U By Kotex recallZ-0749-2019 · Kimberly-Clark Corporation · initiated Dec 11, 2018

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Kimberly-Clark Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for tampon to come apart upon removal.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number: Z-0749-2019
Status: Terminated
Initiated by the company: Dec 11, 2018
Recalling firm: Kimberly-Clark Corporation
Quantity: 68,852,076 units total
Product code: HEB
FDA submissions: K112635
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 description

U by Kotex Sleek, Regular Tampons, 34 Count

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Package UPC: 36000426649; Case UPC: 10036000426646; Lot Numbers: NN628101A, NN628101B, NN628201A, NN628201B, NN629401A, NN629401B, NN631201B, NN631301A, NN632113B, NN632213A, NN633813D, NN634113B, NN634213A, NN635113C, NN703113A, NN703113B, NN705613C, NN706313C, NN706313D, NN706413C, NN706413D, NN707713C, NN707713D, NN711313C, NN711313D, NN711413A, NN713013B, NN713113A, NN714313B, NN714413A, NN714413B, NN719313B, NN719413A, NN722013B, NN722113A, NN722113B, NN722213A, NN724713A, NN724713B, NN726713D, NN726813A, NN728213B, NN728313A, NN729613A, NN729613B, NN729713A, NN732513B, NN732613A, NN733913A, NN733913B, NN735213B, NN735313A, NN801413C, NN801413D, NN802813D, NN802913A, NN804213D, NN804313A, NN805813A, NN805813B, NN807513D, NN807613C, NN809913A, NN811213C, NN811213D, NN815413D, NN816813D, NN818113C, NN818113D, NN822413D, NN822513A, NN824613B, NN824713A, NN826713A.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

U by Kotex Tampon
Kimberly-Clark Global Sales, Inc. · TAMPON, MENSTRUAL, UNSCENTED
1 recall2 reports

Product lines

U By KotexKimberly-Clark Global Sales, Inc. · 42 models · 855 reports · 3 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 81759).

Z-0748-2019 · Terminated
U by Kotex Sleek, Regular Tampons, 18 Count
Z-0750-2019 · Terminated
U by Kotex Sleek, Regular/Super Tampons, 34 Count Multipack

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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