Browse Device Recalls
740 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 740 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 740 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 12, 2016 | Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 | CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may ca... | Class II | CareFusion 303, Inc. |
| Feb 4, 2016 | Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation. | The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation C... | Class I | Draeger Medical, Inc. |
| Jan 15, 2016 | Universal Battery Charger II (UBC II) | The device is reported to enter safe mode and is no longer able to charge batteries. | Class II | The Anspach Effort, Inc. |
| Jan 13, 2016 | Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily... | Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. | Class II | Resmed Corporation |
| Jan 7, 2016 | HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, ... | Heartware Ventricular Assist System Battery Cell experiencing premature depletion. | Class I | Heartware, Inc. |
| Dec 23, 2015 | Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power ... | The sterile battery may contain particulates within the sterile package. | Class II | Pro-Dex Inc |
| Dec 23, 2015 | Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS ... | The sterile battery may contain particulates within the sterile package. | Class II | Pro-Dex Inc |
| Dec 21, 2015 | Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Dens... | A possible malfunction where a Short-term Battery Error message has appeared and has been traced ... | Class II | Fukuda Denshi USA, Inc. |
| Dec 1, 2015 | Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN... | The firm became aware of cases in which the battery run times of the optional PS 500 power supply... | Class I | Draeger Medical, Inc. |
| Nov 25, 2015 | Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Ansp... | Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, R... | Class II | The Anspach Effort, Inc. |
| Nov 18, 2015 | Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 | Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartb... | Class II | Cyberonics, Inc |
| Nov 10, 2015 | MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The Med... | A small number of specific pumps may trigger a low battery alarm at the beginning of the implante... | Class II | Codman & Shurtleff, Inc. |
| Nov 10, 2015 | Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trig... | The firm identified a malfunction which made it possible for a handpiece to start by itself when ... | Class II | Zimmer, Inc. |
| Nov 10, 2015 | MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The Med... | A small number of specific pumps may trigger a low battery alarm at the beginning of the implante... | Class II | Codman & Shurtleff, Inc. |
| Nov 10, 2015 | Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trig... | The firm identified a malfunction which made it possible for a handpiece to start by itself when ... | Class II | Zimmer, Inc. |
| Nov 9, 2015 | Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The pr... | The product may contain electronic components that lead to a premature drainage of the internal c... | Class II | C.R. Bard, Inc. |
| Nov 9, 2015 | Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generat... | Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term batte... | Class II | Medtronic Inc. |
| Oct 7, 2015 | Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 | Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartb... | Class II | Cyberonics, Inc |
| Sep 3, 2015 | Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80... | When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and i... | Class II | Spacelabs Healthcare Inc |
| Jul 23, 2015 | Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response Sy... | Irregular battery disconnection resulted in issues with Mobile Health Button (MHB) Charging. | Class II | Lifeline Systems, Incorporated |
| Jul 13, 2015 | PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended fo... | The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V... | Class I | Draeger Medical, Inc. |
| Jul 1, 2015 | Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical p... | Saw head separated from the drive unit or began to come loose. | Class II | The Anspach Effort, Inc. |
| May 1, 2015 | 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Pe... | Terumo CVS is implementing field correction activities to address the identified causes of the Te... | Class II | Terumo Cardiovascular Systems Corporation |
| May 1, 2015 | Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Pe... | Terumo CVS is implementing field correction activities to address the identified causes of the Te... | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 29, 2015 | HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 ... | Complaints with the HVAD Internal Controller Alarm Battery failures. | Class I | HeartWare Inc |
| Apr 13, 2015 | GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5... | Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibil... | Class II | Verathon, Inc. |
| Mar 25, 2015 | Universal Charger Product Usage: The Stryker Universal Battery Charg... | The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as desi... | Class III | Stryker Instruments Div. of Stryker Corporation |
| Mar 24, 2015 | Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532... | The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive... | Class II | The Anspach Effort, Inc. |
| Mar 17, 2015 | Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product... | Possible performance issue when used with specific AA-sized (LR6) batteries. The negative termina... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Mar 16, 2015 | Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 ... | Battery packs may heat up abnormally and ignite in rare instance. | Class II | Arcos, Inc |
| Mar 10, 2015 | FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MO... | This recall is being conducted because a cohesive band used to package the devices contains latex... | Class II | Microtek Medical Inc |
| Mar 6, 2015 | Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devi... | 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 | Precedence 6 (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 TF (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 X (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 | CardioMD III (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 | Diamond Select Brilliance CT 16 (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 | GEMINI TF PET/CT 16 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 | Brilliance CT 40 - Slices (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 | 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 | 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 | 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 | 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 | 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 |
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.