Browse Device Recalls
3,306 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,306 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 3,306 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 21, 2017 | PALLAS M/MAXIMIS 50mm Curved and precontoured Rod. Part of MAXIMIS Pedicle Sc... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 5.5 x 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal ... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 40mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS Body Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal ... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fi... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 21, 2017 | PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixat... | Devices are not consistent with Quality System Requirements. | Class II | Valorem Surgical LLC |
| Jun 19, 2017 | Nussloch GmbH ASP6025 Tissue Processor | Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. | Class II | Leica Microsystems, Inc. |
| Jun 15, 2017 | Plum 360 Infusion System | Potential for the Connectivity Engine Module of the affected unit to disengage from the main chas... | Class II | ICU Medical Inc |
| Jun 14, 2017 | ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used ... | Reports of the device failure involving delivering continuous pressure to the calf garment and no... | Class II | Arjo, Inc. dba ArjoHuntleigh |
| May 24, 2017 | Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used wi... | The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. Acc... | Class II | Northgate Technologies, Inc. |
| 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 | AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | PEG kits have the potential for one of the following defects: missing components, duplicate compo... | Class II | AbbVie Inc. |
| 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 | AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | Class II | AbbVie Inc. | |
| Apr 27, 2017 | AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | PEG kits have the potential for one of the following defects: missing components, duplicate compo... | Class II | AbbVie Inc. |
| 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 |
| 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, 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, 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, Adult, with mask, 28inch large bore tubing, 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, Adult, with mask, oxygen reservoir bag, manometer P... | 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, 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 |
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.