The Recall Desk
SevereFDA (Devices)·Z-0259-2023·Announced 2022-11-30

3M Steri-Drape Medium Drape Recalled for Adhesive Skin Injuries

3M is recalling approximately 14,360 units of Steri-Drape surgical drapes due to adhesive-related skin injuries. The product's adhesive liner is difficult to remove and may render the drape unusable.

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 device with reported adhesive-related skin injuries affecting over 14,000 units in worldwide distribution. Reported skin injuries on medical devices used in surgical settings constitute significant harm meeting the criteria for Severe classification.

Plain-English summary

3M Healthcare Business is recalling the 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture (REF 1033), a general surgery drape. The adhesive liner on the product is difficult to remove without damaging the product and may render it unusable. 3M has observed an increase in reported adhesive-related skin injuries for the affected lots.

This recall affects approximately 14,360 units distributed worldwide. The affected lot numbers are: 33H9JH, 33J6KY, 33JCP7, 33JRD4, 33JYJ5, 33K6E3, 33KFAC, 33KHKL, 33L6E6, and 33LAXJ. The product's UDI/DI code is (01)3070387454587.

Healthcare providers should identify any affected products in their facilities using the lot numbers provided. Products matching the recalled lots should not be used. Contact 3M directly with questions regarding the recall or if skin injuries have been experienced.

The recalled product

Product
3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device — Surgical Drape
Hazard
Affected units
14,360

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 (11)

  • UDI/DI (01)3070387454587
  • Lot numbers: 33H9JH
  • 33J6KY
  • 33JCP7
  • 33JRD4
  • 33JYJ5
  • 33K6E3
  • 33KFAC
  • 33KHKL
  • 33L6E6
  • 33LAXJ

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 · adhesive skin injury

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