Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
Jul 17, 2017 CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle ... False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... Class I Maquet Datascope Corp - Cardiac Assist Division
Jul 17, 2017 CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... Class I Maquet Datascope Corp - Cardiac Assist Division
Jul 12, 2017 MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 ... Affected units may have a defective component that is intended to protect the internal circuitry ... Class I Philips North America, LLC
Jun 16, 2017 CS 300 Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... Class I Maquet Datascope Corp - Cardiac Assist Division
Jun 16, 2017 CS 100i Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... Class I Maquet Datascope Corp - Cardiac Assist Division
Jun 16, 2017 CS 100 Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... Class I Maquet Datascope Corp - Cardiac Assist Division
Jun 9, 2017 Penumbra 3D Revascularization Device It is indicated for used in the revascu... Penumbra has identified an issue in these four lots involving a raw material component of the del... Class I Penumbra Inc.
Jun 2, 2017 St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Cur... Inadequate seal due to lack of adhesive glue Class I Sterilmed Inc
May 23, 2017 Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: ... Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... Class I Magellan Diagnostics, Inc.
May 23, 2017 Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product U... Underestimates the lead concentration of venous blood samples when the sample is analyzed with th... Class I Magellan Diagnostics, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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 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, 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 26, 2017 Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb ... Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System... Class I Abbott Vascular
Apr 25, 2017 Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS... Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a pot... Class I Vascular Solutions, Inc.
Apr 24, 2017 Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053... Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor... Class I Respironics California Inc
Apr 20, 2017 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion a... Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Im... Class I EBI Patient Care, Inc.
Apr 20, 2017 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal f... Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Im... Class I EBI Patient Care, 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.