Agency classClass IIOur severity:Severe FDA (Devices)·Z-0262-2023·Announced 2022-11-30

3M Steri-Drape General Surgery Drape Recall for Adhesive Skin Injuries

3M is recalling 63,840 units of Steri-Drape surgical drapes worldwide due to reported adhesive-related skin injuries and defective protective liners that are difficult to remove without damaging the product.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class II recall with documented reports of adhesive-related skin injuries in affected lots. The source specifically notes an increase in reported injuries, which constitutes significant injury reports meeting the criteria for a Severe classification.

Plain-English summary

3M Healthcare Business is recalling 63,840 units of 3M Steri-Drape, Medium Drape with Incise Film and Pouch (REF 1061), a general surgery drape. The recall affects 20 specific lot numbers identified by 3M as having manufacturing defects.

The drapes have two problems: the protective liner on the adhesive component is difficult to remove without damaging the product, potentially rendering it unusable. Additionally, 3M has observed an increase in reported adhesive-related skin injuries specifically associated with these affected lots.

These drapes were distributed worldwide. Hospitals, surgical centers, and other healthcare facilities should identify and remove drapes matching the affected lot numbers from use immediately.

Healthcare providers using affected drapes should discontinue use and contact 3M Healthcare Business for replacement or return instructions. Facilities should review their inventory for the recalled lot numbers and ensure all affected units are removed from service.

The recalled product

Product: 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general surgery drape
Manufacturer: 3M Healthcare Business
Category: Medical Device — Surgical Drapes
Hazard: adhesive-skin-injury
defective-liner
Affected units: 63,840

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)30707387074068
Lot numbers: 33HAEY
33HC74
33HCHP
33JHMA
33JHYT
33JJ8X
33JJHM
33JTNP
33JW4J
33JWDD
33JWLT
33KFNC
33KFY5
33KHK3
33KHWN
33KJ7L
33KJJ7
33KJTC
33KYY7

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 →

Same manufacturer · 3M Healthcare Business

See all →

Severe
3M Steri-Drape Surgical Drape Recall Due to Adhesive Injuries
FDA (Devices) · 2022-11-30
Severe
3M Steri-Drape Surgical Drapes Recalled for Adhesive-Related Skin Injuries
FDA (Devices) · 2022-11-30
High
3M Steri-Drape surgical drape recalled for adhesive skin injuries
FDA (Devices) · 2022-11-30
Severe
3M Steri-Drape surgical drapes recalled for skin injuries and adhesive damage
FDA (Devices) · 2022-11-30
Severe
3M Steri-Drape Medium Drape Recalled for Adhesive Skin Injuries
FDA (Devices) · 2022-11-30

Same hazard · adhesive skin injury