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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Asserachrom HPIA Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Hawaii, Iowa, Massachusetts, Michigan, New Jersey, Nevada, New York, Ohio, Tennessee and Wisconsin named
- Medical device recall Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS Medline kits containing Stryker’s Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF Medline kits containing Stryker’s Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS Medline kits containing Stryker’s Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) ROBOTIC Medline kits containing Stryker’s Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE Medline kits containing Stryker’s Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE Medline kits containing Stryker’s Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Azurion Systems with software versions R2.1.10 and R2.2.10 Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Due to issues with the system’s stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ThinPrep¿ CytoLyt¿ Solution Fungal contamination of affected lot with Parengyodontium album. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Plum Duo Infusion System, List Number 40002-04-01 ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the… Potential for microbial contamination. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Minnesota, Mississippi, Nebraska, Ohio, Texas and Wisconsin named
- Medical device recall da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 Access Port System tray may develop cracks potentially resulting in a sterility breach. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Abre Venous Self-Expanding Stent System Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CentriMag Blood Pump Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in… Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Pulsator Arterial Blood Sampling Kit Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Washington named
- Medical device recall Portex Spinal Tray Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. Class IIFDA’s classJan 21, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJan 21, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Washington named
- Medical device recall The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient… Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall LUMINOS Lotus Max A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and… Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. Devices are not suitable for organ transplant. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 14, 2026ClassClass IStatusOngoingWhereNationwide, and Florida, Georgia and Puerto Rico named
- Medical device recall Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17. Devices are not suitable for organ transplant. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 14, 2026ClassClass IStatusOngoingWhereNationwide, and Florida, Georgia and Puerto Rico named
- Medical device recall Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 Devices are not suitable for organ transplant. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 14, 2026ClassClass IStatusOngoingWhereNationwide, and Florida, Georgia and Puerto Rico named
- Medical device recall Philips Incisive CT Potential for incomplete scan due to unstable connection inside of floating sensor. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated… Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Indiana, Maine, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Washington and West Virginia named
- Medical device recall Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereCalifornia, Maine and Michigan
- Medical device recall Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog… The affected lots show a decline in performance over time, which may lead to false-negative results. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beckman Coulter UniCel Dxl 600 Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard… Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Beckman Coulter UniCel Dxl 800 Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard… Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Tempus Pro Patient Monitor Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, 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, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BD Pyxis ES Enterprise Server Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJan 14, 2026ClassClass 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
- Medical device recall The Pressio 2 ICP Monitoring System Customer complaints of Pressio monitor rebooting. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Idaho, New Jersey, Oklahoma, Oregon, Texas and Wisconsin named
- Medical device recall Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. Device packaged in incorrect outer box carton. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Arial 900 MHz Call Station Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1)… Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Arial 900 MHz Call Station Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1)… Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Smart-hopping 2.0 AP 1.4 GHz It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength… Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Torque screw may crack or separate. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY Firm received multiple complaints regarding tubing disconnecting from oxygen mask. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Codman Microsensor Basic Kit Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide, and 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 Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Codman CereLink ICP Sensor Basic Kit Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. Class IIFDA’s classJan 14, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedJan 14, 2026ClassClass IIStatusOngoingWhereNationwide, and 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 Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Material Processing Laser Products Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3) Class IIFDA’s classJan 7, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 7, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly. Class IIFDA’s classJan 7, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 7, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Butyrate tube cracks during actuation, rendering product unusable. Class IIFDA’s classJan 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 7, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8”D Tapered to 2.9”W x 11.8”L Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. Class IIFDA’s classJan 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Washington named
- Medical device recall Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer. Class IIFDA’s classJan 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJan 7, 2026ClassClass IIStatusCompletedWhereNationwide, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BVI Leos Laser and Endoscopy System Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not… Class IIFDA’s classJan 7, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJan 7, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Michigan, Oklahoma, Texas 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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