CLASS II ONGOING Device recall · Reported 30 Nov 2022 · FDA Enforcement Report
3M Steri-Drape, Small Drape with Incise Film recalled
3M Healthcare Business is recalling 3M Steri-Drape, Small Drape with Incise Film. The recall was initiated on 6 Oct 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0256-2023
- FDA event ID
- 90989
- Recalling firm
- 3M Healthcare Business, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Oct 2022
- FDA classified
- 18 Nov 2022
- Reported
- 30 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 6 Oct 2022 | Recall initiated by company | |
| 18 Nov 2022 | Classified by FDA | +43 days |
| 30 Nov 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape
Where it was distributed
Worldwide distribution.
Questions about this recall
Is 3M Steri-Drape, Small Drape with Incise Film recalled?
Yes. 3M Healthcare Business recalled 3M Steri-Drape, Small Drape with Incise Film on 6 Oct 2022. The recall is Class II and its status is Ongoing. Recall number Z-0256-2023.
Why was it recalled?
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.
Which lots are affected?
UDI/DI (01)50707387497410, Lot numbers: 33HT9W, 33HWN8, 33J5T9, 33JL66, 33JLLW, 33JMKR, 33JN4N, 33K7Y7, 33K888
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from 3M Healthcare Business
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 3M Steri-Drape, Small Towel Drape recalled by 3M Healthcare Business | 3M Healthcare Business | Other | MN |
| Device | CLASS II | 3M Steri-Drape, Small Drape with Adhesive Aperture recalled | 3M Healthcare Business | Other | MN |
| Device | CLASS II | 3M Steri-Drape, Medium Drape with Incise Film recalled | 3M Healthcare Business | Other | MN |
| Device | CLASS II | 3M Steri-Drape, Medium Drape with Incise Film recalled | 3M Healthcare Business | Other | MN |
| Device | CLASS II | 3M Steri-Drape, Medium Drape with Adhesive Aperture recalled | 3M Healthcare Business | Other | MN |
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