Z-0748-2019Class II

U by Kotex Sleek, Regular Tampons, 18 Count

Name: Z-0748-2019 U by Kotex Sleek, Regular Tampons, 18 Count
Creator: Kimberly-Clark Corporation
Published: 2018-12-11
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2018-12-11 / Terminated

FDA source

Kimberly-Clark Corporation began a recall of U by Kotex Sleek, Regular Tampons, 18 Count on 2018-12-11. FDA classified it as Class II and gives the reason as "Potential for tampon to come apart upon removal". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0748-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-11
Posted: 2019-01-17
Terminated: 2021-06-02
Recalling firm: Kimberly-Clark Corporation
Product: U by Kotex Sleek, Regular Tampons, 18 Count
Product code: HEB Tampon, Menstrual, Unscented
Reason for recall: Potential for tampon to come apart upon removal.
FDA root cause: Under Investigation by firm
Action: Kimberly-Clark issued a press release on 12/20/2018 and also notified customers via a "MEDICAL DEVICE RECALL" letter. The press release instructed consumers to stop using the product immediately and promptly contact Kimberly-Clark's Consumer Service team at 1-888-255-3499 between 7:30 a.m. 7:00 p.m. Central Time, Monday through Friday, for information regarding this recall. It also indicated that retailers have been alerted to remove the recalled lot numbers from shelves and post a notification in their stores. The customer letter instructed customers to review their store and distribution center inventory to remove affected product from store shelves and inventory, and to post the recall letter in their store. Any affected product should be placed on hold and arrangements should be made with Stericycle at 877-567-9324 for pickup and removal of affected product. If affected product is returned from retail stores, those customers should also make arrangements to send that product to Stericycle. Customers were also provided with and asked to complete and return the provided "Medical Device Recall Form." Questions should be directed to Kimberly-Clark's Consumer Care Team (1-888-255-3499), between 7:30 a.m. 7:00 p.m. Central Time, Monday through Friday. Consumers who experience vaginal injury (pain, bleeding, or discomfort), vaginal irritation (itching or swelling), urogenital infections (bladder and/or vaginal bacterial and/or yeast infections), or other symptoms such as hot flashes, abdominal pain, nausea, or vomiting following use of the impacted product should seek immediate medical attention.
Quantity in commerce: 68,852,076 units total
Distribution: Nationwide distribution AR, AZ, CA, CT, FL, HI, IA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MS, NC, NH, NY, OH, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI. International distribution to Canada.
Product codes and lots: Package UPC: 36000294538; Case UPC: 10036000294535; Lot Numbers: NN628201B, NN726913B, NN628301A, NN728713C, NN628301B, NN728713D, NN629101A, NN729813A, NN629101B, NN731113A, NN629201A, NN732513B, NN630201A, NN733713D, NN630201B, NN733813A, NN630301A, NN800413B, NN632713A, NN800513C, NN632713B, NN802913B, NN634713B, NN803013A, NN634813A, NN804413A, NN635713A, NN804413B, NN635713B, NN807613D, NN701813A, NN807713C, NN701813B, NN808413C, NN701913A, NN808413D, NN703213B, NN812013A, NN705713C, NN812013B, NN705713D, NN812713B, NN705813A, NN812813A, NN707613D, NN814013D, NN707713C, NN814113A, NN711513A, NN814113B, NN711513B, NN815513A, NN715213B, NN815513B, NN715313C, NN819613D, NN715313D, NN819713A, NN716713C, NN821313A, NN716713D, NN822613B, NN718313C, NN822713A, NN720713B, NN824513D, NN723413B, NN824613A, NN723513A, NN824613B, NN724913B, NN826513D, NN725013A, NN826613C, NN726913A, NN827913C.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0748-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0748-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-17
Z-0749-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-17
Z-0750-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-17
Z-0751-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-17

Product code HEB

K112635Class IIU by Kotex Sleek Unscented Menstrual TamponsKimberly-Clark Corp. / cleared 2011-10-07

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)