Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI’s… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI’s… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI’s… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Philips Azurion 7M20 systems with FlexArm ceiling-mounted system The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report28 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maryland, Minnesota, Missouri, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System Potential for anesthesia leakage. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Kentucky, Maryland, Missouri, Mississippi, New Jersey, Puerto Rico, Texas, Washington and West Virginia named
- Medical device recall Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System Potential for anesthesia leakage. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Kentucky, Maryland, Missouri, Mississippi, New Jersey, Puerto Rico, Texas, Washington and West Virginia named
- Medical device recall Cold Form Wrap: Back The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap… Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall IntelePACS - InteleConnect / TechPortal Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause… Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Illinois, Indiana, Maryland, North Carolina, New Jersey, Tennessee and Washington named
- Medical device recall Xpert MTB/RIF Product testing did not meet expected stability criteria. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall BD Alaris infusion Pump Module 8100 If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 26, 2025ClassClass IStatusOngoingWhereNationwide, and American Samoa, Guam, Northern Mariana Islands and Puerto Rico named
- Medical device recall TMJ Bilateral Implant Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 26, 2025in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 26, 2025ClassClass IStatusOngoingWhereCalifornia, Florida, Georgia, Illinois, Massachusetts, Maryland, Minnesota, Mississippi, New York, Oklahoma, Oregon, Pennsylvania, Texas, Utah and Virginia
- Medical device recall MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI… When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended… Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide, and New Mexico named
- Medical device recall BD Luer Tip Caps BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall MC3 VitalFlow Console As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE STERILE BASIC EYE PACK 16: 1) Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportMissourithe one state its words name PublishedNov 26, 2025ClassClass IIStatusOngoingWhereMissouri
- Medical device recall MEDLINE convenience kits labeled as LOCAL BASIC Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) HEAD AND NECK Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: PORT INSERTION PACK Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: CIRCUMCISION PACK Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: GP-LEEP PACK-LF Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PhD Hemostasis Valve Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure… Class IIFDA’s classNov 26, 2025in FDA’s Enforcement Report49 statesnamed in where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereAlaska, 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, Washington, Wisconsin and West Virginia
- Medical device recall Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Due to distributing the measles IgG IVD without a premarket approved/cleared. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 26, 2025ClassClass IIStatusOngoingWhereUtah and Washington
- Medical device recall Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Due to products that have not completed design updates and performance testing being released/distributed. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedNov 26, 2025ClassClass IIStatusOngoingWhereSouth Carolina
- Medical device recall Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Due to products that have not completed design updates and performance testing being released/distributed. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedNov 26, 2025ClassClass IIStatusOngoingWhereSouth Carolina
- Medical device recall Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Due to products that have not completed design updates and performance testing being released/distributed. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedNov 26, 2025ClassClass IIStatusOngoingWhereSouth Carolina
- Medical device recall OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT… A labeling error was identified on the affected product. Class IIIFDA’s classNov 26, 2025in FDA’s Enforcement Report47 statesnamed in where it went PublishedNov 26, 2025ClassClass IIIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Medtronic HR-ACT (High Range Activated Clotting Time Cartridges) Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges. Class IIFDA’s classNov 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Hawaii and New York 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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