Kimberly-Clark Corporation

Complete recall history across all FDA and CPSC categories — 19 total recalls

Kimberly-Clark Corporation appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (3)

FDA drug safety enforcement actions by Kimberly-Clark Corporation

Date Product Reason Class
Feb 1, 2021 Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed... Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are i... Class II
Jun 14, 2012 Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl o... Microbial Contamination of Non-Sterile Products; The affected lots were found... Class II
Jun 14, 2012 Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Lit... Microbial Contamination of Non-Sterile Products; The affected lots were found... Class II

Device Recalls (16)

FDA medical device enforcement actions by Kimberly-Clark Corporation

Date Product Reason Class
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular Tampons, 34 Count Potential for tampon to come apart upon removal. Class II
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack Potential for tampon to come apart upon removal. Class II
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular Tampons, 18 Count Potential for tampon to come apart upon removal. Class II
Dec 11, 2018 U by Kotex¿ Sleek¿, Regular Tampons, 3 Count Potential for tampon to come apart upon removal. Class II
Oct 29, 2013 Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Ac... Product may contain a cannula with an active tip length of only 5mm rather th... Class II
Oct 24, 2013 Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD L... Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL... Class II
Mar 6, 2013 KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm)... Some individual container filter units might contain thin areas that may pote... Class II
Jul 5, 2012 ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a ste... Package seam of some units may not remain properly sealed to ensure the conte... Class II
Jul 5, 2012 MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product... Package seam of some units may not remain properly sealed to ensure the conte... Class II
Apr 27, 2012 Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly... A defect of the "fuse holder" can lead to a Control Unit failure that may cau... Class II
Dec 31, 2010 ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Ki... The impacted product was not intended for commercial distribution to end users. Class III
Sep 16, 2010 Kimberly-Clark Patient Warming System - Model 1000 Control Unit The produc... Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inap... Class II
Jun 22, 2010 Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - P... The placement guidewire diameter is too large and does not pass-through the i... Class II
Jun 22, 2010 Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG K... The placement guidewire diameter is too large and does not pass-through the i... Class II
Sep 17, 2009 MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-L... Complaints were received of gowns pilling or balling, linting and abrades, bl... Class II
Sep 17, 2009 MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, ... Complaints were received of gowns pilling or balling, linting and abrades, bl... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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