Agency classClass IIOur severity:Severe FDA (Devices)·Z-0248-2023·Announced 2022-11-30

3M Steri-Drape surgical drapes recalled due to adhesive defect and skin injuries

3M is recalling 504,000 units of Steri-Drape surgical drapes worldwide because the adhesive liner is difficult to remove and may damage the product. Reported cases of adhesive-related skin injuries have been associated with the affected lots.

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: This FDA Class II medical device recall involves reported adhesive-related skin injuries, meeting the rubric criterion for Severe (Score 4): 'significant injury/property-damage reports.' Reported patient injuries constitute significant injury reports, justifying the Severe classification.

Plain-English summary

3M Healthcare Business is recalling 3M Steri-Drape Small Towel Drape (REF 1000NS), a general surgery drape. A total of 504,000 units are affected. The recalled product can be identified by these specific lot numbers: 33HP4H, 33HPDN, 33HPLM, 33HPWP, 33J478, 33J8MT, 33J948, 33JLMY, 33JLWL, 33K6FN, 33KCDK, 33KCP4, 33KY37, 33KYDK, and 33KYNY.

The recall was initiated after 3M confirmed that the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive-related skin injuries for these affected lots.

This product has been distributed worldwide. Healthcare facilities that have received affected lots should immediately discontinue use and contact 3M for return or replacement information.

Any patients or healthcare workers who have experienced adverse events with this product should report the incident to the FDA or contact 3M directly.

The recalled product

Product: 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
Manufacturer: 3M Healthcare Business
Category: Medical Device — Surgical Supplies
Hazard: adhesive-skin-injury
product-defect
Affected units: 504,000

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 (16)

UDI/DI (01)50707387023381
Lot Numbers: 33HP4H
33HPDN
33HPLM
33HPWP
33J478
33J8MT
33J948
33JLMY
33JLWL
33K6FN
33KCDK
33KCP4
33KY37
33KYDK
33KYNY

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