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 LUMINOS Lotus Max (VF11) Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Olympus Single Use Distal Cover The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure… Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMay 31, 2023ClassClass IIStatusOngoingWherePennsylvania
- Medical device recall ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided… Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance… Class IIIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 31, 2023ClassClass IIIStatusOngoingWhereNo state named
- Medical device recall To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and… Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance… Class IIIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 31, 2023ClassClass IIIStatusOngoingWhereNo state named
- Medical device recall Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereAlabama and New York
- Medical device recall EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 31, 2023in FDA’s Enforcement Report16 statesnamed in where it went PublishedMay 31, 2023ClassClass IStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Massachusetts, Minnesota, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah and Wisconsin
- Medical device recall Aligned Medical Solutions Spine Pack Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedMay 31, 2023ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall Aligned Medical Solutions Minor Hand Pack Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedMay 31, 2023ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall Aligned Medical Solutions Hand Pack Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedMay 31, 2023ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall Incisive CT- whole-body computed tomography (CT) X-Ray System Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereArkansas, California, Oklahoma and Texas
- Medical device recall Incisive CT- Whole-body computed tomography (CT) X-Ray System Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereArkansas, California, Oklahoma and Texas
- Medical device recall Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereArkansas, California, Oklahoma and Texas
- Medical device recall Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereArkansas, California, Oklahoma and Texas
- Medical device recall binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and… May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMay 31, 2023ClassClass IIStatusOngoingWherePennsylvania
- Medical device recall VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated… Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arjo Portable Scale Adaptor Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNew York and Ohio
- Medical device recall ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2),… Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro… Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Seattle PAP Plus, MP02260 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VentStar Basic (P)180, MP00351 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VentStar Basic (P)250, MP00352 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VentStar Watertrap (P) 180, MP00361 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VentStar Watertrap (P) 180 w/oLL, MP00362 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VentStar Anesthesia WT (P)180, MP00374 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VentStar breathing bag Set (P) 110, MP00384 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ID Circuit Basic (P) 180, MP01340 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VentStar Anesthesia (N) 180, MP00333 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VentStar Basic (N) 180, MP00353 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VentStar Watertrap (N) 180, MP00363 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VentStar Bag Set (N) 110, MP00383 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VentStar Coax (P) 150, MP00379 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Anesthesia Circuit Kit Coax 1, MP02730 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Anesthesia Circuit Kit Coax 3, MP02732 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Ventstar Coax, MP03373 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Ventstar Coax 180, MP03374 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ID Coax 180, MP03375 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Ventstar Coax 230, MP03376 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Anesthesia Set Coax 180, MP03384 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Set2Go Ventilation 12 (A), MP07968 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Anesthesia Circuit Kit Coax HEPA, MP17102 Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a)… Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ASM Replacement Battery, Component Number SUB0000864 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall ASM Replacement Battery, Component Number SUB0000594 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 24, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 24, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall DuraLife Autoclavable Double Swivel Elbow DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DuraLife Autoclavable Silicone Extension Tube DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 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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