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 |
|---|---|---|---|---|
| Oct 10, 2013 | Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactat... | Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell le... | Class II | Nova Biomedical Corporation |
| Sep 12, 2013 | MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manuf... | It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device ma... | Class II | Maquet Medical Systems USA |
| Aug 29, 2013 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... | The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... | Class II | Boston Scientific CRM Corp |
| Aug 29, 2013 | Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... | The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... | Class II | Boston Scientific CRM Corp |
| Aug 28, 2013 | *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; **... | Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the corr... | Class II | Hospira Inc. |
| Jul 16, 2013 | ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store ... | The products may have been stored at temperatures outside their required storage conditions. | Class II | Assuramed |
| Jul 16, 2013 | Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (... | Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. ... | Class III | Zoll Circulation, Inc. |
| Jun 4, 2013 | ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system t... | Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complem... | Class II | Baxa Corporation |
| Jun 3, 2013 | Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, ... | Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... | Class I | Medtronic Neuromodulation |
| Jun 3, 2013 | Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 2... | Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient m... | Class I | Medtronic Neuromodulation |
| May 28, 2013 | VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System... | DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlo... | Class II | DJO, LLC |
| Apr 24, 2013 | embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilato... | Calibration error for Embla Embletta Gold units calibrated through service center between June 15... | Class II | Embla System Llc |
| Apr 10, 2013 | Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M,... | Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of e... | Class II | Philips Medical Systems, Inc. |
| Apr 5, 2013 | Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batterie... | Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instrumen... | Class I | Newport Medical Instruments Inc |
| Mar 21, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medica... | Class II | Hospira Inc. |
| Mar 21, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medica... | Class II | Hospira Inc. |
| Mar 18, 2013 | GemStar Pump - Battery Product Usage: The GemStar Pump is a small and li... | Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview th... | Class I | Hospira Inc. |
| Mar 18, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | Pump shutting off during use without warning. | Class I | Hospira Inc. |
| Mar 18, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | Pump shutting off during use without warning. | Class I | Hospira Inc. |
| Mar 18, 2013 | GemStar Pump - Battery Product Usage: The GemStar Pump is a small and ... | Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview th... | Class I | Hospira Inc. |
| Mar 15, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | The proximal and distal pressure sensor calibration can drift resulting in the pump failing the P... | Class I | Hospira Inc. |
| Mar 15, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | The proximal and distal pressure sensor calibration can drift resulting in the pump failing the P... | Class I | Hospira Inc. |
| Mar 7, 2013 | Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator s... | When using the SERVO-i on battery power, in a very small number of cases, some battery modules di... | Class I | Maquet Cardiovascular Us Sales, Llc |
| Feb 8, 2013 | The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbe... | LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to t... | Class II | Physio Control, Inc. |
| Feb 5, 2013 | Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... | Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pu... | Class II | Hospira Inc. |
| Feb 5, 2013 | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... | Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pu... | Class II | Hospira Inc. |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Feb 1, 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provid... | A possible interruption of therapy when an E321 error code occurs while using the infuser, which ... | Class II | ICU |
| Jan 31, 2013 | Century Console Base, Model #043625051b. Intended for use as a platform ... | Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not co... | Class II | Salyer Prn Biomedical |
| Jan 14, 2013 | P10 Tobii battery box (product number 510410) Product Usage - Battery pack... | Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunc... | Class II | Tobii Assistive Technology, Inc. |
| Jan 14, 2013 | Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400.... | Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, i... | Class II | Oxus America, Inc. |
| Dec 5, 2012 | Companion External Battery, Part Number: 293001-001 The Companion External... | Syncardia Systems is recalling the Companion External Batteries used with the Companion 2 Driver ... | Class II | SynCardia Systems Inc. |
| Dec 5, 2012 | Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... | B. Braun Medical Inc. is informing our customers of a field correction previously performed to ad... | Class II | B Braun Medical, Inc. |
| Nov 30, 2012 | Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 371... | There is issues of warmth or heating at the implant site during charging for the Eon Mini implant... | Class II | St. Jude Medical |
| Nov 14, 2012 | 100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced... | Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a... | Class II | Terumo Cardiovascular Systems Corporation |
| Nov 14, 2012 | 220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced... | Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced ... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 26, 2012 | BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold... | Battery may over-heat during charging and smoke | Class II | iwalk inc |
| Oct 25, 2012 | The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorpor... | Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to p... | Class I | Verathon, Inc. |
| Oct 19, 2012 | qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 ... | Spacelabs Healthcare has learned through several reports that the input circuit may fail and the... | Class II | Spacelabs Healthcare, Llc |
| Oct 15, 2012 | The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee d... | OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal... | Class II | Ossur Americas, Inc. |
| Sep 28, 2012 | Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pr... | Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothro... | Class II | International Technidyne Corp. |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The ... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... | Class II | Terumo Cardiovascular Systems Corporation |
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.