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 Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m single use devices labeled as sterile may not have been adequately sterilized Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland and Texas named
- Medical device recall Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic… Malware attack Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system There is a potential for abnormal inflation of the mattress. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits… Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood… Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an… Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. Class IIFDA’s classJun 9, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended… Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree Class IIFDA’s classJun 9, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Kentucky and Maryland
- Medical device recall Zimmer Natural Nail- ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 130 CCD Left Ti-6Al-4V Alloy-is… Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree Class IIFDA’s classJun 9, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Kentucky and Maryland
- Medical device recall BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting Certain devices were built with motor assemblies that could contain non-conforming plastic material. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Louisiana, Missouri, Oklahoma, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall BiPAP A40, China: Continuous ventilator, non-life-supporting Certain devices were built with motor assemblies that could contain non-conforming plastic material. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Louisiana, Missouri, Oklahoma, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting Certain devices were built with motor assemblies that could contain non-conforming plastic material. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Louisiana, Missouri, Oklahoma, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting Certain devices were built with motor assemblies that could contain non-conforming plastic material. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Louisiana, Missouri, Oklahoma, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall BiPAP A30, Brazil: Continuous ventilator, non-life-supporting Certain devices were built with motor assemblies that could contain non-conforming plastic material. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Louisiana, Missouri, Oklahoma, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall BiPAP A40, Brazil: Continuous ventilator, non-life-supporting Certain devices were built with motor assemblies that could contain non-conforming plastic material. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Louisiana, Missouri, Oklahoma, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Access SARS-CoV-2 Antigen specimens collected in transport media may result is false negative results when stored in certain conditions. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and West Virginia named
- Medical device recall IntelliVue MX40 Patient Monitor Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and Indiana and Minnesota named
- Medical device recall GS777 Wall Transformer Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative… Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 2, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501,… Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJun 2, 2021ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, West Virginia and Wyoming named
- Medical device recall Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention… Removing parts for safety reasons due to possible breakage. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Minnesota and Washington named
- Medical device recall NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or… Not manufactured to specification Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Oklahoma and Washington named
- Medical device recall NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or… Not manufactured to specification Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Oklahoma and Washington named
- Medical device recall NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or… Not manufactured to specification Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Oklahoma and Washington named
- Medical device recall NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or… Not manufactured to specification Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Oklahoma and Washington named
- Medical device recall NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or… Not manufactured to specification Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Oklahoma and Washington named
- Medical device recall Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other… IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated… Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, District of Columbia, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, Pennsylvania and Texas named
- Medical device recall PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood… Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Jersey, New York, Oklahoma, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Gambro Cartridge Blood Set There is a potential leak between the venous patient connector and patient’s hemodialysis access. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 2, 2021ClassClass IIStatusOngoingWhereDelaware, Ohio and Utah
- Medical device recall MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking… Due to a failure of the welds, the casters detached from the rear legs of the walker. Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 2, 2021ClassClass IIStatusOngoingWhereNationwide, and California and Wisconsin named
- Medical device recall VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended… Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS… Class IIFDA’s classJun 2, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 2, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Iowa, Illinois, Louisiana, Missouri, Mississippi, Texas and Wisconsin named
- Medical device recall VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the… The firm has received reports of stent migration after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)May 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall VICI RDS VENOUS STENT System Product Usage: is indicated for improving luminal diameter in the iliofemoral… The firm has received reports of stent migration after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)May 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Kansas, Maryland, Minnesota, Nebraska, New York, Oklahoma, Rhode Island, Texas and Virginia named
- Medical device recall Alpha Interlock Suspension System Lanyard Body: An external prosthetic device the firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8 pin. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Minnesota, Missouri, Mississippi, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia and Washington named
- Medical device recall Elecsys Troponin I STAT Immunoassay Recall reason is possible sporadic false negative conventional troponin results. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall Elecsys Troponin I Immunoassay Recall reason is possible sporadic false negative conventional troponin results. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming named
- Medical device recall RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including… For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RayStation standalone software radiation therapy treatment planning system When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMay 26, 2021ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN:… Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose… Class IIFDA’s classMay 26, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 26, 2021ClassClass IIStatusOngoingWhereNo 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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