3M Steri-Drape Surgical Drapes Recalled for Adhesive-Related Skin Injuries
3M is recalling Steri-Drape surgical drapes (large towel drape, REF 1010) distributed worldwide. The affected drapes have reported adhesive-related skin injuries and a liner that is difficult to remove without damaging the product.
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 explicitly reported injuries. The source documents an increase in adhesive-related skin injuries on affected lots, meeting the rubric criterion for significant injury reports that justifies a Severe classification.
Plain-English summary
3M Healthcare Business is recalling Steri-Drape Large Towel Drapes (REF 1010), a surgical drape used in operating rooms. The recall affects 2,779,810 units distributed worldwide across specific lot numbers.
The recall is due to two identified issues with the affected drapes. First, the protective liner on the adhesive component is difficult to remove without damaging the drape, potentially rendering it unusable. Second, 3M has observed an increase in reported adhesive-related skin injuries associated with the affected product lots.
Healthcare facilities and surgical centers that have received these drapes should stop using affected lots immediately. Facilities should check their inventory against the provided lot numbers and contact 3M for instructions on product replacement or return.
The recalled product
- Product
- 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical Drapes
- Affected units
- 2,779,810
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 (20)
- UDI/DI (01)30707387057252
- Lot numbers: 33HAET
- 33HAPR
- 33HAYX
- 33HC8R
- 33HCEX
- 33HH47
- 33HHC9
- 33HHKA
- 33HHTA
- 33HJA9
- 33HJH7
- 33HJNT
- 33HK4K
- 33HKD8
- 33HKHT
- 33HKPP
- 33HKRT
- 33HL59
- 33HL9X
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
- 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
- Severe3M Steri-Drape Surgical Drape Recalled for Adhesive Skin Injuries
FDA (Devices) · 2022-11-30
Same hazard · adhesive injury
See all →- HighAlcon Surgical Procedure Packs Recalled for Adhesive Defect and Skin Injuries
FDA (Devices) · 2022-12-07
- High3M Steri-Drape Surgical Drape Recalled for Adhesive Liner Defect and Skin Injuries
FDA (Devices) · 2022-11-30
- Severe3M Steri-Drape Surgery Drapes Recalled for Adhesive Liner and Skin Injuries
FDA (Devices) · 2022-11-30
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