The Recall Desk
SevereFDA (Devices)·Z-0262-2023·Announced 2022-11-30

3M Steri-Drape General Surgery Drape Recall for Adhesive Skin Injuries

3M is recalling 63,840 units of Steri-Drape surgical drapes worldwide due to reported adhesive-related skin injuries and defective protective liners that are difficult to remove without damaging the product.

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 documented reports of adhesive-related skin injuries in affected lots. The source specifically notes an increase in reported injuries, which constitutes significant injury reports meeting the criteria for a Severe classification.

Plain-English summary

3M Healthcare Business is recalling 63,840 units of 3M Steri-Drape, Medium Drape with Incise Film and Pouch (REF 1061), a general surgery drape. The recall affects 20 specific lot numbers identified by 3M as having manufacturing defects.

The drapes have two problems: the protective liner on the adhesive component is difficult to remove without damaging the product, potentially rendering it unusable. Additionally, 3M has observed an increase in reported adhesive-related skin injuries specifically associated with these affected lots.

These drapes were distributed worldwide. Hospitals, surgical centers, and other healthcare facilities should identify and remove drapes matching the affected lot numbers from use immediately.

Healthcare providers using affected drapes should discontinue use and contact 3M Healthcare Business for replacement or return instructions. Facilities should review their inventory for the recalled lot numbers and ensure all affected units are removed from service.

The recalled product

Product
3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device — Surgical Drapes
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 (20)

  • UDI/DI (01)30707387074068
  • Lot numbers: 33HAEY
  • 33HC74
  • 33HCHP
  • 33JHMA
  • 33JHYT
  • 33JJ8X
  • 33JJHM
  • 33JTNP
  • 33JW4J
  • 33JWDD
  • 33JWLT
  • 33KFNC
  • 33KFY5
  • 33KHK3
  • 33KHWN
  • 33KJ7L
  • 33KJJ7
  • 33KJTC
  • 33KYY7

Distribution

Distribution scope not specified by the agency.

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