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
Affected units
248,750

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.

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 · skin injury

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