The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0751-2019·Announced 2019-01-23

Kimberly-Clark Recalls U by Kotex Sleek Tampons for Structural Defect

Kimberly-Clark is recalling U by Kotex Sleek Regular Tampons because the product may come apart upon removal.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device (tampon) where the product may come apart, posing a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Kimberly-Clark Corporation is recalling U by Kotex Sleek, Regular Tampons, 3 Count. The recall is due to a potential for the tampon to come apart upon removal.

The affected product was distributed nationwide in the United States and internationally to Canada. The specific states listed for distribution include 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, and WI.

Consumers should stop using the affected tampons. The recall involves specific lot numbers: XM700604X, XM700904X, XM702304X, XM702404X, and XM702504X. The package UPC is 36000423372 and the case UPC is 10036000459296.

The recalled product

Product
U by Kotex¿ Sleek¿, Regular Tampons, 3 Count
Manufacturer
Kimberly-Clark Corporation
Category
Medical Device — Tampons
Hazard
Affected units
68,852,076

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Package UPC: 36000423372
  • Case UPC: 10036000459296
  • Lot Numbers: XM700604X
  • XM700904X
  • XM702304X
  • XM702404X
  • XM702504X.

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Kimberly-Clark Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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