Browse Device Recalls

48 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 48 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 48 FDA device recalls.

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DateProductReasonClassFirm
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 Connector may become ... Class II Halyard Health, Inc
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 Connector may become ... Class II Halyard Health, Inc
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 Connector may become ... Class II Halyard Health, Inc
Dec 13, 2017 CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagne... The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with A... Class II Halyard Health, Inc
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 Vials may be susceptibl... Class II Halyard Health, Inc
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 Vials may be susceptibl... Class II Halyard Health, Inc
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 Vials may be susceptibl... Class II Halyard Health, Inc
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 Vials may be susceptibl... Class II Halyard Health, Inc
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 Vials may be susceptibl... Class II Halyard Health, Inc
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 Vials may be susceptibl... Class II Halyard Health, Inc
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 Vials may be susceptibl... Class II Halyard Health, Inc
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 Vials may be susceptibl... Class II Halyard Health, Inc
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 Vials may be susceptibl... Class II Halyard Health, Inc
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 prevents convenient re... Class II Halyard Health, Inc
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 (introducer), Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 open after suctioning w... Class II Halyard Health, Inc
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 Suction System for Adult... Class II Halyard Health, Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.