Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System,… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System,… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System,… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System,… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic… The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA)… May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Tennessee and Texas named
- Medical device recall ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA)… May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNationwide, and Tennessee and Texas named
- Medical device recall CURAD REUSABLE GEL HOT/COLD PACK The product contains natural rubber latex but the label states that it does not. Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available… Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto… Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient… Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 16, 2022ClassClass IIStatusOngoingWhereNationwide, and Colorado, Connecticut, Florida, Massachusetts, Maryland, Oregon, Pennsylvania and Wisconsin named
- Medical device recall KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. Class IIIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall LYSO Disk(TM) labeled as containing Actinomyces odontolyticus Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. Class IIIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall CovClear COVID-19 Rapid Antigen Test, ATG 900-031 COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IStatusCompletedWhereNationwide
- Medical device recall ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IStatusCompletedWhereNationwide
- Medical device recall Baxter Spectrum IQ Infusion Pumps There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 9, 2022ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 9, 2022ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereArkansas, Indiana, Kansas, Massachusetts, Missouri, Nebraska and West Virginia
- Medical device recall X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the… Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereCalifornia, Michigan, Nevada and Texas
- Medical device recall The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode… Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode… Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode… Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode… Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode… Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode… Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode… Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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