFDA Recalls 9,489 Surgical Instrument Kits for Recalled 3M Drapes
FDA (Devices) · 2023-01-11
- HighMedline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk
FDA (Devices) · 2025-03-26