Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, 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.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall The product is a handheld ultraviolet-C germicidal wand and contains narrow-diameter, tubular lamps with a… Excessive ultraviolet-C radiation Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centricity PACS-IW with Universal Viewer version 5.0 There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Delaware, Florida, Iowa, Illinois, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Oklahoma, Oregon, South Dakota, Texas, Wisconsin, West Virginia and Wyoming named
- Medical device recall Centricity Universal Viewer 6.0 There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Delaware, Florida, Iowa, Illinois, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Oklahoma, Oregon, South Dakota, Texas, Wisconsin, West Virginia and Wyoming named
- Medical device recall ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form… Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q The firm has received complaints of the device becoming hot. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Denticator PICK-A-DENT, periodontal aid - intradental pick mislabeled product Class IIIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 28, 2022ClassClass IIIStatusOngoingWhereNationwide, and Iowa, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Massachusetts, Michigan, Pennsylvania and Texas named
- Medical device recall Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia, Massachusetts, Michigan, Pennsylvania and Texas named
- Medical device recall VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 28, 2022ClassClass IIStatusTerminatedWhereNationwide, and Georgia named
- Medical device recall B105P Patient Monitor (with E-module slot option) GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2… Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall B125P Patient Monitor (with E-module slot option) GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2… Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall B105M Patient Monitor GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2… Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall B125M Patient Monitor GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2… Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall B125M Patient Monitor GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2… Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a… (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to… Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and… Due to Cranial Access Kits containing recalled sterile surgical drapes. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Maryland, Michigan, Montana, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Texas and Washington named
- Medical device recall Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in… Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Class IIIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIIStatusOngoingWhereNo state named
- Medical device recall Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in… Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Class IIIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIIStatusOngoingWhereNo state named
- Medical device recall X-CORE 2 Ti Core, Static Potential that insert will be unable to disengage from the vertebral body replacement device/implant Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Abbott Alinity m Resp-4-Plex Amp Kit Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Abbott Alinity m Resp-4-Plex Amp Kit Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall InPen Diabetes Management App, part of the InPen System Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to… Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall HeartWare Model 1100 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare Model 1101 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare Model 1102 Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare HVAD Pump Kit Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare HVAD Pump Kit Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare HVAD Pump Kit Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare HVAD Pump Kit Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare HVAD Pump Kit Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HeartWare HVAD Pump Kit Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medical Action INDUSTRIES INC XXX Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 28, 2022ClassClass IIStatusTerminatedWhereNationwide, and Virginia named
- Medical device recall Vivid S5 Ultrasound Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedDec 28, 2022ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Vivid S6 ultrasound Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedDec 28, 2022ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Vivid S5 N ultrasound Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedDec 28, 2022ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Vivid S6 N ultrasound Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedDec 28, 2022ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Vivid i ultrasound Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedDec 28, 2022ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Vivid q ultrasound Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedDec 28, 2022ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Vivid i N ultrasound Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedDec 28, 2022ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Vivid q N ultrasound Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedDec 28, 2022ClassClass 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Revaclear 400 Dialyzer Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide, and Guam and US Virgin Islands named
- Medical device recall Revaclear 400 Dialyzer Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide, and Guam and US Virgin Islands named
- Medical device recall Revaclear 300 dialyzers Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revaclear 400 dialyzers Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Revaclear 400 dialyzers Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medical Action Industries Inc Scissors contained debris. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 28, 2022ClassClass IIStatusTerminatedWhereFlorida, Illinois, Indiana, Massachusetts, Maryland, Missouri, Ohio and Virginia
- Medical device recall Lamaze Chill Teether, Fluid-Filled Teething Ring Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. Class IIFDA’s classDec 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 21, 2022in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 21, 2022ClassClass IStatusTerminatedWhereFlorida, Georgia, Kentucky, Ohio, Pennsylvania and West Virginia
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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