The Recall Desk
HighFDA (Devices)·Z-0252-2023·Announced 2022-11-30

3M Steri-Drape Surgical Drape Recalled for Adhesive Liner Defect and Skin Injuries

3M is recalling 84,000 units of Steri-Drape surgical drapes because the adhesive component's liner is difficult to remove without damaging the product, and there have been reported adhesive-related 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 medical device recall with reported adhesive-related skin injuries, elevating it above theoretical risk scenarios. However, without hospitalization reports or explicit characterization of injury severity, it does not meet the threshold for Severe.

Plain-English summary

3M Healthcare Business is recalling 84,000 units of Steri-Drape Large Towel Drape, model REF 1010NSD, used as a general surgery drape. The affected drapes were distributed worldwide with lot numbers 33JE6A, 33JR86, 33JRFK, and 33KD3C.

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

Patients who had surgery using these affected drapes may have been exposed to a potential risk of adhesive-related skin injury. Healthcare facilities and surgical centers that used these specific lot numbers should review their records and contact 3M Healthcare Business for more information.

The recalled product

Product
3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device — Surgical Drapes
Hazard
Affected units
84,000

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 (5)

  • UDI/DI (01)50707387445718
  • Lot numbers: 33JE6A
  • 33JR86
  • 33JRFK
  • 33KD3C

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 injury

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