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 5, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight Potential for the outer stainless-steel tube to break or detach. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long Potential for the outer stainless-steel tube to break or detach. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Accutome/Microsurgical Disposable Bipolar Pencil 5 in. Potential for the outer stainless-steel tube to break or detach. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Ambler Surgical Bipolar Pencil 25 Gauge Straight Potential for the outer stainless-steel tube to break or detach. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Walcott Bipolar Pencil 25 Gauge Straight Potential for the outer stainless-steel tube to break or detach. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description:… Potential for the outer stainless-steel tube to break or detach. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Optikon Bipolar Pencil 25 Gauge Straight Potential for the outer stainless-steel tube to break or detach. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER… Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636… Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2024ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Brand Name: Atlan Product Name: Atlan A300 The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Brand Name: Atlan Product Name: Atlan A300XL The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2024ClassClass IStatusOngoingWhereNo state named
- Medical device recall Turbo Elite Laser Atherectomy Catheter Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report47 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record… Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report22 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Delaware, Florida, Louisiana, Massachusetts, Michigan, Minnesota, Montana, North Carolina, Nebraska, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Eclipse Mini Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report22 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Delaware, Florida, Louisiana, Massachusetts, Michigan, Minnesota, Montana, North Carolina, Nebraska, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Philips Smart-Hopping 2.0 AP 1.4 GHz The following four issues are included: 1. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: K-Systems Product Name: G73 Dry Bath Incubator The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Pennsylvania, Texas and Virginia
- Medical device recall Brand Name: K-Systems Product Name: G85 Mini Incubator The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Pennsylvania, Texas and Virginia
- Medical device recall Brand Name: K-Systems Product Name: T47 Warming Plate The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Pennsylvania, Texas and Virginia
- Medical device recall Brand Name: K-Systems Product Name: T47 Warming Plate The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Pennsylvania, Texas and Virginia
- Medical device recall Brand Name: K-Systems Product Name: R65 Trolley The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Pennsylvania, Texas and Virginia
- Medical device recall Brand Name: K-Systems Product Name: Multiple/unknown The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereCalifornia, Illinois, North Carolina, New Jersey, New York, Pennsylvania, Texas and Virginia
- Medical device recall Galaxy System (GAL-001) Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden,… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report16 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Idaho, Illinois, Indiana, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Virginia and West Virginia
- Medical device recall HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient’s… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient’s… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient’s… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient’s… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Augustine Surgical Inc Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Augustine Surgical Inc Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Hillrom Temperature Management Controller, MP Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm… Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report45 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to… Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report45 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy… Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report45 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide… Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report45 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Duravent Silicone Ventilation Tube Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement Report18 statesnamed in where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Illinois, Kentucky, Maryland, Minnesota, Missouri, North Carolina, North Dakota, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin
- Medical device recall mint Lesion, Software Versions: 3.9.0 through 3.9.5. Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Michigan, Minnesota, New York, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall mint Lesion, Software Versions: 3.10.0 and 3.10.1. Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Michigan, Minnesota, New York, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin named
- Medical device recall DKS Disposable Kerrison System Units were not intended for commercial distribution and inadvertently distributed. Class IIFDA’s classDec 18, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereKansas, Louisiana, Michigan, New York and Texas
- Medical device recall Small DKS Disposable Kerrison System Units were not intended for commercial distribution and inadvertently distributed. Class IIFDA’s classDec 18, 2024in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereKansas, Louisiana, Michigan, New York and Texas
- Medical device recall ChemoLock Close Vial Spike Due to finished goods incorrectly packaged and labeled. Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Illinois named
- Medical device recall Microscissor Tip (Disposable) A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off. Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Oklahoma named
- Medical device recall MICRO-X Rover Mobile X-ray System, # MXU-RV35 Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations… Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and California, New Jersey and Puerto Rico named
- Medical device recall MICRO-X Rover Mobile X-ray System, # MXU-RV35 Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator. Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and California, New Jersey and Puerto Rico named
- Medical device recall MICRO-X Rover Mobile X-ray System, # MXU-RV19 During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the… Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Idaho, Ohio, Texas and Washington named
- Medical device recall Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusCompletedWhereNationwide
- Medical device recall BD Pyxis MedStation ES Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect… Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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, West Virginia and Wyoming named
- Medical device recall BD Pyxis MedStation ES 7 Drawer Auxiliary Tower Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect… Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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, West Virginia and Wyoming named
- Medical device recall BD Pyxis CII Safe ES Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect… Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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, West Virginia and Wyoming 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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