Z-1633-2024Class II

3M Durapore Surgical Tape, Catalog Number 1538-118

Name: Z-1633-2024 3M Durapore Surgical Tape, Catalog Number 1538-118
Creator: 3M Company - Health Care Business
Published: 2024-03-20
License: https://open.fda.gov/license/

3M Company / initiated 2024-03-20 / Open, Classified / root cause: labeling and UDI

FDA source

3M Company - Health Care Business began a recall of 3M Durapore Surgical Tape, Catalog Number 1538-118 on 2024-03-20. FDA classified it as Class II and gives the reason as "Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1633-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-20
Posted: 2024-04-24
Recalling firm: 3M Company
Product: 3M Durapore Surgical Tape, Catalog Number 1538-118
Product code: KGX Tape And Bandage, Adhesive
Reason for recall: Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 3M issued an URGENT: Voluntary Product Recall to its consignees on 03/20/2024 via email and USPS certified mail. The notice explained the issue and requested the following: Identify all affected lots in inventory (bulk) or built into kits, including kits that have been distributed. Bulk inventory: use Appendix 1 to determine the correct expiration dates to use when building kits. a. If the affected product in inventory is within the correct expiration date for the affected product correct the expiration date on the bulk package label and ensure future kits reflect the correct expiration date for the 3M affected product. b. If the affected product in inventory exceeds the correct expiration date, please destroy per facility policy. 3. Kits: Review the affected 3M lots that have been built into kits. Using Appendix 1 to determine the correct expiration date for each lot, assess if the expiration date of the kit is within the correct expiration date for the affected product. a. If the kit was labeled within the correct expiration date for the affected product, no action is required for kits in inventory nor for any kits you have distributed. b. If the kit was labeled with an expiration date exceeding the correct expiration date of the affected product, action is required. i. Kit inventory: Take action to rectify the expiration date of the kit according to the correct expiration date of the affected product or destroy the kits per facility policy. ii. Kits that have been distributed: If you have distributed kits labeled with an expiration date exceeding the correct expiration date of the affected product, please notify the impacted customers of this issue and FDA of your intent to recall/correct the affected kits. To request replacement product for the destroyed 3M Durapore Surgical Tape, Catalog Number 1538-118 product, contact 3M Health Care Customer Helpline to submit all replacement requests by calling 1-800-228-3957, option #7, or by email to 3MF
Quantity in commerce: 3,515,200 rolls
Distribution: Worldwide distribution - US Nationwide in the states of TX, NY, NH, AZ, NC, CA, IL, GA, VA, MD, FL, and the country of Canada.
Product codes and lots: UDI/DI 50707387793208, Lot Codes: 33DER3, 33DTMA, 33DTPN, 33EDDE, 33ETFA, 33ETHX, 33FDHA, 33FDYN, 33FE9D, 33FEY6, 33FTLA, 33FW6E, 33FWPC, 33JE7T, 33JEFK, 33JENC, 33JYPX, 33JYW5, 33K3EJ, 33KPWT, 33KT6R, 33KT8F, 33LJWC, 33LK5M, 33LLEY, 33LLPT, 33LM6R, 33LMET, 33LMX3, 33N56W, 33N5K4, 33N5TC, 33NF36, 33NF6A, 33NY98, 33NYP9, 33P37P, 33PKLN, 33PL6J, 33PMFA, 33R35M, 33R3P6, 33RMNF, 33RNP4, 33TL39, 33TL8F, 33TLF4, 33TN55, 33WEA8, 33WEHJ, 33WERX, 33WF5P, 33WFD5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1633-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1633-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-24

Product code KGX

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)