Medical device recalls

Securitas Healthcare identified a firmware problem in certain Arial 900 MHz Call Station units (Model CSK200-900MR, Firmware 1.6.3) sold between January 2023 and June 2024. The affected units may fail to send a low battery alert to the wireless system before the battery dies, or may not send the alert at least 7 days in advance as designed. This could leave the call station without power when someone needs to use it.

A firmware issue in certain Securitas Healthcare Arial 900 MHz call stations (Model CSK200-900) may prevent them from sending low battery warnings to the wireless system. This means the device could lose power without giving you advance notice. The affected units were sold between January 1, 2023 and June 26, 2024.

Abiomed has recalled 2 units of the Impella 5.5 with SmartAssist S2 heart pump device because the devices were shipped in incorrect outer box cartons. This packaging error may affect proper device identification and handling. No injuries have been reported.

Sophysa's Pressio 2 ICP Monitoring System (Model PSO-4000) may unexpectedly reboot during use. This device is used in hospitals to measure pressure inside the skull. The reboots could interrupt critical monitoring of patients.

A software issue in certain BD Pyxis ES Enterprise Server systems may prevent timely updates of patient, medication, and related information from reaching the dispensing cabinets. This could delay access to critical data in healthcare settings. BD and the FDA are working to address the problem.

Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.

Beckman Coulter UniCel Dxl 800 analyzers (part numbers 973100, A71456, A71457, A25288) may fail to restart after shutdown due to a communication issue. When this happens, the analyzer cannot initialize or process patient samples, QCs, or calibrators, which delays test results.

Certain Beckman Coulter UniCel DxL 600 analyzers may fail to restart properly after shutdown due to a communication issue. When this happens, the analyzer cannot process patient samples or quality control checks, which can delay test results.

Meridian Bioscience's Revogene C. difficile diagnostic test (a lab assay used with the Revogene instrument) may show declining accuracy over time in certain lots. This could produce false-negative results, meaning the test might not detect C. difficile infection when it is present.

Applied Medical Resources has recalled certain Kii Low Profile trocar units because the blade obturator may extend beyond its proper length after assembly. This defect could affect the device's safe function during use. No injuries have been reported.

Roche Diagnostics has recalled certain lots of the Elecsys Anti-TSHR blood test due to inconsistent results across different laboratory instruments and variations between calibrator batches. These issues could lead to incorrect or delayed thyroid diagnosis and treatment.

Philips Healthcare has recalled certain Incisive CT scanners due to an unstable internal connection in the floating sensor. This instability may cause the scanner to produce incomplete or compromised scans. The issue affects 35 devices distributed across the U.S. and its territories, and no injuries have been reported.

AVID Medical is recalling the Halyard MINI PLUS KIT SOUTH (Kit Code JACK097-08) because the devices are not suitable for organ transplant procedures. The recall affects 380 units distributed in Florida, Georgia, and Puerto Rico.

Halyard's ORGAN RECOVERY OR PACK (Kit Code LLOF1000-17) is not suitable for organ transplant procedures. The FDA has classified this as a Class I recall, the most serious type. A total of 52 units were distributed in Florida, Georgia, and Puerto Rico.

Halyard ORGAN RECOVERY OR PACK (Kit Code LLOG1000-15) devices have been found to be unsuitable for organ transplant use. The FDA has issued a Class I recall affecting 132 units distributed in Florida, Georgia, and Puerto Rico. No injuries have been reported.

Siemens LUMINOS Lotus Max and Luminos dRF Max X-ray systems with software version VF11 may show incorrect collimation (beam positioning) when quickly switching between organ programs. This affects only systems with a bucky wall stand for mobile detectors and no ceiling stand.

Vision RT identified that instructions for the AlignRT InBore radiation therapy system omitted required information about its six Class 1 lasers and their specifications. The missing details are required by federal laser safety regulations. No injuries have been reported.

Beaver-Visitec International's BVI Leos Laser and Endoscopy System (Model OME6000U) has a manufacturing defect in the USB cable that connects the Nurse Monitor touchscreen to the System Controller. The cable is missing required ferrite components that protect against electromagnetic interference. Five units with specific serial numbers were affected and distributed in Florida, Michigan, Oklahoma, Texas, and Wisconsin.

Philips EPIQ Ultrasound Systems with the X5-1c transducer and certain software versions may unexpectedly restart on their own. This automatic reboot can damage the transducer. No injuries have been reported.

Sheathes3D Seamless Viral Barrier ultrasound probe covers may have manufacturing defects that could allow contamination during medical use. This poses a risk of infection to patients. The recall affects a limited quantity distributed in Washington State.

Ferndale Laboratories is recalling Mastisol Liquid Adhesive (lot 24161B, expiration 10-31-2029) because the butyrate tube can crack when you try to use it, making the product unusable. This affects 24,589 vials distributed in the US and UK.

Some units of the Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe (catalog VS0135.25, lot 2509040) may not fit smoothly through a 25-gauge cannula as intended. This could affect proper use during medical procedures. The recall affects 221 units distributed in the US and Japan.

Atomstack material processing laser products lack a required remote interlock connector that is designed to shut down the laser if the protective enclosure is opened. This safety feature is mandated by federal laser safety regulations to prevent accidental exposure.

Beckman Coulter Bicarbonate Reagent (catalog numbers OSR6137, OSR6237, OSR6637) used in laboratory analyzers may produce falsely high bicarbonate test results. This happens because a substance in blood samples called Lactate Dehydrogenase (LDH) interferes with the test. Affected lot numbers are listed in specific ranges for each catalog number.

A software problem in the Medtronic Restore Clinician Programmer App (versions before v.1.0.4489) can cause a Device Reset message that cannot be cleared. In rare cases, this prevents the pain management device from resuming therapy, causing patients to experience pain symptoms again. The implanted devices themselves are not affected—only the programmer application used by clinicians.

Cook Medical recalled Rösch-Uchida Transjugular Liver Access Sets (part number RUPS-100) used in liver procedures because some units were manufactured incorrectly. Affected devices may have been cut to the wrong length, not properly trimmed, or not inspected. Only 23 units were affected worldwide.

Cook Medical found that certain Ring Transjugular Intrahepatic Access Sets used in liver procedures were manufactured incorrectly. Affected devices may have been cut to the wrong length, trimmed improperly, or not inspected properly before shipment. This involves 15 units distributed worldwide.

Cook Medical recalled certain Flexor Check-Flo Introducer and Set models because some units were manufactured out of specification. Affected devices may have been cut to incorrect lengths, not properly trimmed, or not inspected properly. This is a medical device used in vascular procedures.

Diasol has recalled a bicarbonate dialysis liquid concentrate (product 100425-10-DEX100, lot PHV08042) because the FDA cannot confirm it is safe and effective for use. The recall affects approximately 2,200 gallons distributed across Missouri, California, Arizona, Texas, Illinois, and Massachusetts.

Safety and efficacy of dialysis acid concentrate cannot be assured