Medical device recalls

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

Philips is recalling certain Azurion interventional fluoroscopic X-ray systems running software version R2.2.10. The software can degrade image quality or cause a loss of geometry movements, which may delay treatment or lead to procedural complications. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Philips

Terumo Medical Corporation is recalling certain GlideSheath Slender A-Kit 6F 10cm .021GW kits (Product Code 60-1060) because they were packaged with a 0.025 guidewire instead of the labeled 0.021 guidewire. The kit is used to help place a catheter through the skin into the radial artery. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Terumo

Straumann USA is recalling certain GM Helix dental implants (Article No. 109.984, Lot MVXJ9) because the implant inside the package may not match the outer carton label. If the wrong implant is placed, it could cause bone compression or make installation difficult where there is sufficient bone. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Straumann

Philips Medical Systems recalled certain Allura Xper FD interventional fluoroscopic X-ray systems, affecting about 4,252 units. A firmware problem may cause the system to lose some geometry movements. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Philips

Certain lots of the Remel (Thermo Fisher Diagnostics) Neisseria meningitidis Group C 2 mL test, product R30166901, did not perform as its instructions require. The test did not return a positive result with a reference control strain within 60 seconds. About 26 units were distributed nationwide, and no injuries have been reported.

Moderate·FDA·Aug 19, 2026·Remel

Medline is recalling four sizes of Micro-Kill Bleach Germicidal Bleach Wipes, about 1.07 million units in total. The bleach concentration in the wipes may drop below the labeled level before the 12-month shelf life ends, which could reduce their ability to kill germs.

Moderate·FDA·Aug 19, 2026·Medline4 products

Covidien is recalling five surgical suture products, including V-Loc 90, V-Loc 180, Dermalon, Surgipro and Surgipro II, with about 135,875 units affected. The sterile packaging may have a tear or hole, which could let germs reach the sutures and cause infection, prolonged surgery, or vision loss if used in eye surgery. The recall covers the US and many other countries, and no injuries have been reported.

Moderate·FDA·Aug 19, 2026·Covidien5 products

Black depth markings on the outer sheath of the coaxial dilator introducer in certain Boston Scientific Enhance transcarotid and peripheral access kits may detach. The recall covers about 114,260 kits across many lot numbers. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Galt Medical

Spacelabs Healthcare is recalling about 6,074 Xhibit Central Station units, model 96102, which are used to remotely monitor patient data. The recall involves a third-party DisplayPort audio/video splitter that can fail, interrupting audio and video output to extra displays. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Spacelabs Healthcare

Some GORE VIABIL Short Wire Biliary Endoprosthesis devices labeled as model VSWVN1010 (10 mm by 10 cm, without transmural drainage holes) are actually model VSWVH1006 (10 mm by 7 cm, with transmural drainage holes). The recall covers 13 units, sold in Georgia and Rhode Island, and no injuries have been reported. The device is used to keep the common bile duct open when it is blocked.

Moderate·FDA·Aug 19, 2026·Gore2 products

Ventana Medical Systems is recalling navify Digital Pathology software, version 2.5, used with the Roche Digital Pathology Dx slide imaging system. Customers reported that images did not match their information (metadata) in the viewer window. No injuries have been reported.

Moderate·FDA·Aug 19, 2026·Ventana Medical Systems

MicroVention is recalling certain BOBBY Balloon Guide Catheters because the balloons may develop pinhole defects, which occur at an increased rate. The catheter is used by health care providers to guide a catheter into blood vessels during peripheral and neurovascular procedures. The FDA has classified the recall as Class II, and no injuries have been reported.

Moderate·FDA·Aug 19, 2026·Microvention

Spectra Medical Devices is recalling its 0.9% Sodium Chloride Injection 10mL ampules (model AMPUL10MLK), used as flushes in IV tubing and indwelling access devices. The manufacturer, Huons, was cited for product quality and sterility problems. If sterility is compromised, patients could be exposed to microorganisms, endotoxins, or foreign matter, which may cause infections, inflammation, or micro-clots.

Serious·FDA·Aug 19, 2026·Spectra Medical Devices

Baxter Healthcare is recalling certain Duo-Vent solution sets (product code 1C8507) because air bubbles can form in the drip chamber and tubing. Customers reported this happening when a pressure cuff was in use or when the tubing was flushed with the clamp fully open. About 24,528 units were distributed nationwide, and no injuries have been reported.

Serious·FDA·Aug 19, 2026·Baxter

The Neuroguard IEP carotid stent and post-dilation balloon system has an integrated filter that may fail to open after the sheath is retracted, due to a wire-to-filter bond issue. If this happens during a procedure, the device may lose its intended embolic protection. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Contego Medical

Freudenberg Medical is recalling two Blom-Singer Classic Indwelling Voice Prosthesis products (16Fr/10 mm, REF 1610-LEF and 1610-LF) because the boxes are labeled incorrectly. The box labeled for one product holds the other, so the product inside may not match the label. The recall covers 52 units and was distributed nationwide in the US and to the UK and France. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Freudenberg Medical2 products

The 36-month shelf life on COAPTIUM Connect peripheral nerve repair devices is not substantiated by real-time data, so devices will be relabeled with a 26-month shelf life. Using a device past its validated shelf life may cause it to break during surgery and become unusable; the worst-case outcome would be revision surgery. No injuries have been reported.

Moderate·FDA·Aug 12, 2026·Tissium7 products