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 Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific” Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific” Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific” Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific” Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific” Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific” Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific” Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific” Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST An internal technical investigation has confirmed that Thermo Scientific” Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall CAIRE Liberator 45 An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, North Carolina and Ohio named
- Medical device recall CAIRE Liberator 45 An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, North Carolina and Ohio named
- Medical device recall CAIRE Liberator 30 An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, North Carolina and Ohio named
- Medical device recall CAIRE Liberator 20 An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 14, 2022ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, North Carolina and Ohio named
- Medical device recall IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE… Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Indiana, Kentucky, North Carolina, Nebraska, Oregon, South Dakota, Texas and Utah named
- Medical device recall Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dover Closed Urethral Tray with Vinyl Catheter Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 14, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, North Carolina, New Jersey and West Virginia named
- Medical device recall IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 14, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, North Carolina, New Jersey and West Virginia named
- Medical device recall FULL VISION INC This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereGeorgia and New York
- Medical device recall FULL VISION INC This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereGeorgia and New York
- Medical device recall FULL VISION INC This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereGeorgia and New York
- Medical device recall FULL VISION INC This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereGeorgia and New York
- Medical device recall FULL VISION INC This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereGeorgia and New York
- Medical device recall FULL VISION INC This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereGeorgia and New York
- Medical device recall FULL VISION INC This has been identified a rare occurrence, under a specific scenario, where the circuit is found in a latch-up condition on the PCB that controls the safety… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereGeorgia and New York
- Medical device recall 2.5 mm LifePort Endotracheal Tube Adapters 10-pack Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical… A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR… Class IIFDA’s classDec 14, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 14, 2022ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Colorado, Florida, Illinois, New Hampshire and South Carolina
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CareFusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carefusion V BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content that is contained in the manufacturer’s IFU. Class IIFDA’s classDec 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2022ClassClass IIStatusOngoingWhereNationwide
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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