Browse Device Recalls
63 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 63 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 63 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 10, 2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... | Class I | Vyaire Medical |
| Apr 10, 2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... | Class I | Vyaire Medical |
| Apr 8, 2024 | Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-7073... | Potential of the nozzle separating during patient use. | Class I | Vyaire Medical, Inc. |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, withou... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, R... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Dete... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, A... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Jan 10, 2024 | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult ... | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooli... | Class I | Vyaire Medical |
| Oct 27, 2023 | vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used wi... | Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator... | Class II | Vyaire Medical |
| Oct 27, 2023 | vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used wi... | Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator... | Class II | Vyaire Medical |
| May 5, 2023 | bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Vent... | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell... | Class II | Vyaire Medical |
| May 5, 2023 | bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ven... | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bell... | Class II | Vyaire Medical |
| Dec 20, 2021 | bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventila... | Potential cessation in ventilation can occur under specific conditions. | Class I | Vyaire Medical |
| Nov 25, 2019 | bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an ele... | The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic hig... | Class II | Vyaire Medical |
| Mar 13, 2019 | enFlow Disposable Cartridge with IV Extension Set, used for intravenous warmi... | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warm... | Class I | Vyaire Medical |
| Mar 13, 2019 | enFlow Disposable Cartridge, used for intravenous warming therapy with fluid ... | Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. | Class I | Vyaire Medical |
| Jun 20, 2018 | The Tri-Flo Subglottic Suction System | Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Sub... | Class I | Vyaire Medical |
| May 8, 2018 | AirLife Resuscitation Device, Pediatric labeled as the following: a. Ped... | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... | Class I | Vyaire Medical |
| May 8, 2018 | AirLife Resuscitation Device, Adult labeled as the following: a. Adult, ... | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... | Class I | Vyaire Medical |
| Jul 18, 2017 | AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE ... | Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect... | Class II | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usag... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Prod... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filt... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-r... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressu... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pr... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-r... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-reli... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Res... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Res... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 28inch large bore tubing Product ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer,... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEE... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Replacement kit for outer shell, Broselow Product U... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
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.