3M Steri-Drape surgical drapes recalled for adhesive liner defects and skin injuries
3M is recalling Steri-Drape surgical drapes due to a defective adhesive liner that is difficult to remove and may render the drape unusable. Reported adhesive-related skin injuries have been linked to the 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: This is an FDA Class II recall with reported adhesive-related skin injuries, meeting the Severe classification criterion of significant injury reports associated with an agency Class II designation.
Plain-English summary
3M Healthcare Business is recalling Steri-Drape Medium Drape with Adhesive Aperture (REF 1030), a surgical drape used in general surgery. The recall affects 41,400 units distributed worldwide.
The liner on the adhesive component of affected drapes is difficult to remove without damaging the product and may render it unusable. Additionally, 3M has observed an increase in reported adhesive-related skin injuries associated with the affected lots.
The affected lot numbers are: 33HFW5, 33HH8Y, 33JRFA, 33JTD4, 33KKLW, and 33KL53. The product's unique device identifier (UDI/DI) is (01)30707387018765.
The recalled product
- Product
- 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical drape
- Affected units
- 41,400
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 (7)
- UDI/DI (01)30707387018765
- Lot numbers: 33HFW5
- 33HH8Y
- 33JRFA
- 33JTD4
- 33KKLW
- 33KL53
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 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
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