The Recall Desk
SevereFDA (Devices)·Z-0251-2023·Announced 2022-11-30

3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Defects and Skin Injuries

3M is recalling Steri-Drape Large Towel Drapes (REF 1010NS) due to adhesive liner defects that may damage the product and increased reports of adhesive-related skin injuries from 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 constitute significant injury reports meeting the Severe classification criteria.

Plain-English summary

3M Healthcare Business is recalling approximately 807,720 units of Steri-Drape Large Towel Drape (REF 1010NS), a surgical drape for use in general surgery. The company has identified issues with the adhesive component on these drapes. The liner on the adhesive is difficult to remove without damaging the product, which may render the drape unusable. Additionally, 3M has observed an increase in reported skin injuries related to the adhesive in affected lots.

The recalled drapes have been distributed worldwide. Healthcare facilities and consumers with drapes from the affected lot numbers should contact 3M Healthcare Business regarding this recall.

The recalled product

Product
3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device — Surgery Drapes
Hazard
Affected units
807,720

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)50707387023756
  • Lot numbers: 33HR7D
  • 33HR94
  • 33HRET
  • 33HRWK
  • 33HT5X
  • 33HTDY
  • 33J4XP
  • 33J583
  • 33J5FA
  • 33JEF8
  • 33JEM5
  • 33JEYA
  • 33JWHK
  • 33JWLX
  • 33JWRH
  • 33JX5M
  • 33JXFA
  • 33JXPK
  • 33JY6E

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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