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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81759

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 11, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Kimberly-Clark Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

U by Kotex¿ Sleek¿, Regular Tampons, 18 Count

Z-0748-2019
Recall number
Z-0748-2019
Initiated
December 11, 2018
Classification
Class II
Status
Terminated
Quantity
68,852,076 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for tampon to come apart upon removal.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for tampon to come apart upon removal.

Code information

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.

Distribution pattern

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.

device · product 2 of 4

U by Kotex¿ Sleek¿, Regular Tampons, 34 Count

Z-0749-2019
Recall number
Z-0749-2019
Initiated
December 11, 2018
Classification
Class II
Status
Terminated
Quantity
68,852,076 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for tampon to come apart upon removal.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for tampon to come apart upon removal.

Code information

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.

Distribution pattern

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.

device · product 3 of 4

U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack

Z-0750-2019
Recall number
Z-0750-2019
Initiated
December 11, 2018
Classification
Class II
Status
Terminated
Quantity
68,852,076 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for tampon to come apart upon removal.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for tampon to come apart upon removal.

Code information

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, NN713113A, NN713113B, NN713213C, NN713213D, NN714513B, NN714613C, NN716613A, NN719413B, NN719513C, NN720613B, NN720713A, NN724713B, NN724813A, NN726813A, NN726813B, NN726913A, NN728313A, NN728313B, NN729713A, NN729713B, NN730913C, NN730913D, NN732613B, NN733813B, NN733913A, NN735313A, NN735313B, NN801413D, NN801513A, NN802913A, NN804313A, NN804313B, NN805713B, NN805813A, NN809913B, NN811213D, NN812613D, NN812713A, NN814013C, NN814013D, NN815513A, NN816813D, NN816913A, NN819613C, NN819613D, NN822513A, NN822513B, NN826613C, NN826613D, NN826713A.

Distribution pattern

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.

device · product 4 of 4

U by Kotex¿ Sleek¿, Regular Tampons, 3 Count

Z-0751-2019
Recall number
Z-0751-2019
Initiated
December 11, 2018
Classification
Class II
Status
Terminated
Quantity
68,852,076 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for tampon to come apart upon removal.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for tampon to come apart upon removal.

Code information

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

Distribution pattern

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.

Field note

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