FDA Medical Device Recalls (openFDA)
3M Healthcare Business: 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
- Recall number
- Z-0248-2023
- Recalling firm
- 3M Healthcare Business
- Product
- 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
- Status
- Open, Classified
- Initiated
- 2022-10-06
- Posted
- 2022-11-18
- Terminated
- not on file
- 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.
- 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 3MFieldSafetyAction@montage72.com. 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 3MFieldSafetyAction@montage72.com." 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 3MFieldSafetyAction@montage72.com. 4. To request credit, contact 3M Health Care Customer Helpline at 1-800-228-3957, option 7 or by email t
- Quantity
- 504,000 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- UDI/DI (01)50707387023381, Lot Numbers: 33HP4H, 33HPDN, 33HPLM, 33HPWP, 33J478, 33J8MT, 33J948, 33JLMY, 33JLWL, 33K6FN, 33KCDK, 33KCP4, 33KY37, 33KYDK, 33KYNY
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PUI
- Firm FEI
- 2126770
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28