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 Sterile surgical convenience kit: regard The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Missouri named
- Medical device recall Sterile surgical convenience kit: regard The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Missouri named
- Medical device recall Sterile surgical convenience kits: 1 The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Missouri named
- Medical device recall Sterile surgical convenience kits: 1 The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida and Missouri named
- Medical device recall GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube The product is brittle and potentially crumbling upon handling or when being removed from its package. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall VersaOne Reusable Positioning Cannula 8 mm Standard There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where… Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and North Carolina named
- Medical device recall VersaOne Reusable Positioning Cannula 11mm Standard There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where… Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and North Carolina named
- Medical device recall VersaOne Reusable Positioning Cannula 12mm Standard There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where… Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and North Carolina named
- Medical device recall stryker ORTHOLOC 3Di Fusion Plate MTP Right Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall stryker ORTHOLOC 3Di Fusion Plate MTP Right Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Mani Trocar Kit A packaging defect may compromise the sterile barrier. Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportMissourithe one state its words name PublishedMay 3, 2023ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional… Examination room monitor connected with the hybrid cable may have a display issue and no image function is available Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Puerto Rico and South Dakota named
- Medical device recall FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose… Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or… Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data… The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response… Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and… The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response… Class IIFDA’s classMay 3, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 3, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or… A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 26, 2023ClassClass IStatusOngoingWhereNationwide, 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, West Virginia and Wyoming named
- Medical device recall KLS martin Group KLS E-COUPLING ADAPTER Incorrect Unique Device Identifier/GTIN code was used on product. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, District of Columbia, Illinois, Kansas, Louisiana, Minnesota, North Carolina, New York, Oklahoma and Wisconsin named
- Medical device recall JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of… Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois, Maryland, Michigan, Mississippi, New York, Ohio, Texas, Virginia and Washington named
- Medical device recall AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you… Due to potential software issue that may result in patient mix-up information. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall GEO Instrument Kit for EPS Plate Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, Connecticut, New Jersey, Ohio and Oregon named
- Medical device recall VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data… Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD),… Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Georgia and New York named
- Medical device recall Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to… Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with… Problem maintaining the stable placement of the battery may come loose from the housing and become damaged. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MectaLIF ANTERIOR - Lag Plate Flush H10 There is a potential for breakage of the small screw used to affix the anti-backout plate. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 26, 2023ClassClass IIStatusCompletedWhereArizona, Georgia, Idaho, Texas and Virginia
- Medical device recall MectaLIF ANTERIOR - Lag Plate Flush H12 There is a potential for breakage of the small screw used to affix the anti-backout plate. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 26, 2023ClassClass IIStatusCompletedWhereArizona, Georgia, Idaho, Texas and Virginia
- Medical device recall MectaLIF ANTERIOR - Lag Plate Flush H14 There is a potential for breakage of the small screw used to affix the anti-backout plate. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 26, 2023ClassClass IIStatusCompletedWhereArizona, Georgia, Idaho, Texas and Virginia
- Medical device recall MectaLIF ANTERIOR - Lag Plate Flush H16 There is a potential for breakage of the small screw used to affix the anti-backout plate. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 26, 2023ClassClass IIStatusCompletedWhereArizona, Georgia, Idaho, Texas and Virginia
- Medical device recall MectaLIF ANTERIOR - Lag Plate Flush H18 There is a potential for breakage of the small screw used to affix the anti-backout plate. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 26, 2023ClassClass IIStatusCompletedWhereArizona, Georgia, Idaho, Texas and Virginia
- Medical device recall MectaLIF ANTERIOR - Antibackout Lag Cover There is a potential for breakage of the small screw used to affix the anti-backout plate. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 26, 2023ClassClass IIStatusCompletedWhereArizona, Georgia, Idaho, Texas and Virginia
- Medical device recall Avanos Ballard Oral Care Swab, Bulk Incorrect expiration date. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile. The CirClamp subassembly found in the kit was the incorrect size. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide, and California and Texas named
- Medical device recall Medtronic SenSight Extension Tunneler Kit Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Kiestra InoqulA+ with BD Kiestra” InoqulA+” and BeA Software version 5.1 and 5.1.1 as part of the Icefall… Upon installation of BD Kiestra” InoqulA+” and BeA version 5.1 and 5.1.1 as part of the Icefall A platform, plate information was not visible in Synapsys”… Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois and New York named
- Medical device recall SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6 There are technical issues related to signal generation and processing, which can lead to inaccurate presentations. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 There are technical issues related to signal generation and processing, which can lead to inaccurate presentations. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Single Use Rotatable Clip Fixing Device There have been complaints that the clip did not come out of the tube sheath during the procedure. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beckman Coulter Access Free T3, Triiodothyronine, Free The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers… Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. Class IIFDA’s classApr 26, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 26, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ivenix Infusion System (IIS), Large Volume Pump Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 19, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 19, 2023ClassClass IStatusOngoingWhereCalifornia, Colorado, New Jersey, Utah and Wisconsin
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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