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 5, 2026.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall DxA 5000 (DxA Automation System, DxA 5000 fit), “For in Vitro Diagnostic Use”, Reference Numbers: B87352 with… There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Illinois, Kentucky, Michigan, Minnesota, Ohio, Pennsylvania, Texas and West Virginia named
- Medical device recall Corin TriFit TS, Size 8, Standard Tapered Stem The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4 The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah and Wisconsin named
- Medical device recall DuoDERM Control Gel Formula Border Dressings 15x15cm Primary packaging labeling may be incorrect. Class IIFDA’s classOct 6, 2021in FDA’s Enforcement Report13 statesnamed in where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereCalifornia, Florida, Georgia, Illinois, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically… Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 6, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Xcela PICC with PASV Valve Technology/Kit 5 F-55cm Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec). Class IIFDA’s classOct 6, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 6, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic… Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and… Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 29, 2021ClassClass IStatusOngoingWhereNationwide, and California, Colorado, Florida, Kentucky, Maryland, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Virginia and Washington named
- Medical device recall EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C -… Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 29, 2021ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121… Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 29, 2021ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control… The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences). Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control… The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Maryland, Minnesota, Montana, North Carolina, Nevada, New York, Oregon, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16” Sq A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the… Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Idaho, Kansas, Kentucky, Louisiana, Michigan, Missouri, North Carolina, New York, Texas, Virginia, Washington and West Virginia named
- Medical device recall Bone Marrow Transplantation biopsy needle Sterility assurance may be compromised. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aspirated Cyto-Histological Biopsy needle Sterility assurance may be compromised. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mammary Nodules Localization Sterility assurance may be compromised. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Soft Tissue Biopsy Needles Sterility assurance may be compromised. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall General Manual surgical instrument Sterility assurance may be compromised. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to… Incorrect version of labels were used. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Florida, Michigan, New York, Pennsylvania and Texas named
- Medical device recall Ad-Tech Lightweight TECH ATTACH Cable - Product Usage: Designed for the purpose of connecting these… Incorrect version of labels were used. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Florida, Michigan, New York, Pennsylvania and Texas named
- Medical device recall Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third… Incorrect version of labels were used. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Florida, Michigan, New York, Pennsylvania and Texas named
- Medical device recall EVIS EXERA BF-XT160 Bronchofibervideoscope A gluing step was not performed during the manufacturing of the affected device’s insertion tube. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, Maryland, Michigan, New York, Ohio, Oregon and Pennsylvania named
- Medical device recall cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System Customers have reported an increased number of false positive SARS-CoV-2 results. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Illinois, Indiana, Kansas, Maine, Michigan, Minnesota, Missouri, New York, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a,… Software versions may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp… As a result of design changes, sheaths have exhibited cracking/breaking at the tips. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide, and Washington named
- Medical device recall Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including… Image acquisition failures and synchronization failure with the Centricity Enterprise Archive Class IIFDA’s classSep 29, 2021in FDA’s Enforcement Report34 statesnamed in where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images… Image acquisition failures and synchronization failure with the Centricity Enterprise Archive Class IIFDA’s classSep 29, 2021in FDA’s Enforcement Report34 statesnamed in where it went PublishedSep 29, 2021ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall DLP Left Heart Vent Catheters, 16 FR Potential for a wire protrusion through the left heart vent catheter tip Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall DLP Left Heart Vent Catheters, 18 FR Potential for a wire protrusion through the left heart vent catheter tip Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedSep 29, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall CoLink Bone Graft Harvester, 8mm, Sterile, Disposable Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Louisiana, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich… Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Missouri, Montana, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia and Washington named
- Medical device recall Access SARS CoV-2 IgG Firm’s submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, Iowa, Illinois, Kentucky, Michigan, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and Washington named
- Medical device recall Univation X System knee implant devices as follows Malfunction- loosening of the implant resulting in a potential revision surgery Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Univation X System knee implant devices as follows Malfunction- loosening of the implant resulting in a potential revision surgery Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Univation X System knee implant devices as follows Malfunction- loosening of the implant resulting in a potential revision surgery Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Univation X System knee implant devices as follows Malfunction- loosening of the implant resulting in a potential revision surgery Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Univation X System knee implant devices as follows Malfunction- loosening of the implant resulting in a potential revision surgery Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Univation X System knee implant devices as follows Malfunction- loosening of the implant resulting in a potential revision surgery Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Univation X System knee implant devices as follows Malfunction- loosening of the implant resulting in a potential revision surgery Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
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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