The Recall Desk
HighFDA (Devices)·Z-0247-2023·Announced 2022-11-30

3M Steri-Drape surgical drape with defective adhesive liner recalled

3M is recalling Steri-Drape Small Towel Drapes because the adhesive liner is difficult to remove without damaging the product and has caused reported skin injuries.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with reported skin injuries from the adhesive component. While injuries have been reported, they are adhesive-related contact injuries without documented hospitalizations or serious injury complications, warranting a High rating rather than Severe.

Plain-English summary

3M Healthcare Business is recalling approximately 503,600 units of the 3M Steri-Drape Small Towel Drape (REF 1000), a general surgery drape distributed worldwide. The affected drapes are identified by UDI/DI (01)30707387057245 and include 83 specific lot numbers.

The recalled drapes contain defective adhesive components. The liner on the adhesive is difficult to remove without damaging the product and may render the drape unusable. In addition, 3M has observed an increase in reported adhesive-related skin injuries for the affected lots.

Healthcare facilities and surgical teams should verify their inventory to identify whether they have drapes from the recalled lot numbers.

The recalled product

Product
3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device — Surgical Drapes
Hazard
Affected units
503,600

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)30707387057245
  • Lot Numbers: 33HD8F
  • 33HDDH
  • 33HDK3
  • 33HDR6
  • 33HDXN
  • 33HECP
  • 33HEM4
  • 33HF3E
  • 33HFAM
  • 33HFFJ
  • 33HFNY
  • 33HFTH
  • 33HTJR
  • 33HTNP
  • 33HTYL
  • 33HW9C
  • 33HWMN
  • 33HX4N
  • 33HXRF

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

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Same hazard · skin injury

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