Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Due to a software issue Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Delaware, Florida, Georgia, Kansas, Massachusetts, Maryland, Maine, Michigan, North Carolina, New York, Ohio, South Carolina, Tennessee, Texas, Virginia and Vermont named
- Medical device recall NOxBOXi Nitric Oxide Delivery System. Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending… Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All… Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review,… Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data,… Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC)… Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SunMed Tracheal Tube, Size 2.5 The 6Fr suction catheter could not pass through the samples smoothly. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Michigan named
- Medical device recall GM Helix Implant There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia and Wisconsin named
- Medical device recall Brand Name: VERIQA When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Georgia and New York named
- Medical device recall Happiest Baby, Inc SNOO Sleep Sack, X-Small Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 23, 2026ClassClass 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, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Happiest Baby, Inc Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 23, 2026ClassClass 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, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Due to issue with endoscope adherence and inability to spray powder. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 23, 2026ClassClass 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, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide) Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Colorado and Florida named
- Medical device recall EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity… Retrospectively reported: Pen needles labeled ‘For Investigational Use Only’ were inadvertently distributed as commercially marketed devices. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas and Virginia named
- Medical device recall EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100 Retrospectively reported: Pen needles labeled ‘For Investigational Use Only’ were inadvertently distributed as commercially marketed devices. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas and Virginia named
- Medical device recall Blood Culture Collection Venipuncture Kit 20/Cs Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Indiana, North Carolina and Ohio named
- Medical device recall REF:2B5LT Ethicon Endo-Surgery, Inc Reusable access port system may crack or seperate during use. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall REF:2B5ST Ethicon Endo-Surgery, Inc Reusable access port system may crack or seperate during use. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall REF:B11LT Ethicon Endo-Surgery, Inc Reusable access port system may crack or seperate during use. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall REF:B12LT Ethicon Endo-Surgery, Inc Reusable access port system may crack or seperate during use. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall REF:B5LT Ethicon Endo-Surgery, Inc Reusable access port system may crack or seperate during use. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall REF:B5ST Ethicon Endo-Surgery, Inc Reusable access port system may crack or seperate during use. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Boston Scientific Corporation StoneSmart Connect Console Contents A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aisys, Datex-Ohmeda anesthesia system Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aisys CS2, Datex-Ohmeda anesthesia system Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and… Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154 Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5… Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AXLE PIN ASSY LARGE ELBOW COBALT CHROME Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OMNIFIT SERIES I ACET Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318… Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic… Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID… Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500… Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM… Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600… Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322… Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910… Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A Kits may exhibit open seals in sterile pouch packaging. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Maryland, North Carolina and Texas named
- Medical device recall Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F Kits may exhibit open seals in sterile pouch packaging. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Maryland, North Carolina and Texas named
- Medical device recall Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A Kits may exhibit open seals in sterile pouch packaging. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Maryland, North Carolina and Texas named
- Medical device recall Convenience kits CATARACT PACK DYNJ59881A Kits may exhibit open seals in sterile pouch packaging. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Maryland, North Carolina and Texas named
- Medical device recall Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907 Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Louisiana, Massachusetts, Maryland, Oklahoma, Texas and Vermont named
- Medical device recall CADD Yellow Medication Cassette Reservoir with NRFit connector US Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Class IIFDA’s classSep 23, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedSep 23, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Illinois, Indiana, Louisiana, Michigan, Missouri, Mississippi, Tennessee, Texas, Virginia and Wisconsin 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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