3M Steri-Drape surgical drapes recalled for skin injuries and adhesive damage
3M is recalling 248,750 Steri-Drape surgical drapes used in medical facilities worldwide. The adhesive liner is difficult to remove without damaging the product, and there are reported increases in adhesive-related skin injuries.
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 medical device with reported increase in adhesive-related skin injuries. The combination of reported injury cases with product damage issues meets the rubric criterion for significant injury/property-damage reports.
Plain-English summary
3M is recalling approximately 248,750 units of 3M Steri-Drape, Small Towel Drape (REF 1000NSD), a general surgery drape distributed worldwide. The affected product is identified by specific lot numbers.
The recall was initiated due to issues with the adhesive component: the liner is difficult to remove without damaging the product, and 3M has observed an increase in reported adhesive-related skin injuries for the affected lots. The defects may render the drape unusable.
The recalled product
- Product
- 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device
- Affected units
- 248,750
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 (13)
- UDI/DI (01)50707387445701
- Lot Numbers: 33HCR7
- 33HD4C
- 33J4J6
- 33J4NF
- 33JRKR
- 33JRYN
- 33JT7E
- 33K6D6
- 33KAH8
- 33KAMP
- 33KAY7
- 33KC8K
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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