Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical… Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Michigan, Mississippi, North Dakota, New Jersey, Oregon, Texas, Virginia and West Virginia named
- Medical device recall Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical… Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Michigan, Mississippi, North Dakota, New Jersey, Oregon, Texas, Virginia and West Virginia named
- Medical device recall Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical… Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Michigan, Mississippi, North Dakota, New Jersey, Oregon, Texas, Virginia and West Virginia named
- Medical device recall Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical… Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Michigan, Mississippi, North Dakota, New Jersey, Oregon, Texas, Virginia and West Virginia named
- Medical device recall Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical… Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Michigan, Mississippi, North Dakota, New Jersey, Oregon, Texas, Virginia and West Virginia named
- Medical device recall Access Testosterone assay Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportFloridathe one state its words name PublishedJun 11, 2025ClassClass IIStatusOngoingWhereFlorida
- Medical device recall VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges. Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 11, 2025ClassClass IIStatusCompletedWhereNationwide, and Alabama, Arizona, California, Connecticut, Georgia, Maryland, Minnesota, New Jersey, South Carolina, Texas, Virginia, Vermont and Washington named
- Medical device recall MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 11, 2025ClassClass IIStatusCompletedWhereCalifornia, Florida and Nebraska
- Medical device recall Dexcom G7 iOS Application A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette A manufacturing defect in the sample probe (S probe). Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJun 11, 2025ClassClass IIStatusCompletedWhereNationwide, 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 Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJun 11, 2025ClassClass IIStatusCompletedWhereNationwide, 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 Pre-filled Water Syringe During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ChannelCheck Convenience Pack During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus EVIS EXERA III Duodenovideoscope Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxI 9000 Access Immunoassay Analyzer A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being… Class IIFDA’s classJun 11, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 11, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Apo B Reagent The product Value Assignment Sheet (VAS) is used in calibration of the device. Class IIIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJun 4, 2025ClassClass IIIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and West Virginia named
- Medical device recall Affinity 4 Birthing Bed There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Kentucky and Wisconsin named
- Medical device recall ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Kentucky and Wisconsin named
- Medical device recall Atellica IM Homocysteine Calibrator Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Vermont, Wisconsin and Wyoming named
- Medical device recall ADVIA Centaur HCY Calibrator Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Virginia, Vermont, Wisconsin and Wyoming named
- Medical device recall Cardiohelp System HKH 8820 Wall Holder HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereIllinois and Missouri
- Medical device recall ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall HEMOCUE INC F/GLUCOSE 201 ANALYZER transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall BD MICROBIOLOGY MAC CONKEY II AGAR transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT POINT OF CARE TEST CREA I-STAT transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia 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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