The Recall Desk
SevereFDA (Devices)·Z-0255-2023·Announced 2022-11-30

3M Steri-Drape surgical drape recalled due to adhesive skin injuries

3M is recalling Steri-Drape surgical drapes because the liner on the adhesive component is difficult to remove without damaging the drape. An increase in adhesive-related skin injuries has been reported for 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: FDA Class II recall with reported adhesive-related skin injuries. The observed increase in reported skin injuries represents significant injury reports, meeting the severity criterion for a Severe rating.

Plain-English summary

3M Healthcare Business is recalling 3M Steri-Drape Small Drape with Incise Film (REF 1021), a general surgery drape. This recall affects 36,020 units distributed worldwide. The affected lot numbers are 33H9HW, 33HXMD, 33JKD4, 33JKLL, and 33KPXJ.

During a recent investigation, 3M confirmed that the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the drape unusable. Additionally, 3M has observed an increase in reported adhesive-related skin injuries associated with these affected lots.

The recalled product

Product
3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device — Surgical drape
Hazard
  • adhesive-skin-injury
  • difficult-removal

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 (6)

  • UDI/DI (01)30707387058204
  • Lot numbers: 33H9HW
  • 33HXMD
  • 33JKD4
  • 33JKLL
  • 33KPXJ

Distribution

Distribution scope not specified by the agency.

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