Device recall: 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape
Class II FDA enforcement event 90989. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
3M Healthcare Business started this device recall on 6 Oct 2022. The firm address in the FDA record is in Saint Paul, MN. FDA put the recall in Class II. FDA event 90989 has 18 product records. The first FDA enforcement report date is 30 Nov 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution.
Recalling firm
3M Healthcare Business, Saint Paul, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
18 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0247-2023 | 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape | 503,600 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0248-2023 | 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape | 504,000 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0249-2023 | 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape | 248,750 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0250-2023 | 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape | 2,779,810 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0251-2023 | 3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape | 807,720 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0252-2023 | 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape | 84,000 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0253-2023 | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape | 769,810 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0254-2023 | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surgery drape | 220,400 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0255-2023 | 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape | 36,020 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0256-2023 | 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape | 104,000 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0257-2023 | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape | 41,400 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0258-2023 | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape | 43,200 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0259-2023 | 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape | 14,360 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0260-2023 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape | 26,160 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0261-2023 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape | 103,000 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0262-2023 | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general surgery drape | 63,840 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0263-2023 | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape | 554,200 units | Class II | Ongoing | 30 Nov 2022 |
| Z-0264-2023 | 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape | 17,200 units | Class II | Ongoing | 30 Nov 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 18
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0247-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 90989. https://recallregister.com/fda/ii/90989/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution.
- What quantity of product is in FDA event 90989?
- The event has 18 product records. The first record gives this quantity:
503,600 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.