3M Steri-Drape Surgical Drape Recall for Adhesive Defect and Skin Injuries
3M is recalling 554,200 surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and render it unusable. The company has received reports of adhesive-related skin injuries from 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, which constitutes significant injury reports meeting the Severe rating criteria.
Plain-English summary
3M is recalling 554,200 units of the 3M Steri-Drape, Medium Drape with Incise Film and Pouch (REF 1061NS), a sterile surgical drape used in general surgery. The product is distributed worldwide.
The recall is due to a defect in the adhesive liner on the drape. The liner is difficult to remove without damaging the product, which may render the drape unusable for its intended surgical purpose. 3M has also observed an increase in reported adhesive-related skin injuries associated with the affected product lots.
Healthcare facilities and individuals should contact 3M regarding the affected lot numbers to arrange product return or replacement.
The recalled product
- Product
- 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical Drape
- Affected units
- 554,200
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)50707387074079
- Lot numbers: 33HCPF
- 33HD5K
- 33HDAN
- 33HDXM
- 33HEDT
- 33HELW
- 33HEXM
- 33HJRY
- 33HJXT
- 33HK99
- 33HKJJ
- 33HLFP
- 33HLXW
- 33HM9X
- 33HMHE
- 33HMWN
- 33HNLK
- 33HNW9
- 33HP9A
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
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- High3M Steri-Drape surgical drape recalled for adhesive skin injuries
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- Severe3M Steri-Drape surgical drapes recalled for skin injuries and adhesive damage
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- Severe3M Steri-Drape Medium Drape Recalled for Adhesive Skin Injuries
FDA (Devices) · 2022-11-30
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