The Recall Desk
SevereFDA (Devices)·Z-0250-2023·Announced 2022-11-30

3M Steri-Drape Surgical Drapes Recalled for Adhesive-Related Skin Injuries

3M is recalling Steri-Drape surgical drapes (large towel drape, REF 1010) distributed worldwide. The affected drapes have reported adhesive-related skin injuries and a liner that is 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 explicitly reported injuries. The source documents an increase in adhesive-related skin injuries on affected lots, meeting the rubric criterion for significant injury reports that justifies a Severe classification.

Plain-English summary

3M Healthcare Business is recalling Steri-Drape Large Towel Drapes (REF 1010), a surgical drape used in operating rooms. The recall affects 2,779,810 units distributed worldwide across specific lot numbers.

The recall is due to two identified issues with the affected drapes. First, the protective liner on the adhesive component is difficult to remove without damaging the drape, potentially rendering it unusable. Second, 3M has observed an increase in reported adhesive-related skin injuries associated with the affected product lots.

Healthcare facilities and surgical centers that have received these drapes should stop using affected lots immediately. Facilities should check their inventory against the provided lot numbers and contact 3M for instructions on product replacement or return.

The recalled product

Product
3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device — Surgical Drapes
Hazard
Affected units
2,779,810

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)30707387057252
  • Lot numbers: 33HAET
  • 33HAPR
  • 33HAYX
  • 33HC8R
  • 33HCEX
  • 33HH47
  • 33HHC9
  • 33HHKA
  • 33HHTA
  • 33HJA9
  • 33HJH7
  • 33HJNT
  • 33HK4K
  • 33HKD8
  • 33HKHT
  • 33HKPP
  • 33HKRT
  • 33HL59
  • 33HL9X

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 injury

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