The Recall Desk
SevereFDA (Devices)·Z-0257-2023·Announced 2022-11-30

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.

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: 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
Hazard
  • adhesive-skin-injury
  • defective-liner

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.

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