Browse Device Recalls
59 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 59 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 59 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 8, 2019 | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... | The connector piece to the PEG tube does not pass over the guidewire. | Class II | Avanos Medical, Inc. |
| Oct 8, 2019 | CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG... | The connector piece to the PEG tube does not pass over the guidewire. | Class II | Avanos Medical, Inc. |
| 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 10, 2016 | Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile. | Defects: Product may be discolored and brittle resulting in the inability of the user to don the ... | Class II | Halyard Health |
| 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 |
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.