The Recall Desk
SevereFDA (Devices)·Z-0254-2023·Announced 2022-11-30

3M Steri-Drape Surgical Drape Recall Due to Adhesive Injuries

3M is recalling surgical drapes with defective adhesive components that may cause skin injuries. The adhesive liner is difficult to remove without damaging the product, and increased skin injuries have been reported.

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 criterion: significant injury reports associated with a Class II medical device.

Plain-English summary

3M Healthcare Business is recalling 3M Steri-Drape Small Drape with Adhesive Aperture (REF 1020NS), a surgical drape used in general surgery. The recall affects approximately 220,400 units with worldwide distribution.

The recall was initiated after 3M confirmed that the liner on the adhesive component is difficult to remove without damaging the product, which may render it unusable. Additionally, an increase in reported adhesive-related skin injuries has been observed for the affected lots.

Healthcare facilities and surgical teams using drapes from the affected lot numbers should discontinue use immediately. Contact 3M for instructions regarding return or replacement of affected units.

The recalled product

Product
3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device — Surgical Supply
Hazard
Affected units
220,400

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 (18)

  • UDI/DI (01)30707387226850
  • Lot numbers: 33HPA7
  • 33HPMC
  • 33HRTD
  • 33JHA8
  • 33JHNK
  • 33JJAJ
  • 33K44C
  • 33K4DT
  • 33K5J8
  • 33K5TD
  • 33KEAT
  • 33KFCA
  • 33KFMN
  • 33KH4C
  • 33L47C
  • 33L55C
  • 33LJL7

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

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Same hazard · adhesive skin injury

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