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Kimberly-Clark Corporation

Also registered as Kimberly-Clark, Kimberly-Clark Corp.

Country not established FDA establishment FEI 3003701733

Devices
122
Registrations
FDA
FDA recalls
35

Catalogue122

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Company details

FDA FEI number
3003701733
Address
2100 WINCHESTER RD., NEENAH, WI, 54956

FDA recalls35

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 4
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

31 initiated before 2017

Showing the 10 most recent of 35 recalls.

  • 2018

    • 11 Dec 2018 Z-0748-2019 Class II Terminated Potential for tampon to come apart upon removal. 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,…
      Full distribution text 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.
      Submission number: K112635
    • 11 Dec 2018 Z-0749-2019 Class II Terminated Potential for tampon to come apart upon removal. 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,…
      Full distribution text 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.
      Submission number: K112635
    • 11 Dec 2018 Z-0750-2019 Class II Terminated Potential for tampon to come apart upon removal. 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,…
      Full distribution text 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.
      Submission number: K112635
    • 11 Dec 2018 Z-0751-2019 Class II Terminated Potential for tampon to come apart upon removal. 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,…
      Full distribution text 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.
      Submission number: K112635

  • 2013

    • 29 Oct 2013 Z-0850-2014 Class II Terminated Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label. Distribution: US Distribution in states of: AZ, CA, DE, FL, LA, MD, MA, NJ, NY, OH, PA and TX. Submission number: K972846
    • 24 Oct 2013 Z-0518-2014 Class II Terminated Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD) because the product may stall or stick when traveling within the barrel of the syringe. Distribution: U.S. Nationwide Distribution Submission number: K941153
    • 6 Mar 2013 Z-0995-2013 Class II Terminated Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. Distribution: Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD,…
      Full distribution text Worldwide Distribution -- USA, including the states of AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, Belgium, Hong Kong, Japan, Portugal, and Singapore.
      Submission number: K881471

  • 2012

    • 5 Jul 2012 Z-0257-2013 Class II Terminated Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. Distribution: Nationwide Distribution Submission numbers: K103406, K842115
    • 5 Jul 2012 Z-0258-2013 Class II Terminated Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. Distribution: Nationwide Distribution Submission number: K103406
    • 27 Apr 2012 Z-2181-2012 Class II Terminated A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke. Distribution: Nationwide Distribution-including the states of AZ, CA, CO, DE, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, MD, ME, MO, MS,…
      Full distribution text Nationwide Distribution-including the states of AZ, CA, CO, DE, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, MD, ME, MO, MS, NE, NM, OH, OR, PA, RI, SC, TN, TX, VA, WI and WV.
      Submission number: K033021
Show the 25 most recent of 35 recalls

  • 2011

    • 21 Dec 2011 Z-0938-2012 Unclassified (pre-2012) Terminated The product is misbranded, i.e. the Gastric (center) port may be mislabeled as the Jejunal port, and the Jejunal (side) port mislabeled as the Gastric port. Distribution: Worldwide Distribution-USA (nationwide) including the states of CA, CO, ID, IL, MD, MO, NC, NJ, NY, PA, SC, UT, VA, WA,…
      Full distribution text Worldwide Distribution-USA (nationwide) including the states of CA, CO, ID, IL, MD, MO, NC, NJ, NY, PA, SC, UT, VA, WA, WI, and WV and the country of Canada.
      Submission number: K852707
    • 3 Nov 2011 Z-0393-2012 Unclassified (pre-2012) Terminated A limited number of Kotex Natural Balance Security Unscented Tampons, regular absorbency, are being recalled after a raw material contaminated with a bacterium, Enterobacter sakazakii, was found when testing the plunger portion of the applicator. Distribution: Nationwide Distribution Submission number: K896994
    • 6 Jun 2011 Z-2836-2011 Unclassified (pre-2012) Terminated Metal shavings were found within the folded portion of the surgical drape. Distribution: Nationwide (USA) distribution, including the states of CA, FL, GA, IA, IL, MO, NC, NY, OH, TN, TX, VA and WI.

  • 2010

    • 31 Dec 2010 Z-2425-2012 Class III Terminated The impacted product was not intended for commercial distribution to end users. Distribution: US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.
    • 23 Dec 2010 Z-0920-2011 Unclassified (pre-2012) Terminated Product was not properly sterilized. Distribution: Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX.
    • 23 Dec 2010 Z-0921-2011 Unclassified (pre-2012) Terminated Product was not properly sterilized. Distribution: Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX.
    • 16 Sep 2010 Z-0451-2013 Class II Terminated Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately. Distribution: Nationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE,…
      Full distribution text Nationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE, NJ, NM, NV, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, and WI
      Submission number: K033021
    • 22 Jun 2010 Z-2415-2012 Class II Terminated The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube. Distribution: Nationwide Distribution including AL, AK, AZ, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, ME, MA, MI, MN, MS,…
      Full distribution text Nationwide Distribution including AL, AK, AZ, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, ME, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
    • 22 Jun 2010 Z-2416-2012 Class II Terminated The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube. Distribution: Nationwide Distribution including AL, AK, AZ, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, ME, MA, MI, MN, MS,…
      Full distribution text Nationwide Distribution including AL, AK, AZ, CA, CO, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, ME, MA, MI, MN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.

  • 2009

    • 17 Sep 2009 Z-2017-2012 Class II Terminated Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns. Distribution: Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA Submission number: K091357
    • 17 Sep 2009 Z-2018-2012 Class II Terminated Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns. Distribution: Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA Submission number: K091357
    • 30 Apr 2009 Z-1645-2009 Unclassified (pre-2012) Terminated The product may contain defects/holes reducing the product's effectiveness as a barrier. Distribution: Nationwide Distribution -- USA including states of CT, MA, MD, NJ, and NY. Submission number: K992821

  • 2007

    • 4 Jun 2007 Z-1143-2007 Unclassified (pre-2012) Terminated The tubes may kink during use which may impede or prevent ventilation. Distribution: Worldwide, including USA, Canada, Europe, Australia, Chile, Hong Kong, Singapore, Thailand, India, Malaysia and Saudi…
      Full distribution text Worldwide, including USA, Canada, Europe, Australia, Chile, Hong Kong, Singapore, Thailand, India, Malaysia and Saudi Arabia.
      Submission number: K050803
    • 4 Jun 2007 Z-1144-2007 Unclassified (pre-2012) Terminated The tubes may kink during use which may impede or prevent ventilation. Distribution: Worldwide, including USA, Canada, Europe, Australia, Chile, Hong Kong, Singapore, Thailand, India, Malaysia and Saudi…
      Full distribution text Worldwide, including USA, Canada, Europe, Australia, Chile, Hong Kong, Singapore, Thailand, India, Malaysia and Saudi Arabia.
      Submission number: K050803

  • 2006

    • 18 May 2006 Z-1241-06 Unclassified (pre-2012) Terminated The tinfoil in the triangle electrodes has the potential to develop cracks which may hinder electrical flow and product performance during defibrillation. Distribution: Worldwide ( including USA, Switzerland, Germany, UK, Canada, Australia, Netherlands, Italy, Greece, Spain, Hong Kong,…
      Full distribution text Worldwide ( including USA, Switzerland, Germany, UK, Canada, Australia, Netherlands, Italy, Greece, Spain, Hong Kong, Hungary, Denmark, Singapore, New Zealand, Ireland, Korea)
      Submission number: K895729

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Kimberly-Clark Inc. Mississauga Ontario · CA FEI 1000312280

Frequently asked questions

How many devices does KIMBERLY-CLARK CORPORATION have in the registry?

The registry currently lists 122 devices for KIMBERLY-CLARK CORPORATION. Devices recorded under merged duplicate company entries are counted once.

Which registries list KIMBERLY-CLARK CORPORATION's devices?

Among its 50 most recently registered devices, KIMBERLY-CLARK CORPORATION has devices listed in FDA 510(k) (50 devices).

What risk classes do KIMBERLY-CLARK CORPORATION's devices fall under?

Among its 50 most recently registered devices, the classes recorded for KIMBERLY-CLARK CORPORATION's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for KIMBERLY-CLARK CORPORATION?

FDA recall records list 35 recalls initiated by KIMBERLY-CLARK CORPORATION, the most recent initiated on 2018-12-11. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from KIMBERLY-CLARK CORPORATION in the registry?

The most recently registered devices listed for KIMBERLY-CLARK CORPORATION include KIMBERLY-CLARK CHILD'S FACEMASK, KOTEX PROFILE SHAPED MAXI PAD, KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION and KOTEX SECURITY TUBE TAMPONS.

Which FDA establishments are linked to KIMBERLY-CLARK CORPORATION?

1 FDA establishment is linked to KIMBERLY-CLARK CORPORATION in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.