Kimberly-Clark Corporation: U by Kotex Sleek, Regular Tampons, 18 Count

Recall number

Z-0748-2019

Recalling firm

Kimberly-Clark Corporation

Product

U by Kotex Sleek, Regular Tampons, 18 Count

Status

Terminated

Initiated

2018-12-11

Posted

not on file

Terminated

2021-06-02

Reason

Potential for tampon to come apart upon removal.

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

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.

Lot, serial or model codes

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.

510(k) numbers

["K112635"]

PMA numbers

not on file

Product code

HEB

Firm FEI

3003701733

Firm city

Neenah

Firm state

WI

Firm country

not on file

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

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