The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 →

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