FDA Medical Device Recalls (openFDA)
3M Company - Health Care Business: 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
- Recall number
- Z-0719-2020
- Recalling firm
- 3M Company - Health Care Business
- Product
- 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
- Status
- Terminated
- Initiated
- 2019-11-21
- Posted
- not on file
- Terminated
- 2021-04-23
- Reason
- While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape to continuous high moisture clinical applications has not fully met all of 3M s performance expectations. This use environment may cause tape bond failure, leading the tape to not perform as intended. Further, the tape fibers may fray which could be accidentally ingested or aspirated.
- Root cause
- Device Design
- Action
- The firm initiated the recall by letter on 11/20/2019. The letter explained the failures seen and requested the following actions be taken: 1. Immediately cease use of the product and quarantine it for destruction/disposal. 2. Complete the attached Customer Acknowledgement Form with the following: - Acknowledge that you have read and understood this letter whether or not you have any 3M" Durapore" Advanced Surgical Tape 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 3Mhealthcare@montage72.com 3. If there are clinical questions, contact Kimberly Schommer, RN, BSN via the 3M Health Care Customer Helpline at 1-800-228-3957.
- Quantity
- 470,954 rolls
- Distribution
- Nationwide, Canada, Germany, France, Switzerland, Denmark
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KGX
- Firm FEI
- 2110898
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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