Kimberly-clark Corporation

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Tampon, Menstrual, UnscentedHEB1,234
• Tubes, Gastrointestinal (And Accessories)KNT28
• Catheters, Suction, TracheobronchialBSY16
• System, Thermal RegulatingDWJ9
• Garment, Protective, For IncontinenceEYQ8
• Mask, SurgicalFXX5
• Pad, Menstrual, UnscentedHHD5
• Drape, Surgical, AntimicrobialKKX4
• Patient Examination GloveFMC3
• Tourniquet, NonpneumaticGAX2

Recent recalls

• 2014-01-28TerminatedEmployee error

  Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.

  Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.

• 2013-12-16TerminatedComponent design/selection

  Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs

  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.

• 2013-03-26TerminatedComponent design/selection

  KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.

  Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.

• 2012-11-29TerminatedComponent design/selection

  Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.

  Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.

• 2012-11-07TerminatedPackaging process control

  ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

  Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

• 2012-11-07TerminatedPackaging process control

  MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

  Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

• 2012-09-20TerminatedNonconforming Material/Component

  Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.

  The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.

• 2012-09-20TerminatedNonconforming Material/Component

  Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.

  The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.

• 2012-09-20TerminatedPackaging process control

  ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

  The impacted product was not intended for commercial distribution to end users.

• 2012-08-09TerminatedDevice Design

  Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature.

  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.