Medical device recalls

Beckman Coulter Biomedical GmbH is recalling REMISOL Advance Data Manager software version 2.5 because it does not handle combo assay results correctly. The software may replace a final combo test result with one of its sub-results, which could lead to incorrect reporting of test outcomes. No injuries have been reported, and the notice covers 20 systems distributed in the U.S. and abroad.

Moderate·FDA·Aug 12, 2026·Beckman Coulter

AVID Medical is recalling three Halyard convenience kits that contain Medline Namic Angiographic Star Off Handle Manifolds, which the manufacturer recalled because of particulates in the fluid path. The particulates could enter the bloodstream and become lodged in blood vessels. The notice lists about 5,168 affected kits for each of the three products, with distribution in the US, including NC and TX.

Serious·FDA·Aug 12, 2026·AVID Medical3 products

Medline Industries recalled Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits because the electrical connector at the Neptune humidifier can overheat, causing discoloration, melting, smoke, or burning. When this happens, the device automatically shuts off the heated wire function, which means infants may receive unheated or unconditioned breathing gas that can damage the airway and increase the risk of respiratory complications.

Moderate·FDA·Aug 5, 2026·Medline

BD is recalling specific lots of its Intraosseous Vascular Access System Needle Sets because some users have had difficulty removing the obturator (stylet) after needle placement. The affected needle sets were manufactured with out-of-tolerance dimensions and distributed between September 2024 and June 2026. If the obturator cannot be removed, clinicians may need to obtain alternative vascular access, potentially delaying urgent care.

Serious·FDA·Jul 30, 2026·BD

Karl Storz Flexible Hystero-Fiberscope Kits with certain serial numbers contain expired single-use endoscopic seals that may not maintain sterility during gynecological procedures. The affected seals expired in January 2023 and were distributed across 15 U.S. states.

Moderate·FDA·Jul 29, 2026·Karl Storz

The SafeOp Patient Interface (REF: AIX11240), part of the SafeOp 3 Neural Informatix System used during spine surgery, can lose or drop its nerve monitoring signal due to a software problem. When this happens, the device may show system errors, lose connection to the surgeon's tablet, and require a restart—potentially extending surgery time or changing the surgical plan.

Moderate·FDA·Jul 29, 2026·Alphatec Spine

Medline is recalling specific medical convenience kits that include BD PurPrep 26 mL antiseptic skin prep. The prep may contain low levels of Bacillus bacteria. The recall covers four product listings, and no injuries have been reported.

Moderate·FDA·Jul 29, 2026·Medline4 products

Medline is recalling nine urology convenience kits that contain Bard Silastic Foley catheters. The catheter maker recalled them because they have higher than intended amounts of raw material on the surface, which can cause staining and may be harmful. The kits were distributed nationwide, with confirmed distribution in California, Florida, Maryland, Pennsylvania, and Texas, and no injuries have been reported.

Moderate·FDA·Jul 29, 2026·Medline9 products

Medtronic MiniMed Go app versions 1.0.0 and 1.1.0 have a software bug: when the "Set day and night" feature is turned off, missed-dose and high-glucose alerts may fail to trigger at night. This means users may not realize they've missed insulin doses, potentially delaying treatment and raising blood sugar levels dangerously.

Moderate·FDA·Jul 29, 2026·Medtronic

Emano Flow, a smartphone app that measures urinary flow rate and volume, produced inaccurate results during a two-month period (March 22–May 29, 2026). The app recorded audio at an incorrect frequency setting, causing measurements to be systematically over-reported. The company has provided corrected results to healthcare teams.

Moderate·FDA·Jul 29, 2026·Emano Metrics

The Olympus UHI-4 insufflation unit may experience unexpected shutdowns where the front panel display turns off and air delivery stops during use. This affects about 3,087 units distributed worldwide. No injuries have been reported.

Moderate·FDA·Jul 29, 2026·Olympus

The SnapshotGLO device's software cannot recognize when its battery has fully discharged into a low-power shipping mode. When this happens, the device will not resume charging when plugged in and becomes temporarily unusable until the issue is corrected.

Moderate·FDA·Jul 29, 2026·Kent Imaging

Micro Therapeutics Pipeline Flex Embolization Devices have incorrect labeling on some units. Devices labeled as 3.0 mm x 20 mm actually contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm actually contain 20 mm implants. This mismatch could lead to incorrect implant selection during surgery.

Moderate·FDA·Jul 29, 2026·Micro Therapeutics2 products

Certain Halyard STANDARD LINE INSERTION PACK kits (Model PVHM234-01) have a defect in the silicone seal that may not seal properly. This defect can cause the seal to dome inward, potentially blocking fluid flow or allowing fluid to leak where it shouldn't.

Moderate·FDA·Jul 29, 2026·AVID Medical

The TheraSphere 360 Y-90 Management Platform has a software bug that can cause incorrect dose calculations. When a user modifies calculation inputs and recalculates, the new dose is computed correctly on screen, but vials previously added to the cart do not automatically update to match the revised calculation.

Moderate·FDA·Jul 29, 2026·Boston Scientific

Penumbra System RED 68 Reperfusion Catheters (REF: RED68KIT) may fracture during use due to a manufacturing defect. The affected lots are H00008699, H00008701, H00008702, H00008703, and C00020038. These catheters were distributed worldwide, including throughout the United States.

Serious·FDA·Jul 29, 2026·Penumbra

Prismatik Dentalcraft distributed Silent Nite Sleep Appliances (a mandibular advancement device for snoring and sleep apnea) without obtaining required FDA clearance. The devices were sold in multiple states before the clearance status was identified.

Moderate·FDA·Jul 29, 2026·Prismatik Dentalcraft

Medtronic Neurosurgery's Ventriculostomy Kit (REF: 46154) may contain endotoxin levels higher than safe limits for devices that contact cerebrospinal fluid during brain surgery. Endotoxin exposure can trigger acute inflammation in the brain and nervous system.

Moderate·FDA·Jul 29, 2026·Medtronic

The 3mensio Workstation software may report heart and vessel measurements that are 0.8% to 34% larger than the actual size when specific conditions are met: the software is used with access only to 3D Echo or Mitral 3D Echo features, and the analysis involves Philips 3D echo datasets that contain Color Doppler data. This could lead to incorrect clinical measurements used in patient care decisions.

Moderate·FDA·Jul 29, 2026·PIE Medical Imaging

Medline is recalling 370 medical procedure convenience kits across two product entries. The kits include pain management kits made by ICU Medical that contain bupivacaine hydrochloride in dextrose injection, which was recalled over quality issues that could make the drug less effective. No injuries have been reported, and the kits were distributed in Missouri, Colorado, and Illinois.

Serious·FDA·Jul 29, 2026·Medline2 products

Certain Halyard EYE PACK convenience kits (Model LVEY27) contain Betadine solution at an incorrect concentration. The kits were distributed nationwide, primarily in California. No injuries have been reported.

Moderate·FDA·Jul 29, 2026·AVID Medical

SeaSpine Orthopedics has recalled certain Polyaxial Head spinal implants (REF 41-3010) due to a manufacturing error that may cause the polyaxial head to detach from the screw during surgery after insertion. This could require additional surgical intervention. The recall affects 796 units distributed worldwide, including nationwide US distribution and locations in Chile and Australia.

Moderate·FDA·Jul 29, 2026·SeaSpine

Olympus has identified a potential fault in the HDMI and DisplayPort connectors on certain OEV321UH 4K UHD LCD Monitors. This fault can result in image loss or display abnormalities. The recall affects 10 units with specific serial numbers distributed in Ohio, California, New Jersey, Florida, and Japan.

Moderate·FDA·Jul 29, 2026·Olympus

The roller assembly on the Ferno-Washington Power F2 Powered Fastening System may wear unevenly and deform, causing the rail mechanism to jam. If this happens, the stretcher cannot move along the rail—either with the powered system or manually—potentially delaying patient transport to a hospital.

Moderate·FDA·Jul 29, 2026·Ferno

ICU Medical's Hotline Fluid Warming Set (model L-70), a single-use device used to warm blood and IV fluids before delivery to patients, may leak due to inadequate solvent application at the tubing-to-connector bond in certain production lots. This defect could affect proper fluid delivery during patient care.

Moderate·FDA·Jul 29, 2026·ICU Medical

Paragon 28 received two complaints about breaches in the sterile barrier packaging of specific lots of the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (0.30 mm, 800 mm). The packaging breach could potentially allow contamination of the surgical device before use. No injuries have been reported.

Moderate·FDA·Jul 29, 2026·Paragon 28

Boston Scientific found that some air leak complaints were linked to damage to the sheath's hemostatic valve. The damage can happen when the dilator is inserted at the wrong angle during setup, and it may allow air into the device, creating a potential air embolism. This recall covers four FARADRIVE steerable sheath versions, with about 776,000 units affected. No injuries have been reported.

Moderate·FDA·Jul 29, 2026·Boston Scientific4 products

Boston Scientific identified specific FARASTAR Pulsed Field Ablation (PFA) generators with a configuration that cannot work safely with the FARAPOINT PFA catheter. Six units with specific serial numbers were distributed across Europe and need to be replaced.

Moderate·FDA·Jul 29, 2026·Boston Scientific

Boston Scientific is recalling three FARASTAR pulsed field ablation generator products because the instructions for use shipped with them did not include information about the FARAPOINT PFA catheter. A total of 30 units were affected, distributed in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, and Ireland. No injuries have been reported.

Moderate·FDA·Jul 29, 2026·Boston Scientific3 products

Medline is recalling three kit products that contain a bupivacaine hydrochloride injection, a numbing medication used in surgery. The bupivacaine maker issued a voluntary recall over quality issues, so Medline is recalling the kits that include it. About 2,417 kits are affected, distributed in OH, CA, IL, IN, FL, SC, AZ, and NJ.

Serious·FDA·Jul 29, 2026·Medline3 products