The Recall Desk
SevereFDA (Devices)·Z-0253-2023·Announced 2022-11-30

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
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

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Same hazard · adhesive skin injury

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