Browse Device Recalls

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

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DateProductReasonClassFirm
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
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Si... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Si... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only.... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use O... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx ... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only.... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Sin... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use On... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use O... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use O... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For S... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC
Apr 21, 2017 Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single U... Product's seal possibly compromised, potentially compromising the sterility of the package conten... Class II Cardinal Health 200, LLC

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.