Browse Device Recalls

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

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DateProductReasonClassFirm
Jan 14, 2015 AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier ... The packages may contain foreign material (black particles). Class II Teleflex Medical
Jan 14, 2015 Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery s... Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certa... Class II INO Therapeutics (dba Ikaria)
Jan 14, 2015 AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier ... The packages may contain foreign material (black particles). Class II Teleflex Medical
Jan 14, 2015 AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier A... The packages may contain foreign material (black particles). Class II Teleflex Medical
Jan 14, 2015 ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an acces... The packages may contain foreign material (black particles). Class II Teleflex Medical
Jan 14, 2015 AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier A... The packages may contain foreign material (black particles). Class II Teleflex Medical
Jan 14, 2015 AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is ... The packages may contain foreign material (black particles). Class II Teleflex Medical
Jan 14, 2015 Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Pla... Potential for failure of the pouch packaging seal at high altitudes. Class II Baxter Healthcare Corp.
Jan 14, 2015 AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifi... The packages may contain foreign material (black particles). Class II Teleflex Medical
Jan 14, 2015 AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier ... The packages may contain foreign material (black particles). Class II Teleflex Medical
Jan 14, 2015 AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier ... The packages may contain foreign material (black particles). Class II Teleflex Medical
Jan 13, 2015 Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PAC... In case of a system crash, images may not be written to the hard disk and this may result in inco... Class II Siemens Medical Solutions USA, Inc
Jan 13, 2015 GE Inspection Technologies x|argos 160D system. Cabinet x-ray system. It was discovered that the upper left corner-shaped lead shield in the window in one of the doors... Class II GE Inspection Technologies, LP
Jan 13, 2015 cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA a... False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mu... Class III Roche Molecular Systems, Inc.
Jan 13, 2015 ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 70... The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder. Class II Med-logics Inc
Jan 13, 2015 SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusio... CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage i... Class II CareFusion 303, Inc.
Jan 13, 2015 GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system It was discovered that the upper left corner-shaped lead shield in the window in one of the doors... Class II GE Inspection Technologies, LP
Jan 13, 2015 Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medica... Tthe medical monitor has either not turned on or has lost image during clinical use. Class II Sony Medical Systems
Jan 13, 2015 LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, ... The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New... Class II Teleflex Medical
Jan 13, 2015 KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A,... The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument... Class II Medtronic Sofamor Danek USA Inc
Jan 12, 2015 MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01... Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm I... Class I Teleflex Medical
Jan 12, 2015 Servo-I ventilator system CO2 analyzer. Part number 65 23 588. A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 anal... Class II Maquet Cardiovascular Us Sales, Llc
Jan 12, 2015 ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. ... There is a low probability the scanner arm will become completely detached from the scanner column. Class II Siemens Medical Solutions USA, Inc.
Jan 12, 2015 ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. ... The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Cont... Class II Siemens Medical Solutions USA, Inc.
Jan 12, 2015 Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxx... Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occas... Class II Covidien LP (formerly Nellcor Puritan Bennett I...
Jan 9, 2015 NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 6010... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog N... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H965601206511, REF/Catalog No. 60120651, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965P... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog N... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601907851, REF/Catalog No. 60190785, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No.... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600416321, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 6... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body. The MRI system safety feature, which lowers the magnetic field in emergency situations, may not w... Class I Alltech Medical Systems America Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H965PK193168S1, REF/Catalog No. PK193168S, STERILE... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602000571, REF/Catalog No. 602... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H965601017731, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601801561, REF/Catalog No. 60180156, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operatin... Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon us... Class III Alivecor SFO

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.