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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.