The Recall Desk
SevereFDA (Devices)·Z-0258-2023·Announced 2022-11-30

3M Steri-Drape Surgery Drapes Recalled for Adhesive Liner and Skin Injuries

3M is recalling 43,200 units of Steri-Drape surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and reported increases in 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: This FDA Class II medical device recall involves reported adhesive-related skin injuries. The combination of actual injury reports and the potential for product damage in a surgical setting meets the criteria for Severe classification.

Plain-English summary

3M Healthcare Business is recalling 43,200 units of Steri-Drape Medium Drapes with Adhesive Aperture (REF 1030NS). These drapes were distributed worldwide. The recalled lot numbers are 33JPRN, 33JPWY, 33JR98, 33KLEY, and 33KLME.

During its investigation, 3M confirmed that the liner on the adhesive component of the affected drapes is difficult to remove without causing damage that may render the product unusable. Additionally, 3M has identified an increase in reported adhesive-related skin injuries associated with these affected lots.

Healthcare providers who use these drapes should verify whether their facility has inventory matching the recalled lot numbers.

The recalled product

Product
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device — Surgical Drapes
Hazard
  • adhesive-injury
  • product-defect

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)50707387029352
  • Lot numbers: 33JPRN
  • 33JPWY
  • 33JR98
  • 33KLEY
  • 33KLME

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category