Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System… WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AGILE ESO OTW PC 23MM X 6.2CM WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AGILE ESO OTW PC 23MM X 10.1CM WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AGILE ESO OTW PC 23MM X 12.0CM WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AGILE ESO OTW PC 23MM X 15.0CM WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AGILE ESO OTW FC 23MM X 10.1CM WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AGILE ESO OTW FC 23MM X 15.0CM WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AGILE ESO FC RMV 23MM X 6.2CM WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AGILE ESO FC RMV 23MM X 10.1CM WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AGILE ESO FC RMV 23MM X 15.0CM WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Low concentration of sodium pyruvate in the wash could compromise gamete development Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa Low concentration of sodium pyruvate in the wash could compromise gamete development Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa Low concentration of sodium pyruvate in the wash could compromise gamete development Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arrow Arterial Kits and Trays as follows Reports have been received regarding open seals on the packaging. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Massachusetts, Maine, Michigan, North Carolina, New York, Pennsylvania and West Virginia named
- Medical device recall Custodiol HTK Solution, 500ml bottle. 10 per carton. Potential for particles to be present in solution. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and North Carolina named
- Medical device recall (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. Class IIFDA’s classOct 2, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 2, 2024ClassClass IIStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Medline Contro-Bulb Syringe Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet),… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Baxter EXACTAMIX Inlet, Vented, High Volume Inlet Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet),… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet),… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Baxter EXACTAMIX Inlet, Vented, Syringe Inlet Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet),… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Alaris System PC Unit Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Alaris PCA Module Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Alaris EtCO2 Module Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Alaris Syringe Module Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Alaris Pump Module Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended… During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Minnesota, New York and Pennsylvania named
- Medical device recall AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ViewPoint; system, imaging processing, radiological The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect,… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g)… The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect,… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Flexima Regular Kit Biliary Catheter System Kit, Material Numbers There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall VTC Regular Kit Nephrostomy Catheter System Kit, Material Number There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090… Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety The syringes that were inadvertently shipped from the Distribution Center. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Nevada and New York named
- Medical device recall stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, Illinois, Nevada, South Dakota and Wisconsin named
- Medical device recall Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the… Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ERIC Retrieval Device Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas and Virginia named
- Medical device recall regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled. Class IIFDA’s classSep 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2024ClassClass IIStatusOngoingWhereNationwide, and North Carolina named
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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