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 7, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324 Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cryo Module Accessories Domestic CMA-OUS, Product AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Packaged, Tank Hose Assembly CMA-US, Product AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Volar Bearing Plate Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereAlabama, California, Florida, Michigan and New York
- Medical device recall EZDilate Fixed Wire Balloon 6-7-8 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EZDilate Fixed Wire Balloon 8.5-9.5-10.5 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EZDilate Fixed Wire Balloon 11-12-13 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EZDilate Fixed Wire Balloon 13.5-14.5-15.5 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EZDilate Fixed Wire Balloon 16-17-18 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EZDilate Fixed Wire Balloon 18-19-20 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EZDilate Wire Guided Balloon 6-7-8 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EZDilate Wire Guided Balloon 8.5-9.5-10.5 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EZDilate Wire Guided Balloon 11-12-13 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EZDilate Wire Guided Balloon 13.5-14.5-15.5 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EZDilate Wire Guided Balloon 16-17-18 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EZDilate Wire Guided Balloon 18-19-20 Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and… Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 1.5T The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 1.5T Conversion The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 1.5T Initial system The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva 3.0T The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Achieva XR. Model (REF) Numbers 781153, 781253. The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 1.5T CX The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ingenia 3.0T CX The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Achieva Nova The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera 1.5T Achieva Nova-Dual The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intera Achieva 1.5T Pulsar The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. Class IIFDA’s classFeb 7, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 7, 2024ClassClass 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.”
Your shortlist0 of 4
Add one more to compare.