The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0748-2019·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 they 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device (tampon) that could result in retained foreign material, which aligns with the rubric criteria for 'structural vehicle defect' or 'significant injury' risks, warranting a Severe classification.

Plain-English summary

Kimberly-Clark Corporation is recalling U by Kotex Sleek, Regular Tampons, 18 Count. The recall involves 68,852,076 units distributed nationwide across 33 states and Puerto Rico, as well as internationally to Canada.

The recall is being issued because there is a potential for the tampon to come apart upon removal. This structural defect could leave parts of the product inside the body.

Consumers should stop using the affected tampons immediately. The specific lot numbers and UPC codes for the recalled product are listed in the official FDA recall notice Z-0748-2019.

The recalled product

Product
U by Kotex¿ Sleek¿, Regular Tampons, 18 Count
Manufacturer
Kimberly-Clark Corporation
Category
Medical Device — Feminine Hygiene
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: 36000294538
  • Case UPC: 10036000294535
  • Lot Numbers: NN628201B
  • NN726913B
  • NN628301A
  • NN728713C
  • NN628301B
  • NN728713D
  • NN629101A
  • NN729813A
  • NN629101B
  • NN731113A
  • NN629201A
  • NN732513B
  • NN630201A
  • NN733713D
  • NN630201B
  • NN733813A
  • NN630301A
  • NN800413B

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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