Z-0261-2023Class II

3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape

Name: Z-0261-2023 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape
Creator: 3M Healthcare Business
Published: 2022-10-06
License: https://open.fda.gov/license/

3M Healthcare Business / initiated 2022-10-06 / Open, Classified

FDA source

3M Healthcare Business began a recall of 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape on 2022-10-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0261-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-06
Posted: 2022-11-18
Recalling firm: 3M Healthcare Business
Product: 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape
Product code: PUI Drape, Surgical, Exempt
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.
FDA root cause: Component change control
Action: The firm began disseminating an URGENT Product Recall notice their consignees by email or letter beginning 10/06/2022. The notice explained the issue and requested the following: Distributors: "Actions Requested: 1. Immediately discontinue distribution of affected models and lots of 3M" Steri-Drape" Surgical Drapes. Reference Attachment 1 for list of models and lots. 2. Determine if any stock of the affected models and lots remain in inventory. 3. Complete the Distributor Acknowledgement Form with the following: " Acknowledge that you have read and understood this letter whether or not you have any 3M" Steri-Drape" Surgical Drapes in stock at your facility; and " Indicate if you have any product in stock and dispose of this material per facility policy. " Email the completed form to [email protected]. 4. Notify any of your customers who have purchased this product using the Customer Letter and Customer Acknowledgement Form provided. 5. To request credit, contact 3M Health Care Customer Helpline at 1-800-228-3957, option 7 or by email to [email protected]." Direct accounts: "Actions Requested: 1. Immediately cease use of affected models and lots of 3M" Steri-Drape" Surgical Drapes. Reference Attachment 1 for list of models and lots. 2. Determine if any stock of the affected models and lots remain in inventory. NOTE: if you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 3. Complete the Customer Acknowledgement Form with the following: " Acknowledge that you have read and understood this letter whether or not you have any 3M" Steri-Drape" Surgical Drapes in stock at your facility; and " Indicate if you have any product in stock and dispose of this material per facility policy. " Email the completed form to [email protected]. 4. To request credit, contact 3M Health Care Customer Helpline at 1-800-228-3957, option 7 or by email t
Quantity in commerce: 103,000 units
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI (01) 50707387029369, Lot numbers: 33J7AA, 33J7JY, 33J7W8, 33J8AX, 33J8JR, 33JM8K, 33JMKC, 33JMW3, 33JN9L, 33JNHN, 33JPE6, 33JPM8, 33K8HC, 33K966, 33K9FK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0261-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0247-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0248-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0249-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0250-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0251-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0252-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0253-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0254-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0255-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0256-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0257-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0258-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0259-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0260-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0261-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0262-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0263-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18
Z-0264-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18

Product code PUI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)