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 6, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall BD Pyxis Pro MedStation Main Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall All Serial Numbers/BD Pyxis CII Safe ES Tower Main Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Model: Incisive CT Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Virginia
- Medical device recall Model: CT 5300 Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Virginia
- Medical device recall Model: Incisive CT for Brazil SKD Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Michigan, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah and Virginia
- Medical device recall Ivenix Infusion System (IIS), Large Volume Pump Potential issue that can cause the device to register “phantom” touches in the lower-left corner of the touchscreen during operation. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Minnesota named
- Medical device recall 9 Coated Super Tampons and 9 Nude Super Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 9 Coated Regular Tampons and 9 Nude Regular Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 18 Coated Regular Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 18 Coated Super Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 9 Coated Regular and 9 Coated Super Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 9 Coated Regular and 9 Nude Regular Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 9 Coated Super and 9 Nude Super Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Trial Tampon Box Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall All in One Bundle Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Regular Flow Bundle Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Heavy Flow Bundle Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refill 36 Coated Regular Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refill 36 Coated Super Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refill 18 Coated Regular and 18 Coated Super Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refill 18 Coated Regular and 18 Nude Regular Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refill 18 Coated Super and 18 Nude Super Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refill 3 Month Trial Tampon Box Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refill 3 Month All in One Bundle Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refill 3 Month Regular Flow Bundle Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refill 3 Month Heavy Flow Bundle Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Initiation 36 Coated Regular Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Initiation 36 Coated Super Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Initiation 18 Coated Regular and 18 Coated Super Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Initiation 18 Coated Regular and 18 Nude Regular Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Initiation 18 Coated Super and 18 Nude Super Tampons Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Initiation 3 Month Trial Tampon Box Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Initiation 3 Month All in One Bundle Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Initiation 3 Month Regular Flow Bundle Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Initiation 3 Month Heavy Flow Bundle Product lacks 510(k) clearance. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2% Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sharesource Connectivity Platform for Use with Homechoice Claria Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 5, 2025ClassClass IIStatusOngoingWhereColorado, Michigan, Minnesota, Tennessee and Texas
- Medical device recall MST ArcDUO 9mm An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall CellMek SPS Sample Preparation System Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes:… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Florida, Illinois, Indiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, New York, Oregon, Tennessee, Utah and Washington named
- Medical device recall Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading… Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Kentucky, North Carolina, New York, Ohio and Virginia named
- Medical device recall Xpert SA Nasal Complete As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. Class IIFDA’s classNov 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Georgia, Idaho, Illinois, Louisiana, New Hampshire, New York, Oklahoma, Texas, Utah and Wisconsin named
- Medical device recall Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Automated Impella Controller (AIC) labeled as the following with corresponding Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall IV Administration sets. 23” IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 29, 2025ClassClass IStatusOngoingWhereNationwide, and South Carolina and Texas named
- Medical device recall Salem Sump PVC Tubes Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 29, 2025ClassClass 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, 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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