The Recall Desk
SevereFDA (Devices)·Z-0263-2023·Announced 2022-11-30

3M Steri-Drape Surgical Drape Recall for Adhesive Defect and Skin Injuries

3M is recalling 554,200 surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and render it unusable. The company has received reports of adhesive-related skin injuries from 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, which constitutes significant injury reports meeting the Severe rating criteria.

Plain-English summary

3M is recalling 554,200 units of the 3M Steri-Drape, Medium Drape with Incise Film and Pouch (REF 1061NS), a sterile surgical drape used in general surgery. The product is distributed worldwide.

The recall is due to a defect in the adhesive liner on the drape. The liner is difficult to remove without damaging the product, which may render the drape unusable for its intended surgical purpose. 3M has also observed an increase in reported adhesive-related skin injuries associated with the affected product lots.

Healthcare facilities and individuals should contact 3M regarding the affected lot numbers to arrange product return or replacement.

The recalled product

Product
3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device — Surgical Drape
Hazard
Affected units
554,200

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)50707387074079
  • Lot numbers: 33HCPF
  • 33HD5K
  • 33HDAN
  • 33HDXM
  • 33HEDT
  • 33HELW
  • 33HEXM
  • 33HJRY
  • 33HJXT
  • 33HK99
  • 33HKJJ
  • 33HLFP
  • 33HLXW
  • 33HM9X
  • 33HMHE
  • 33HMWN
  • 33HNLK
  • 33HNW9
  • 33HP9A

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

See all →

Same hazard · adhesive defect

See all →