3M Steri-Drape surgical drapes recalled due to adhesive skin injuries
3M is recalling 103,000 units of Steri-Drape surgical drapes worldwide due to difficulties removing the adhesive liner and an increase in reported skin injuries from the adhesive.
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 is an FDA Class II recall with reported skin injuries related to the adhesive component. The source indicates an increase in reported skin injuries in the affected lots, which constitutes significant injury reports under the severity rubric.
Plain-English summary
3M Healthcare Business is recalling approximately 103,000 units of Steri-Drape Medium Drape with Incise Film (REF 1060NS). The recall addresses issues identified during a recent investigation: the adhesive liner on the drape's adhesive component is difficult to remove without damaging the product, potentially rendering it unusable. Additionally, 3M has observed an increase in reported skin injuries related to the adhesive in the affected lots.
The affected drapes were distributed worldwide. The recalled lot numbers are 33J7AA, 33J7JY, 33J7W8, 33J8AX, 33J8JR, 33JM8K, 33JMKC, 33JMW3, 33JN9L, 33JNHN, 33JPE6, 33JPM8, 33K8HC, 33K966, and 33K9FK.
The recalled product
- Product
- 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical Drape
- Affected units
- 103,000
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) 50707387029369
- Lot numbers: 33J7AA
- 33J7JY
- 33J7W8
- 33J8AX
- 33J8JR
- 33JM8K
- 33JMKC
- 33JMW3
- 33JN9L
- 33JNHN
- 33JPE6
- 33JPM8
- 33K8HC
- 33K966
- 33K9FK
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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See all →- Severe3M Steri-Drape Surgical Drape Recall Due to Adhesive Injuries
FDA (Devices) · 2022-11-30
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- Severe3M Steri-Drape Medium Drape Recalled for Adhesive Skin Injuries
FDA (Devices) · 2022-11-30
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