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 5, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital… Potential for units suspended on the ceiling to fail and fall. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic… Potential for units suspended on the ceiling to fail and fall. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic… Potential for units suspended on the ceiling to fail and fall. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic… Potential for units suspended on the ceiling to fail and fall. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system Potential for units suspended on the ceiling to fail and fall. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Indiana, Kansas, Louisiana, Maine, Minnesota, New Jersey, New York, Ohio, Rhode Island, South Carolina and Texas
- Medical device recall RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Indiana, Kansas, Louisiana, Maine, Minnesota, New Jersey, New York, Ohio, Rhode Island, South Carolina and Texas
- Medical device recall Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W… Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusCompletedWhereArizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Maryland, Montana, Nebraska, Nevada, Ohio, Tennessee, Texas, Utah and Virginia
- Medical device recall Philips Affiniti 70, Diagnostic Ultrasound System Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusCompletedWhereArizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Maryland, Montana, Nebraska, Nevada, Ohio, Tennessee, Texas, Utah and Virginia
- Medical device recall CONTRA GRAY (soft) TURBO PLUS CUPS one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereIndiana, Missouri and Tennessee
- Medical device recall Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F Non-sterile product labeled as sterile was distributed. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportOklahomathe one state its words name PublishedNov 15, 2023ClassClass IStatusOngoingWhereOklahoma
- Medical device recall Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml… Expired product distributed Class IIFDA’s classNov 15, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereMinnesota, New Hampshire, New Jersey, New York, Ohio and Texas
- Medical device recall EVIS EXERA III Gastrointestinal Videoscope Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR)… There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardiohelp-i, blood oxygenation and carbon dioxide removal system It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stolen McGRATH MAC Video Laryngoscopes Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 8, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 8, 2023ClassClass IStatusOngoingWhereNo state named
- Medical device recall McGrath Mac 2, Disposable Laryngoscope Blade Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall McGrath Mac 2, Disposable Laryngoscope Blade Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Surgical System. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 8, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 8, 2023ClassClass IStatusTerminatedWhereFlorida, Illinois, Louisiana, Minnesota and New Jersey
- Medical device recall AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM Peripheral coil system detachable has a potential of unsealed pouch packaging. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Michigan, Nevada, New York, Texas, Virginia and Washington named
- Medical device recall Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment.… Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ***Updated 12/4/23*** Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Q2 Multiport Extension set For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereAlabama, California, Colorado, Florida, Illinois, Michigan, Minnesota, Missouri, Montana, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall RX Imola-IVD Clinical Chemistry Analyzer RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall RX Modena-IVD Clinical Chemistry Analyser RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall RX Monaco-IVD Clinical Chemistry Analyser RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Coapt Dome Electrode, Gen2 system, cutaneous electrode Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Coapt ControlSeal Electrode, cutaneous EMG Electrode Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement Report18 statesnamed in where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereArizona, California, Florida, Hawaii, Illinois, Indiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Ohio, Pennsylvania, South Carolina, Texas, Virginia and Washington
- Medical device recall RayCare 5B and 6A including service packs- An oncology information system used to support workflows and… An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereMaryland and Tennessee
- Medical device recall Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of… Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or… Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abbott NT2000iX Radiofrequency (RF) generator Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereAlabama, Arkansas, California, Florida, Georgia, Indiana, Kentucky, Michigan, New Jersey, Oklahoma, Pennsylvania, Tennessee and Texas
- Medical device recall Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing… Reports were received the elastomer cup material is crumbling. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HILLROM PROGRESSA+ BED Progressa+ beds have the potential for static buildup from the casters and/or power drive. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Indiana, Massachusetts, New York, Ohio, Texas and Virginia named
- Medical device recall Unity CR Femur Right, Size 6 Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereIllinois, Michigan and Texas
- Medical device recall Unity Total Knee System Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereIllinois, Michigan and Texas
- Medical device recall Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in “invalid” results or no result test results. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Xpert Xpress Strep A pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in “invalid” results or no result test results. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LEAD 3387S-40 STIMLOC DBS There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 8, 2023ClassClass IIStatusCompletedWhereFlorida, Missouri, Texas and Washington
- Medical device recall One Step Pregnancy Test Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall One Step Ovulation Test Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall HealthyWiser UriTest” 10 Parameter Reagent Test Strips for Urinalysis Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall HealthyWiser UriTest” UTI Test Strips Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
- Medical device recall HealthyWiser KetoFast” Ketone Test Strips Universal Meditech Inc. Class IIFDA’s classNov 1, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedNov 1, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Louisiana, New Jersey, New York, Texas and Wyoming
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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