FDA Updates

Every medical device recall the FDA publishes, pulled live from openFDA's Device Recall database - the same records behind the FDA's own recall pages. No manual sync: this page re-fetches on its own, so a recall shows up here as soon as the FDA posts it. Not filtered to devices in our catalog.

openFDA last refreshed this dataset on September 3, 2026. New recalls appear here on the FDA's own publishing schedule.

59,102 recall(s)

Open, ClassifiedPosted Jul 22, 2026·Initiated Jun 19, 2026

Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.

Reason: Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.

Root cause: Device Design

Recalling firm: Boston Scientific CorporationType: System, Image Processing, RadiologicalDistribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, LA, MA, MN, NE, NY, OH, OK, OR, SC, SD, TN, TX, UT, WA, WI, WV, WY.Recall #Z-2771-2026

Open, ClassifiedPosted Jul 22, 2026·Initiated May 19, 2026

Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.

Reason: Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.

Root cause: Process change control

Recalling firm: AVID Medical, Inc.Type: Cardiac Catheterization KitDistribution: U.S. Nationwide distribution in the state of California.Recall #Z-2772-2026

Open, ClassifiedPosted Jul 22, 2026·Initiated Jun 8, 2026

Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12

Reason: Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.

Root cause: Labeling Change Control

Recalling firm: Micro Therapeutics, Inc.Type: Intracranial Aneurysm Flow DiverterDistribution: US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.Recall #Z-2773-2026

Open, ClassifiedPosted Jul 22, 2026·Initiated Jun 8, 2026

Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20

Reason: Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.

Root cause: Labeling Change Control

Open, ClassifiedPosted Jul 22, 2026·Initiated Jun 30, 2026

SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.

Reason: The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.

Root cause: Software design

Recalling firm: KENT IMAGING, INC.Type: Autofluorescence Imaging Adjunct Tool For WoundsDistribution: US Nationwide distribution in the states of PA, IA, FL, TX, GA, NV, CA, UT, IN, DC, KS, IL, TN, AR, AZ.Recall #Z-2775-2026

Open, ClassifiedPosted Jul 22, 2026·Initiated Jun 16, 2026

Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Reason: Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Root cause: Nonconforming Material/Component

Recalling firm: Olympus Corporation of the AmericasType: Insufflator, LaparoscopicDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Germany, Honduras, Hong Kong, India, Ireland, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Paraguay, Peru, Russia, Singapore, Sri Lanka, Taiwan, Thailand, United Kingdom, Uruguay, Vietnam.Recall #Z-2776-2026

Open, ClassifiedPosted Jul 22, 2026·Initiated May 29, 2026

Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volume from the acoustic signal of urination. No physical components. Distributed digitally via mobile application.

Reason: Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was therefore processed against a time/frequency scale the models did not expect, producing systematically biased Qmax, Qmean, and voided-volume estimates. The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams.

Root cause: Software Design Change

Recalling firm: Emano Metrics, Inc.Type: UroflowmeterDistribution: U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.Recall #Z-2777-2026

Open, ClassifiedPosted Jul 21, 2026·Initiated Apr 6, 2026

The intended use is to be paired with a weapon for aiming purposes.

Reason: Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.

Root cause: Radiation Control for Health and Safety Act

Recalling firm: Wilcox Industries Corp.Type: Laser Aiming Product, VisibleDistribution: US Nationwide distribution in the state of NH.Recall #Z-2675-2026

Open, ClassifiedPosted Jul 21, 2026·Initiated May 7, 2026

3mensio Workstation (Vascular Fenestrated) software

Reason: User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information

Root cause: Software change control

Recalling firm: PIE Medical Imaging B.V.Type: Automated Radiological Image Processing SoftwareDistribution: Worldwide - US Nationwide distribution in the states of CA, NY, MN, MI, TX and the countries of United Kingdom, Australia, France, Italy, Hong Kong SAR, Thailand, Taiwan, Netherlands, Ireland, Spain, Greece, Japan, Belgium.Recall #Z-2767-2026

Open, ClassifiedPosted Jul 21, 2026·Initiated Jun 17, 2026

Ventriculostomy Kit, REF: 46154

Reason: Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.

Root cause: Process control

Recalling firm: Medtronic NeurosurgeryType: Drills, Burrs, Trephines & Accessories (Manual)Distribution: Worldwide - US Nationwide distribution in the states of UT, AL, CA, NC, GA, AR, LA, KY, LA, KY, IL, OK and the country of Costa Rica.Recall #Z-2768-2026

Open, ClassifiedPosted Jul 21, 2026·Initiated Apr 27, 2026

Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA).

Reason: Due to device not having FDA Clearance

Root cause: Process control

Recalling firm: Prismatik Dentalcraft, Inc.Type: Device, Anti-SnoringDistribution: U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.Recall #Z-2769-2026

Open, ClassifiedPosted Jul 21, 2026·Initiated Jun 3, 2026

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Reason: Due to manufacturing issues, reperfusion catheters may fractures

Root cause: Under Investigation by firm

Recalling firm: Penumbra, Inc.Type: Catheter, Thrombus RetrieverDistribution: Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates.Recall #Z-2770-2026

Open, ClassifiedPosted Jul 20, 2026·Initiated Jun 11, 2026

FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01

Reason: Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.

Root cause: Use error

Recalling firm: Boston Scientific CorporationType: Catheter, SteerableDistribution: Global Distribution. US Nationwide.Recall #Z-2754-2026

Open, ClassifiedPosted Jul 20, 2026·Initiated Jun 11, 2026

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062

Root cause: Use error

Recalling firm: Boston Scientific CorporationType: Catheter, SteerableDistribution: Global Distribution. US Nationwide.Recall #Z-2755-2026

Open, ClassifiedPosted Jul 20, 2026·Initiated Jun 11, 2026

FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01

Root cause: Use error

Recalling firm: Boston Scientific CorporationType: Catheter, SteerableDistribution: Global Distribution. US Nationwide.Recall #Z-2756-2026

Open, ClassifiedPosted Jul 20, 2026·Initiated Jun 11, 2026

FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01

Root cause: Use error

Recalling firm: Boston Scientific CorporationType: Catheter, SteerableDistribution: Global Distribution. US Nationwide.Recall #Z-2757-2026

Open, ClassifiedPosted Jul 20, 2026·Initiated Jul 7, 2026

Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.

Reason: Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.

Root cause: Nonconforming Material/Component

Recalling firm: Olympus Corporation of the AmericasType: Laparoscope, General & Plastic SurgeryDistribution: Worldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the country of Japan.Recall #Z-2761-2026

Open, ClassifiedPosted Jul 20, 2026·Initiated May 28, 2026

SeaSpine Polyaxial Head REF Number: 41-3010

Reason: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Root cause: Process change control

Recalling firm: SEASPINE ORTHOPEDICS CORPORATIONType: Thoracolumbosacral Pedicle Screw SystemDistribution: Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Mississippi, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wyoming. The countries of Chile and Australia.Recall #Z-2762-2026

Open, ClassifiedPosted Jul 20, 2026·Initiated May 7, 2026

Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.

Reason: Incorrect concentration of Betadine solution contained within certain AVID convenience kits.

Root cause: Process control

Recalling firm: AVID Medical, Inc.Type: Eye TrayDistribution: US Nationwide distribution in the state of California.Recall #Z-2763-2026

Open, ClassifiedPosted Jul 17, 2026·Initiated Jun 11, 2026

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

Reason: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Root cause: Under Investigation by firm

Recalling firm: Boston Scientific CorporationType: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationDistribution: International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.Recall #Z-2750-2026