Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, 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.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Custom Cancellous Thread Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall M/H MODULAR STEM Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OSS Polyethylene Tibial Bushing Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oxford Fixed Lateral Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PHOENIX, Interlocking screw for IM nail Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RapidFire Clip Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RINGLOC ACETABULAR SYSTEM Self-tapping bone screws Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RINGLOC BIPOLAR Hip System Bi Polar Locking Ring Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sterile Trac System Thinflap 24 MM Burr Hole Plate Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Titanium IFS Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RingLoc+ Quick Connect Drill Bit Specific lots of multiple sterile medical devices may have a breach in the sterile seal. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HLS Set Advanced The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product’s sterility barrier. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HLS Set Advanced The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product’s sterility barrier. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tina-quant C-Reactive Protein Gen.3 Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and… Due to complaints received associated with cracked/split test tube caps. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 23, 2020ClassClass IIStatusOngoingWhereNationwide, and New Jersey, New York, Pennsylvania and Texas named
- Medical device recall Kowa VK-2s software Version 10.0.4.0 It has been determined that the software distributed with the retinal camera may delete patient information. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 23, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Idaho, Illinois, Massachusetts, Michigan, New York, Texas and Washington named
- Medical device recall EKOS Control System (CU) 4.0 This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. Class IIFDA’s classDec 23, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 23, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option There is a potential that the adjustable handle option on the X-Ray system may have been installed with improper bolts. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 16, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent… During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid… Products do not meet stability criteria and may impact results. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and California and New York named
- Medical device recall MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for… Products do not meet stability criteria and may impact results. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and California and New York named
- Medical device recall MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended… XXX Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and California and New York named
- Medical device recall MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended… XXX Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and California and New York named
- Medical device recall CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector Detachment of the Male AIV Adaptor from the Y-Connector. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Illinois, Louisiana, Ohio and Virginia
- Medical device recall Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 Possible false negative or false positive results. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereColorado, Illinois, Indiana, Missouri, Ohio, Rhode Island, Utah and Virginia
- Medical device recall Everest MI XT Tab Removal Tool (i.e All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in… Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAC VU360, Electrocardiograph Incorrect patient identification and/or patient demographic errors. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement Report50 statesnamed in where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereAlabama, 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, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Philips IntelliVue X2 Multi measurement Server: M3002A Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and South Dakota named
- Medical device recall Philips IntelliVue MP2 Patient Monitors Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and South Dakota named
- Medical device recall Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and… Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and Georgia and New Jersey named
- Medical device recall Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum,… Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and Georgia and New Jersey named
- Medical device recall Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation… Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and… A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan… Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PROKERA, non-sterile - Product Usage: Biologic corneal bandage. Potential exposure of product to microbial contamination. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Washington named
- Medical device recall PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage. Potential exposure of product to microbial contamination. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Washington named
- Medical device recall PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage. Potential exposure of product to microbial contamination. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Washington named
- Medical device recall ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting… The radio within the device can become disassociated with the wireless access point. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product… The firm has identified a problem with the control software for the celling arm of the X-Ray System . Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedDec 16, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Illinois, Indiana, Kentucky, Louisiana, Michigan, Montana, North Carolina, New York, Ohio, South Carolina and Tennessee named
- Medical device recall Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage:… The firm has identified a problem with the control software for the celling arm of the X-Ray System . Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedDec 16, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Illinois, Indiana, Kentucky, Louisiana, Michigan, Montana, North Carolina, New York, Ohio, South Carolina and Tennessee named
- Medical device recall MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac… The firm has identified a problem with the control software for the celling arm of the X-Ray System . Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedDec 16, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Illinois, Indiana, Kentucky, Louisiana, Michigan, Montana, North Carolina, New York, Ohio, South Carolina and Tennessee named
- Medical device recall MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials… Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular… Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall Evolut (TM) R System Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID). Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Evolut (TM) PRO System Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID). Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Evolut (TM) PRO+ System Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID). Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD” Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for… Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas and Virginia named
- Medical device recall Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming… During system upgrade incorrect comments may be added to existing tests. Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide, 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, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Olympus Ultrasound Endoscope A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of… Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass 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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