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 7, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- OR2020 BASIN SET Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- ENT SNUF3 SNUFFER KIT Y Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- PT225 PAIN MANAGEMENT TRAY Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK… Incomplete seals on the sterile package may compromise the sterility Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vaginal Verification Panel Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereCalifornia, Kansas, Maine, North Carolina, New York, Oregon and Utah
- Medical device recall SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004 Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Telescopic Smoke Evac Pencil, PB, Coated, Product No Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Telescopic Uncoated (Push Button), Product No Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. Class IIIFDA’s classFeb 12, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIIStatusTerminatedWhereDelaware and New York
- Medical device recall WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS) This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart… The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereMinnesota, New York, Ohio and Pennsylvania
- Medical device recall (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 23G PFC Injection Needle Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669 Microscopic tears of the sterile pouch may compromise sterility Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica… On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and… Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Custom Healthcare Systems, Inc A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall AQURE basic sytem, FLEXLINK The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when… Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Medline DYNDA1928 VP TRAY WITH PVP There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportKentuckythe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereKentucky
- Medical device recall RayStation stand-alone software treatment planning system Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf… Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Healon GV PRO 0.85 mL Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional… Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement Report46 statesnamed in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Cyberonics VNS Therapy AspireHC This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on… Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cyberonics VNS Therapy AspireSR This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on… Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting… On September 27, 2019 Energetiq Technology (the manufacturer) discovered a problem with their EQ-400-RH-QZ and EQ-400-LH-BK products during routine… Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 5, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a… Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance… It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance… It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 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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