Browse Device Recalls
723 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 723 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 723 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Sep 25, 2012 | Perfusion System 8000, base 4 pump, 115V 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 5 pump, 115V 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 5 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 5 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 |
| Sep 25, 2012 | Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centr... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various m... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 25, 2012 | Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifug... | Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various m... | Class II | Terumo Cardiovascular Systems Corporation |
| Sep 11, 2012 | Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A bat... | HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with ... | Class II | Philips Healthcare Inc. |
| Sep 4, 2012 | The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable,... | Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimu... | Class II | Advanced Neuromodulation Systems Inc. |
| Aug 8, 2012 | Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 1... | Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 26, 2012 | Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the mana... | As part of St. Jude Medical's routine tracking and product monitoring, they have received a total... | Class II | St. Jude Medical |
| Jul 6, 2012 | Finapres Medical Systems Portapres with NiMh battery pack Product Usage:... | Battery may become hot and leak | Class II | FMS, Finapres Medical Systems BV |
| Jun 27, 2012 | Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m... | Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... | Class II | Stryker Medical Division of Stryker Corporation |
| Jun 27, 2012 | Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m... | Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... | Class II | Stryker Medical Division of Stryker Corporation |
| Jun 27, 2012 | Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo... | Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... | Class II | Stryker Medical Division of Stryker Corporation |
| Jun 27, 2012 | Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo... | Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... | Class II | Stryker Medical Division of Stryker Corporation |
| Jun 22, 2012 | System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicat... | Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during p... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 22, 2012 | System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated... | Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during p... | 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.