Halyard Health, Inc

Complete recall history across all FDA and CPSC categories — 48 total recalls

Halyard Health, Inc 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 (48)

FDA medical device enforcement actions by Halyard Health, Inc

Date Product Reason Class
Feb 7, 2018 Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to ... Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex C... Class II
Feb 7, 2018 Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿Sy... Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex C... Class II
Feb 7, 2018 Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿Syst... Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex C... Class II
Dec 13, 2017 CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagne... The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) ... Class II
Oct 6, 2017 Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 via... Received recall notification from Smiths Medical that lots of 15ml Saline Via... Class II
Oct 6, 2017 Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. ... Received recall notification from Smiths Medical that lots of 15ml Saline Via... Class II
Oct 6, 2017 Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet ... Received recall notification from Smiths Medical that lots of 15ml Saline Via... Class II
Oct 6, 2017 NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD... Received recall notification from Smiths Medical that lots of 15ml Saline Via... Class II
Oct 6, 2017 Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet P... Received recall notification from Smiths Medical that lots of 15ml Saline Via... Class II
Oct 6, 2017 Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet P... Received recall notification from Smiths Medical that lots of 15ml Saline Via... Class II
Oct 6, 2017 Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 ... Received recall notification from Smiths Medical that lots of 15ml Saline Via... Class II
Oct 6, 2017 Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials p... Received recall notification from Smiths Medical that lots of 15ml Saline Via... Class II
Oct 6, 2017 Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 via... Received recall notification from Smiths Medical that lots of 15ml Saline Via... Class II
Nov 9, 2016 Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Prod... Drapes within the affected lots may include a manufacturing variation that pr... Class II
Jun 16, 2016 Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conj... Mismatch between the length of the RF electrode (probe) and the cannula (intr... Class II
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece  MDI Ad... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Produc... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Produc... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Produ... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional T... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 1... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155);... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheos... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 227... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109)... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DS... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product ... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Pro... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Prod... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Co... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product C... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Prod... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); Ki... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product ... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); Kim... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Prod... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Jul 29, 2015 NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, D... The thumb valve of some KIMVENT Closed Suction Systems remained partially ope... Class II
Apr 14, 2015 KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Produc... The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suct... 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.

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