RegWardenFDA facility compliance records
Company

KIMBERLY-CLARK CORPORATION

9 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2009: 1 recalls; 2010: 3 recalls; 2012: 2 recalls; 2013: 3 recalls1’093’10’112’123’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (9)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2013-10-29
    Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
  • Class IITerminated2013-10-24
    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.
  • Class IITerminated2013-03-06
    Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
  • Class IITerminated2012-07-05
    Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
  • Class IITerminated2012-04-27
    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.
  • Class IIITerminated2010-12-31
    The impacted product was not intended for commercial distribution to end users.
  • Class IITerminated2010-09-16
    Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
  • Class IITerminated2010-06-22
    The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
  • Class IITerminated2009-09-17
    Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “KIMBERLY-CLARK CORPORATION — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10028842-kimberly-clark-corporation/

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