Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall Solero Generator Refurbished PG Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Solero Generator PG Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur… Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano. Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters There is potential for nonsterility of product due to a possible defect in the pouch seal. Class IIFDA’s classSep 15, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, New Jersey, New York and Tennessee
- Medical device recall MIVI Super 90 8F Guide Catheter, 95 cm There is potential for nonsterility of product due to a possible defect in the pouch seal. Class IIFDA’s classSep 15, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, New Jersey, New York and Tennessee
- Medical device recall CombiDiagnost R90 Software Version R1.0 and R1.1 Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Baxter PrismaFlex Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baxter prismaflex, HF 1000 PAES membrane Products labeled as sterile were distributed, but may not have been sterilized. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and… Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Minnesota and Tennessee named
- Medical device recall EL-Anti-SARS-CoV-2 IgM Kit Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, North Carolina and Texas named
- Medical device recall EL-Anti-SARS-CoV-2 IgG Kit The cross-reactivity of the device may present an increased level of potential false positives. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, North Carolina and Texas named
- Medical device recall CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW… An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement Report44 statesnamed in where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001 There is an incorrect version of the needle in the introducer part of devices. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, New York and Ohio named
- Medical device recall DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Florida, Iowa, Ohio, Pennsylvania, South Carolina, Washington and Wisconsin named
- Medical device recall STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Florida, Iowa, Ohio, Pennsylvania, South Carolina, Washington and Wisconsin named
- Medical device recall Merge Hemo, Software packages 10.2, 10.3, and 10.4 The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Jessie Sterile Arm Suspension Kit Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product’s sterilization process was… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Marco Shoulder Stabilization Kit Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product’s sterilization process was… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Norton Arm Kit Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product’s sterilization process was… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for… Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU). Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Nebraska, New York, Pennsylvania, South Carolina, Texas, Virginia, West Virginia and Wyoming named
- Medical device recall TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as… Software: A coding error associated with the Fast3D Segmentation software. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas and Washington
- Medical device recall TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as… Software: A coding error associated with the Fast3D Segmentation software. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas and Washington
- Medical device recall TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as… Software: A coding error associated with the Fast3D Segmentation software. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas and Washington
- Medical device recall TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as… Software: A coding error associated with the Fast3D Segmentation software. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas and Washington
- Medical device recall TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as… Software: A coding error associated with the Fast3D Segmentation software. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas and Washington
- Medical device recall TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as… Software: A coding error associated with the Fast3D Segmentation software. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas and Washington
- Medical device recall TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as… Software: A coding error associated with the Fast3D Segmentation software. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Indiana, Michigan, Minnesota, New York, Texas and Washington
- Medical device recall smiths medical portex Tracheal Intubation Stylet The incorrect device is contained in the package. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee… Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002 The sterile barrier seal may be compromised. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNo state 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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