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.

Clear
DateProductReasonClassFirm
Mar 6, 2015 Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Com... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogr... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supp... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Com... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. ... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L.... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedi... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Gener... The pulse generators have a lower battery longevity than specified in their design requirement as... Class II Cyberonics, Inc
Mar 6, 2015 CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Comput... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Compute... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessor... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomograp... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory device... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and blood... Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate i... Class II Nidek Inc
Mar 6, 2015 Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory device... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed ... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Compu... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accesso... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogra... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) C... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Compute... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Compute... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 CROSSCHECK(R) Plating system, Y-PLATE CX, REF CCP-YPX1. Orthopedic use. The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostic... The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20... Class II BD Biosciences, Systems & Reagents
Mar 6, 2015 Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Compute... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthope... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devic... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Comp... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthope... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Com... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 ExacTrac 6.x. is software used to place patients at an accurately defined poi... ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the... Class II Brainlab AG
Mar 6, 2015 CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. ... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. O... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthope... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthoped... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) C... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devic... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) C... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2015 CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Or... The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, Inc.
Mar 6, 2015 MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed T... The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... Class II Philips Medical Systems (Cleveland) Inc
Mar 5, 2015 Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are conti... The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... Class II Siemens Medical Solutions Diagnostics
Mar 5, 2015 HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Produc... A potential issue was detected that could result in blood leakage from the gas outlet port in all... Class II Maquet Cardiovascular Us Sales, Llc
Mar 5, 2015 Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox... A potential issue was detected that could result in blood leakage from the gas outlet port in all... Class II Maquet Cardiovascular Us Sales, 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.