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 6, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Bentson Wire Guide, Guidewire (OUS ONLY) Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Bentson Wire Guide Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Coons Interventional Wire Guide, Guidewire Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Double Flexible Tipped Wire Guide, Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Fixed Core Wire Guide, Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Fixed Core Wire Guide (Straight), Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner PC Wire Guide (Nimble), Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Roadrunner PC Wire Guide (The Firm), Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Rosen Curved Wire Guide, Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Torq-Flex Wire Guide Australian Modification, Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Vinyl Connecting Tube, Connecting Tube Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Lunderquist -Ring Torque Wire Guide, Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica Surgical Operating Microscopes, ARveo 8 During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an… Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica Surgical Operating Microscopes, Arveo During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an… Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica Surgical Operating Microscopes, M530 OHX During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an… Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Leica Surgical Operating Microscopes, PROvido During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an… Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503 Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedOct 5, 2022ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001 Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedOct 5, 2022ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall Barco Medical Network Adapter, MNA-240, part of the NexxisOR system installation issues Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois and New Jersey named
- Medical device recall MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20… Potential for the suction catheter to come apart from the green connector near the thumb valve. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, 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 MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton… Potential for the suction catheter to come apart from the green connector near the thumb valve. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, 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 MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20… Potential for the suction catheter to come apart from the green connector near the thumb valve. Class IIFDA’s classOct 5, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedOct 5, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, 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 BD MaxGuard Extension Set with 4-way stopcock Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement Report39 statesnamed in where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall BD MaxGuard Extension Set Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement Report39 statesnamed in where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall BD MaxGuard Flow Controller Extension Set with Needleless Y-Site Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement Report39 statesnamed in where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall BD MaxGuard Flow Controller Extension Set with Needleless Y-Site Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement Report39 statesnamed in where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way… Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement Report39 statesnamed in where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall BD MaxGuard Extension Set with 2 Needleless Y-Site Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement Report39 statesnamed in where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement Report39 statesnamed in where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement Report39 statesnamed in where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement Report39 statesnamed in where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall BEQ-HLS 7050 USA The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product… Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BEQ-HLS 5050 USA The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product… Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BEQ-HLS 5050 USA The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product… Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BEQ-HLS 7050 USA The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product… Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama named
- Medical device recall AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis… Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured Class IIFDA’s classSep 28, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 28, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Nevada, New York, Pennsylvania and Texas 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.
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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