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 Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereIowa, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin
- Medical device recall CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative… Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia and Washington named
- Medical device recall FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies… Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia and Washington named
- Medical device recall Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and… Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia and Washington named
- Medical device recall Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2,… Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia and Washington named
- Medical device recall Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 1, 2021ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 1, 2021ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 1, 2021ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AQUABEAM Handpiece Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 1, 2021ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Michigan, New Jersey, New York, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall AltiVate Anatomic Shoulder System for the following Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement Report35 statesnamed in where it went PublishedSep 1, 2021ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall Normand Remisol Advance Data Manager There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Massachusetts, North Carolina, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall BD” Mouse IgG2a Isotype Control APC X39 ASR Complaints have been received for performance issues related to high background and staining. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Kentucky, New York and Pennsylvania named
- Medical device recall NES Reprocessed Visions PV .035 IVUS Catheter, Sterile 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Illinois, Massachusetts, North Carolina, New Jersey, New York and Texas named
- Medical device recall AUGMENT Injectable Kit, 3cc The kit contains the wrong vial tray in the package. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall KeyPrint Soft- bottle, 32.5 oz Product label intended for the European community was distributed to the USA market via their US distribution organization Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 1, 2021ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall ECHELON MRI System There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of… Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ECHELON Oval MRI System There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of… Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OASIS MRI System There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of… Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gore Molding & Occlusion Balloon Catheter Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or… Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedSep 1, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas and Virginia named
- Medical device recall Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas and Virginia named
- Medical device recall Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas and Virginia named
- Medical device recall Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas and Virginia named
- Medical device recall Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas and Virginia named
- Medical device recall Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas and Virginia named
- Medical device recall Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Maryland, New Hampshire, New York, Ohio, Tennessee, Texas and Virginia named
- Medical device recall ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2) Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1 Electronic Patient Gas System intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System Test strip vials may open while inside sealed cartons during shipment. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Accu-Chek Performa Test Strip, Blood Glucose Monitoring System Test strip vials may open while inside sealed cartons during shipment. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System Test strip vials may open while inside sealed cartons during shipment. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System Test strip vials may open while inside sealed cartons during shipment. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HARMONIC HD 1000i Shears An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in… Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HARMONICHD 1000i Shears An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in… Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B,… Two software issues have been identified related to pressure increase in the device: The first issue is described as “Infant/Pediatric EFS Calibration Pressure… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B,… Two software issues have been identified related to pressure increase in the device: The first issue is described as “Infant/Pediatric EFS Calibration Pressure… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B Two software issues have been identified related to pressure increase in the device: The first issue is described as “Infant/Pediatric EFS Calibration Pressure… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Trilogy Evo Universal, Product number DS2000X11B Two software issues have been identified related to pressure increase in the device: The first issue is described as “Infant/Pediatric EFS Calibration Pressure… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Aequalis Pyrocarbon Humeral Heads Potential patient exposure to the graphite substrate. Class IIFDA’s classAug 25, 2021in FDA’s Enforcement Report15 statesnamed in where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereCalifornia, Colorado, Connecticut, Florida, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Oregon, Pennsylvania, Texas and Wisconsin
- Medical device recall Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereArizona, California, District of Columbia, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Nebraska and Washington
- Medical device recall Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are… Class IIFDA’s classAug 25, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereArizona, California, District of Columbia, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Nebraska and Washington
- Medical device recall Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS) Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DELTAVEN Safety I.V Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida and Minnesota named
- Medical device recall DELTAVEN Y DNL Safety I.V Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida and Minnesota named
- Medical device recall DELTAVEN FASTFLASH, Safety I.V Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida and Minnesota named
- Medical device recall DELTAVEN Y, Safety I.V Problems related to the sterilization of the medical devices; possible missing sterility of the medical device Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide, and Florida and Minnesota 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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