Halyard Health

Complete recall history across all FDA and CPSC categories — 9 total recalls

Halyard Health appears in recall records across 1 category. 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.

Device Recalls (9)

FDA medical device enforcement actions by Halyard Health

Date Product Reason Class
Nov 10, 2016 Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile. Defects: Product may be discolored and brittle resulting in the inability of ... Class II
Jan 16, 2015 KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr... Defect: A hole or crack was found which may cause air to leak. Class II
Jan 16, 2015 KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile... Defect: A hole or crack was found which may cause air to leak. Class II
Jan 16, 2015 KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Steril... Defect: A hole or crack was found which may cause air to leak. Class II
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I
Nov 17, 2014 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distribut... The cuff inflation line may detach from the endotracheal tube during use. Class I

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.

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