Saint Paul, MN, United States
3M Healthcare Business recalls
1 recall recorded since 2018, most recently on 6 October 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 6 October 2022
- Reason
- During a recent investigation, 3M confirmed 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.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0253-2023, Z-0250-2023, Z-0260-2023, Z-0249-2023, Z-0264-2023, Z-0252-2023, Z-0259-2023, Z-0258-2023, Z-0251-2023, Z-0261-2023, Z-0256-2023, Z-0248-2023 and 6 more
- 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape
- 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
- 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape
- 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
- 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
- 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape
- 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape
- 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape
- and 10 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.