Medical device recalls

BMC Medical Co., Ltd. is reporting retroactive rework that was conducted on Luna G3 APAP devices at the 3B/React Health warehouse in 2024. This retroactive reporting involves approximately 20,160 units with specific serial numbers.

Serious·FDA·Aug 26, 2026·BMC Medical

Boston Scientific is recalling two ENROUTE Transcarotid Neuroprotection System products: the standard system (Material Number SR-200-NPS) and the Plus system (SR-250-NPS). The recall covers about 164,700 units, distributed in the US and to Australia, Canada, China and Jamaica. The arterial sheath tip may separate, fully or partially, during use. No injuries have been reported.

Serious·FDA·Aug 26, 2026·Boston Scientific2 products

Siemens is recalling two quinidine assay kits, the Syva EMIT 2000 and the Beckman Coulter Emit 2000, because certain lots may give falsely high quinidine measurements. Quinidine is a heart and antimalarial drug, so inaccurate results could lead to inappropriate treatment. The recall covers 75 units total and was distributed in California and Italy.

Serious·FDA·Aug 26, 2026·Siemens2 products

Beckman Coulter is recalling two products, DxC 500i and DxC 500 AU clinical analyzer modules, when they run software version 1.5 or lower. When a new Parameter Package is imported into an instrument that already has one, custom calculated test rules can silently revert to default settings, which may produce incorrect patient test results without an error message. New installations are not affected, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Beckman Coulter2 products

Paragon 28 is recalling two custom-made navicular cage foot implants because their oxygen level is above the allowed limit. Elevated oxygen may reduce the metal's ductility, meaning it may be less able to bend before breaking. The devices were distributed across the US, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Paragon 282 products

Gentherm Medical is recalling three thermal regulating system models, Blanketrol II Model 222S, Innercool Coolblue Console Model STx, and Blanketrol III Model 233, because the 115V CPU board can overheat and cause the device to shut down. The recall covers about 9,940 units distributed in the US nationwide, Puerto Rico, and several other countries. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Gentherm Medical3 products

A firmware defect in the KidneyVault datalogger may cause it to lose its configuration, resulting in a blank screen and inability to display organ preservation parameters. This affects 1,445 systems distributed across the US. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Paragonix

Certain lots of the Siemens Immulite 2000 Syphilis Screen diagnostic assay may incorrectly report low-level positive results as negative. This means some patients with syphilis could receive a false negative result, delaying diagnosis and treatment.

Serious·FDA·Aug 26, 2026·Siemens2 products

Halyard LAVH PACK surgical kits (Model USAR053-11) containing Clearify Visualization System components were sterilized using ethylene oxide (EO) in a way that did not follow manufacturer instructions. This improper sterilization may have caused a kit component to leak.

Moderate·FDA·Aug 26, 2026·AVID Medical

Getinge's Maquet Critical Care AB recalled nine Y Sensor modules (Model 6693662) for SERVO-U and SERVO-N ventilator systems. The modules did not complete electrical safety and functional tests during production. They were distributed to facilities in California, Georgia, Minnesota, and New York, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Maquet

Boston Scientific is recalling two Suture Cinch endoscopic tissue approximation devices, the OverStitch Suture Cinch and the Suture Cinch Long. The devices may fail to deploy the cinch implant or fail to cut the suture as intended. The recall covers 60,654 units of each product, distributed in the US and many other countries. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Boston Scientific2 products

Tobii Dynavox is recalling two TD Navio speech generating devices: the TD Navio Midi (model 1000798) and the TD Navio Maxi (model 1000799). Under certain conditions, the battery mounting tabs can become damaged, letting the battery move inside the device and possibly causing an internal short circuit, localized heating, and gas venting. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Tobii Dynavox2 products

Arrowhead DE LLC is recalling certain Arrow-LOK implants used to fix bones in the lesser toes after corrective surgery. The implants did not complete a required gamma radiation dose audit, which could reduce their sterility and potentially lead to patient infection. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Arrowhead

The ARVIS Surgical Navigation System Gen 2, a computer-controlled device used by surgeons to help position orthopedic implants during knee, hip, and shoulder surgery, has a sensor issue that can cause the image displayed through the eyepiece to appear tilted. This misalignment could affect the accuracy of surgical guidance if the surgeon relies solely on the displayed image without cross-checking with other alignment methods.

Moderate·FDA·Aug 26, 2026·Kico

The Philips Cardiac Workstation 5000 (Product Number 860439) can intermittently display inaccurate native heart rate data. This may affect the reliability of heart rate measurements used in clinical decision-making. The issue has been identified in approximately 796 units distributed worldwide.

Moderate·FDA·Aug 26, 2026·Philips2 products

Dentsply Sirona and SDI Limited are recalling about 1,444 Capsule Mixers, Model No. 5546068, with serial numbers in the 0003-1533 range. The units can release an electrical discharge when they are unplugged. The notice reports no injuries.

Moderate·FDA·Aug 26, 2026·SDI

Intersurgical is recalling two sizes of its One-Piece Guedel Airway, a device used to keep a patient's airway open. The devices could be blocked or partly blocked, and about 22,844 units are affected. They were distributed nationwide, with US distribution in CT, FL, IN, MI, OH, and VA, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Intersurgical2 products

Foundation Medicine's Protocol Configuration Tool (PCT) v2.0.0, used with Hamilton Microlab STAR liquid handlers to conduct F1CDx and F1LCDx tests, has a software issue that can cause the application to close unexpectedly. This affects 32 units distributed in Massachusetts and North Carolina.

Moderate·FDA·Aug 26, 2026·Foundation Medicine

The EndoFLIP endoscopic measuring system has a 24-hour usage limit that causes catheters to be incorrectly marked as expired. This prevents catheters from being used in clinical procedures even though they may still be suitable for use.

Moderate·FDA·Aug 26, 2026·Covidien

Spectral Instruments is recalling 75 units across two products: 40 Lago X and 35 Ami HTX. The on-screen "X-Ray On" banner can briefly be absent during the run readiness check. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Spectral Instruments2 products

BD Needle Kits used for emergency intraosseous (IO) access may have an obturator (the needle's internal plunger) that locks to the needle hub and becomes difficult or impossible to remove after placement. This locking is caused by out-of-tolerance manufacturing dimensions. If the obturator cannot be removed, a new needle may need to be placed, potentially delaying treatment.

Serious·FDA·Aug 26, 2026·Bard

Cardinal Health is recalling 8 Presource procedure kit product groups, sold under the Cardinal Health Presource Kits name, that contain MEDICOM Ritmed Neurological Sponges. The sponges had unexpected variability in endotoxin levels. The kits were distributed across the US and to Canada, and no injuries have been reported.

Moderate·FDA·Aug 19, 2026·Cardinal Health8 products

BD Switzerland SARL is recalling three intravenous extension and administration set models used to deliver fluids. The products may not have received adequate sterilization. The affected lots were distributed in 26 U.S. states and Canada, about 93,700 units in total, and no injuries have been reported.

Moderate·FDA·Aug 19, 2026·BD

Erbe USA is recalling certain ERBECRYO 2 cryosurgical units because a strong pull on the high-pressure transfer hose can cause CO2 to leak into the return path. The resulting excess pressure may rupture the cryoprobe. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Erbe

Bioporto Diagnostics recalled certain lots of the ProNephro AKI (NGAL) Reagent Kit, a test used to help detect acute kidney injury. The reagents were reworked using a process that had not been validated, which could lead to missed kidney disease, incorrect treatment decisions, or inappropriate monitoring. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Bioporto Diagnostics

BioFire Diagnostics is recalling certain lots of its BIOFIRE Respiratory Panel 2.1 (RP2.1) test, a lab test that detects respiratory infections. The company found an increase in false negative results, meaning the test can miss an infection that is actually present. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·BioFire Diagnostics

Straumann USA is recalling one lot of its Bone Level Tapered (BLT) dental implants, 14mm model, because some may actually be 12mm long, which does not match the label. The recall covers 175 units distributed nationwide, and no injuries have been reported.

Moderate·FDA·Aug 19, 2026·Straumann

Some Endo-Model replacement sets for a Rotating Hinge tibial plateau were packaged with a Pure Hinge plateau instead. The wrong plateau cannot be inserted, which could make surgery longer or require a different product. If it were implanted, it could wear faster and shorten how long the implant lasts. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Waldemar Link

OBP Medical is recalling certain lots of its ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small size, because the plastic blade may have a burr that could create a sharp edge. The edge could contact both the patient and the healthcare provider. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·OBP Medical

Philips is recalling certain Azurion interventional fluoroscopic X-ray systems, model numbers 722229 through 722236, running software versions R3.0 and R3.1. The software can degrade image quality, and it can also cause loss of geometry movements, which may delay treatment or complicate procedures. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Philips