3M Steri-Drape surgical drape recalled for adhesive skin injuries
3M recalls specific batches of Steri-Drape surgical drapes due to reported adhesive-related skin injuries and potential product damage from difficult-to-remove adhesive liners.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with reported adhesive-related skin injuries. While injuries have been reported, the source does not specify severity level or hospitalization data, placing this in the High category rather than Severe.
Plain-English summary
3M Healthcare Business is recalling specific batches of Steri-Drape Medium Drape with Incise Film (REF 1060), a surgical drape used in general surgery procedures. A total of 26,160 units of the affected product have been identified.
The recall was initiated after 3M confirmed that the adhesive liner on these drapes is difficult to remove without damaging the product, which may render it unusable. Additionally, 3M has reported an increase in cases of skin injuries related to the adhesive component in the affected lots.
The recalled products were distributed worldwide. The affected lot numbers are: 33HT6E, 33HWFM, 33HWMF, 33HX3K, 33K9TF, 33KA3T, and 33KA95, identified by UDI/DI (01)30707387018758.
The recalled product
- Product
- 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical Drapes
- Hazard
- adhesive-skin-injury
- product-defect
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 (8)
- UDI/DI (01)30707387018758
- Lot numbers: 33HT6E
- 33HWFM
- 33HWMF
- 33HX3K
- 33K9TF
- 33KA3T
- 33KA95
Distribution
Distribution scope not specified by the agency.
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