3M Steri-Drape Medium Drape Recalled for Adhesive Skin Injuries
3M is recalling approximately 14,360 units of Steri-Drape surgical drapes due to adhesive-related skin injuries. The product's adhesive liner is difficult to remove and may render the drape unusable.
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 device with reported adhesive-related skin injuries affecting over 14,000 units in worldwide distribution. Reported skin injuries on medical devices used in surgical settings constitute significant harm meeting the criteria for Severe classification.
Plain-English summary
3M Healthcare Business is recalling the 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture (REF 1033), a general surgery drape. The adhesive liner on the product is difficult to remove without damaging the product and may render it unusable. 3M has observed an increase in reported adhesive-related skin injuries for the affected lots.
This recall affects approximately 14,360 units distributed worldwide. The affected lot numbers are: 33H9JH, 33J6KY, 33JCP7, 33JRD4, 33JYJ5, 33K6E3, 33KFAC, 33KHKL, 33L6E6, and 33LAXJ. The product's UDI/DI code is (01)3070387454587.
Healthcare providers should identify any affected products in their facilities using the lot numbers provided. Products matching the recalled lots should not be used. Contact 3M directly with questions regarding the recall or if skin injuries have been experienced.
The recalled product
- Product
- 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical Drape
- Affected units
- 14,360
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 (11)
- UDI/DI (01)3070387454587
- Lot numbers: 33H9JH
- 33J6KY
- 33JCP7
- 33JRD4
- 33JYJ5
- 33K6E3
- 33KFAC
- 33KHKL
- 33L6E6
- 33LAXJ
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 Surgical 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
- ModerateMedline Drape C-SEC Fen Clear Screen Wire Recall
FDA (Devices) · 2026-10-28
- 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
- SevereCustomed Full Body Drape Recalled for Sterility Compromise
FDA (Devices) · 2014-12-10