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 7, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall MIM software In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV)… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and… The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Illinois named
- Medical device recall CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056) The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Illinois named
- Medical device recall Philips Connected Blood Glucose Meter, BGM 4 Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name)… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a… Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall (1) Lumenis Pulse 120H 30 amp The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMar 12, 2025ClassClass IIStatusOngoingWherePennsylvania
- Medical device recall DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal… Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereIllinois, Minnesota, North Carolina, Pennsylvania and Virginia
- Medical device recall Vios Monitoring System Bedside Monitor Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Louisiana, Maryland, Montana, New York, Ohio and Texas named
- Medical device recall Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45,… Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, Florida, Maryland, Minnesota, North Carolina, Nebraska, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties… Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Louisiana, Oklahoma and Tennessee named
- Medical device recall AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager Possibility for the obturator to break (separate). Class IIFDA’s classMar 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 12, 2025ClassClass IIStatusOngoingWhereNationwide, and California, District of Columbia, Florida, Illinois, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Washington named
- Medical device recall BD BBL TB Stain Kit K One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025. Class IIFDA’s classMar 12, 2025in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 12, 2025ClassClass IIStatusOngoingWhereArizona, California, Colorado, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, North Carolina, New Jersey, New York, Texas and Washington
- Medical device recall VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English) Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 5, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 5, 2025ClassClass IStatusOngoingWhereCalifornia, Missouri and New York
- Medical device recall BD Pyxis: MedFlex Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in… Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 5, 2025ClassClass 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Pyxis MedFlex 2.0 Due to fingerprint scanner failing resulting in the scanner heating up. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, 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, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall IntelePACS (Image Fusion Module) - InteleViewer A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard… Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Hampshire, New Jersey, Ohio, South Carolina, Tennessee, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left.… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of fractures… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of… Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS… Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 5, 2025ClassClass 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI… Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 5, 2025ClassClass 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS… Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 5, 2025ClassClass 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS… Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 5, 2025ClassClass 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Alaris Pump Module Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement Report51 statesnamed in where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereAlaska, 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, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest. Incorrect keypad was incorrectly installed onto a defibrillator/monitor. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportWest Virginiathe one state its words name PublishedMar 5, 2025ClassClass IIStatusOngoingWhereWest Virginia
- Medical device recall DxC 500 AU Clinical Chemistry Analyzer Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for… Class IIFDA’s classMar 5, 2025in FDA’s Enforcement Report19 statesnamed in where it went PublishedMar 5, 2025ClassClass IIStatusOngoingWhereAlabama, California, Colorado, Georgia, Idaho, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas and Washington
- Medical device recall Socrates 38 Aspiration Catheter 127 cm length Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Minnesota, North Carolina, New Jersey, New York, Pennsylvania, South Dakota, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Plato 17 Microcatheter Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. Class IIFDA’s classMar 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Delaware 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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