The Recall Desk
SevereFDA (Devices)·Z-0249-2023·Announced 2022-11-30

3M Steri-Drape surgical drapes recalled for skin injuries and adhesive damage

3M is recalling 248,750 Steri-Drape surgical drapes used in medical facilities worldwide. The adhesive liner is difficult to remove without damaging the product, and there are reported increases in adhesive-related skin injuries.

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 medical device with reported increase in adhesive-related skin injuries. The combination of reported injury cases with product damage issues meets the rubric criterion for significant injury/property-damage reports.

Plain-English summary

3M is recalling approximately 248,750 units of 3M Steri-Drape, Small Towel Drape (REF 1000NSD), a general surgery drape distributed worldwide. The affected product is identified by specific lot numbers.

The recall was initiated due to issues with the adhesive component: the liner is difficult to remove without damaging the product, and 3M has observed an increase in reported adhesive-related skin injuries for the affected lots. The defects may render the drape unusable.

The recalled product

Product
3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device
Hazard
  • skin-injury
  • product-damage

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 (13)

  • UDI/DI (01)50707387445701
  • Lot Numbers: 33HCR7
  • 33HD4C
  • 33J4J6
  • 33J4NF
  • 33JRKR
  • 33JRYN
  • 33JT7E
  • 33K6D6
  • 33KAH8
  • 33KAMP
  • 33KAY7
  • 33KC8K

Distribution

Distribution scope not specified by the agency.

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