Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall FRT250 - 4.0-6.4 CARTRIDGE During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Class IIFDA’s classSep 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Texas named
- Medical device recall Baxter Spectrum Wireless Battery Modules A/B/G/N The Spectrum WBM may fail to auto-document infusion status information back to the hospital’s Electronic Medical Record (EMR) system. Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Spectrum Wireless Battery Modules A/B/G/N The Spectrum WBM may fail to auto-document infusion status information back to the hospital’s Electronic Medical Record (EMR) system. Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ClotTriever XL Catheter, 30 mm Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedAug 28, 2024ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, 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 and West Virginia named
- Medical device recall McGrath Mac Video Laryngoscope Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedAug 28, 2024ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall McGRATH” MAC EMS Video Laryngoscope Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedAug 28, 2024ClassClass 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall C-Flow Bag Decanter During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Bag Decanter II During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Bottle Decanter During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vial Decanter During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Transfer Device During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film. Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results. Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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 and West Virginia named
- Medical device recall Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: 25GA VALVED ENTRY SYSTEM,3CT Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Alcon Custom Pak Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: 20 Gauge V-Lance Knife Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: TOTAL PLUS,25+,10K VALVE STD Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: TOTAL PLUS,25+,10K VALVE WD Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: 25+TTLPL VPK 20000CPM BEV VAL Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic… Class IIFDA’s classAug 28, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2024ClassClass 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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