The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0750-2019·Announced 2019-01-23

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

Kimberly-Clark is recalling U by Kotex Sleek tampons because they may come apart upon removal. The recall covers 68,852,076 units distributed nationwide and in Canada.

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 is classified as FDA Class II. The hazard involves a structural defect where the tampon may come apart, which poses a risk of harm, but the source text does not report specific injuries or illnesses.

Plain-English summary

Kimberly-Clark Corporation is recalling U by Kotex Sleek, Regular/Super Tampons, 34 Count Multipack. The recall is due to a potential for the tampon to come apart upon removal. The agency classifies this as a Class II recall.

The recall affects 68,852,076 units. These products were distributed nationwide in the United States and internationally to Canada. Specific lot numbers and UPC codes are listed in the official recall notice.

Consumers should stop using the affected tampons and contact Kimberly-Clark for a refund or replacement. The recall number is Z-0750-2019.

The recalled product

Product
U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack
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 (20)

  • Package UPC: 36000426663
  • Case UPC: 10036000426660
  • Lot Numbers: NN629401B
  • NN629501A
  • NN631301B
  • NN631401A
  • NN631401B
  • NN632213A
  • NN632213B
  • NN703113B
  • NN703213A
  • NN705513D
  • NN706513A
  • NN706513B
  • NN706613A
  • NN706613B
  • NN708713A
  • NN708713B
  • NN711413A
  • NN711413B

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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