3M Steri-Drape surgical drape recalled for adhesive liner defect and skin injuries
3M is recalling 769,810 Steri-Drape surgical drapes worldwide due to a defective adhesive liner that is difficult to remove and has caused reported skin injuries.
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 medical device recall with reported increases in adhesive-related skin injuries. The defect prevents safe removal of the adhesive liner without damaging the product, which may render it unusable in surgical settings.
Plain-English summary
3M Healthcare Business is recalling 769,810 units of 3M Steri-Drape surgical drapes (small drape with adhesive aperture, REF 1020) distributed worldwide. The recall affects multiple lot numbers following an investigation that confirmed defects in the adhesive component.
The adhesive liner on the affected drapes is difficult to remove without damaging the product, potentially rendering it unusable. Additionally, 3M has observed an increase in reported skin injuries related to the adhesive. The product is used in general surgery to protect the surgical site during procedures.
Consumers and healthcare facilities using affected lots should discontinue use immediately. Affected lot numbers are listed in the FDA recall database. Healthcare providers and consumers should contact 3M Healthcare Business or the FDA for additional information about the recalled product.
The recalled product
- Product
- 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical Drapes
- Affected units
- 769,810
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)30707387018772
- Lot numbers: 33H9T5
- 33HA9D
- 33HC7R
- 33HCJN
- 33HCPL
- 33HD6C
- 33HDYW
- 33HEDM
- 33HELH
- 33HF3X
- 33HFXP
- 33HH8C
- 33HHKC
- 33HJ3K
- 33HK5H
- 33HKJH
- 33HKPA
- 33HLKE
- 33HLWT
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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