Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall nanoDot D2DNS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall nanoDot D2DNN LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; radiation… LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation… LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Calibrate (Cs-137) nanoDot D2DNS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring… LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiation monitoring… LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall QC (Cs-137) nanoDot D2DNS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Calibrate (unexposed) nanoDot D2DNS LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT;… LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Constancy (Cs-137) nanoDot D2DNN LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, description: nanoDot… LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Reader, nanoDot adapter, EU LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusCompletedWhereNo state named
- Medical device recall KWIK-STIK, ANA One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis. Class IIIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 20, 2023ClassClass IIIStatusOngoingWhereNationwide, and Minnesota, Pennsylvania, Tennessee and Texas named
- Medical device recall BeamAdjust software Version 2.3.3 Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a… Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for… Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Keystone Bosworth Copaliner Cavity Varnish .5oz A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526). Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Nevada, Pennsylvania and Texas named
- Medical device recall Welch Allyn Connex Spot Monitor Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall ACUSON Redwood 2.0 ultrasound systems If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will… Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Florida, Iowa, Illinois, Indiana, Louisiana, Maryland, Maine, Michigan, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Texas, Virginia and Wisconsin named
- Medical device recall Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible. Class IIFDA’s classSep 20, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal… Class IIFDA’s classSep 20, 2023in FDA’s Enforcement Report53 statesnamed in where it went PublishedSep 20, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Allura Xper series A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MultiDiagnost-Eleva A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of… Sterility of device may be compromised due to breach of the chevron seal of the packaging Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ISee Ortho-K Lens Manufactured lenses are not covered by existing FDA approval Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Fargo Ortho-K Lens Manufactured lenses are not covered by existing FDA approval Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose… Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedSep 13, 2023ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall For intraventricular indications mainly used for operations within the brain ventricles Trocar manufactured with the shaft too long and does not meet manufacturing specifications. Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Idaho, Illinois, Maryland, North Carolina, New York, Oregon, Rhode Island and Texas named
- Medical device recall M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6… The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa. Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 13, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Georgia, Michigan, New Jersey, Pennsylvania, Tennessee and Wisconsin named
- Medical device recall ZVU Functional GI Software GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. Class IIIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 13, 2023ClassClass IIIStatusOngoingWhereNationwide, and Colorado, Florida, Georgia, Kansas, Kentucky, Minnesota, New Jersey, New York, Oregon, Tennessee, Texas and Washington named
- Medical device recall Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the… The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US),… The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 Class IIFDA’s classSep 13, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 13, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol… Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in… Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of… Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in… Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) Users were reporting that the device was not charging as expected. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Users were reporting that the device was not charging as expected. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) Users reported “System Over Temperature” alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Users reported “System Over Temperature” alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) Users were reporting instances of “Gas Loss in IAB Circuit” and “Gas Gain in IAB Circuit” alarms while providing therapy. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Users were reporting instances of “Gas Loss in IAB Circuit” and “Gas Gain in IAB Circuit” alarms while providing therapy. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) Users were identifying autofill failure conditions on the devices causing pump stops. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Users were identifying autofill failure conditions on the devices causing pump stops. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of… Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type Class IIFDA’s classSep 6, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 6, 2023ClassClass IIStatusOngoingWhereNationwide
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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