Medical device recalls

Altruan GmbH distributed Clearest Strep-A Cassette Test kits that were not cleared or approved by the FDA before being sold. These tests are designed to detect group A streptococci (Strep A) in throat swab samples. About 188 units were distributed nationwide.

Wondfo Streptococcal A At-Home Self-Test kits were distributed in the US without FDA clearance. This means the test's accuracy and safety have not been verified by the FDA. If you have this test, results may not be reliable.

The Lutronic CLARITY II Laser System (Model 1110200210) may spark or pop during use, potentially causing burns to patients. The FDA has identified over 1,500 affected units based on serial number.

The Covidien HealthCast Vital Sync remote patient monitoring system has a defect that can prevent critical patient alarms from being transmitted from bedside monitors to remote monitoring stations. This means clinicians may not receive timely alerts about patient condition changes. The FDA has identified 78 affected systems.

International Life Sciences is recalling Artelon FLEXBAND TWIST surgical augmentation devices (lot RK29976) because they failed bacterial endotoxin testing. Bacterial endotoxins are substances that can trigger harmful immune responses if present on medical devices used in surgery.

International Life Sciences is recalling Artelon FlexBand Plus augmentation devices (Ref: 41054 and 41057) because they failed bacterial endotoxin testing. These devices may contain harmful bacterial contamination that could cause infection or other complications if implanted.

International Life Sciences is recalling Artelon FlexBand Dynamic Matrix augmentation devices (Ref: 31057) because they failed bacterial endotoxin testing. Bacterial endotoxins are substances that can trigger harmful immune responses. The devices were distributed worldwide, including throughout the United States and multiple international markets.

Beckman Coulter AU5800 chemistry analyzers with certain software configurations may experience errors that prevent the system from opening calibration databases after running for more than 15 minutes. When this happens, the analyzer stops working and requires a service technician to fix it, which can delay patient test results and treatment.

Certain Beckman Coulter DxC 700 AU clinical chemistry analyzers with specific software may stop working properly if left running for more than 15 minutes. The system will display database errors and stop analyzing patient samples. A technician from Beckman Coulter must visit your facility to install a software fix.

Boston Scientific is recalling certain EndoVive Safety PEG Kits that contain ChloraPrep Triple Swabsticks with open or damaged packaging. The affected swabsticks may have lost sterility or dried out. The rest of the kit components remain safe and unaffected.

Medartis discovered that certain packages labeled as 2.8mm APTUS TriLock Screws may actually contain 2.5mm screws instead. This size mix-up could affect surgical fixation in hand, forearm, shoulder, or foot procedures. The issue affects 126 units distributed in the US (Indiana and Pennsylvania) and 12 European and other countries.

Medartis AG recalled specific lots of APTUS 2.5 TriLock Screws used in hand, forearm, shoulder, and foot surgery because some packages may contain 2.8mm screws instead of the labeled 2.5mm size. Using the wrong size screw could affect surgical fixation.

The instruction manuals for TRUE METRIX GO blood glucose meters sold at Walgreens, CVS, Meijer, and other retailers do not clearly explain what an E-5 error code means or what you should do about it. An E-5 error can indicate a dangerously high blood glucose level, and the instructions should tell you to contact a healthcare professional right away.

The instruction manuals for TRUE METRIX AIR blood glucose meters sold at Walgreens, CVS, Walmart, and other retailers don't clearly explain what the E-5 error code means or what to do about it. An E-5 error can signal a dangerously high blood glucose level, but the current instructions don't emphasize this or tell you to contact a doctor right away.

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

Physio-Control infant and child defibrillator electrodes may separate or peel apart during use, which could prevent proper delivery of therapy. The affected electrodes are pre-gelled, self-adhesive pads designed for use with automated external defibrillators (AEDs) on children under 8 years old or weighing less than 55 pounds. No injuries have been reported.

Certain GEM PAK cartridges for the GEM Premier 5000 blood gas analyzer may fail quality control checks during startup, causing the cartridge to eject and need replacement. This can delay test results and require you to insert a new cartridge. The issue affects specific lot numbers distributed worldwide.

Instrumentation Laboratory GEM PAK cartridges (part number 00055445008) for the GEM Premier 5000 blood gas analyzer may eject repeatedly during warm-up due to detection errors. This can delay test results and require operator intervention to restart testing. The issue affects 70 units distributed worldwide.

Some GEM PAK cartridges used in Instrumentation Laboratory's GEM Premier 5000 blood analyzer are experiencing repeated detection errors during startup, causing cartridges to eject unexpectedly. This can delay test results and require operators to insert replacement cartridges. The issue affects 130 units distributed worldwide.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer are experiencing repeated "Process Control Solution Not Detected" errors during startup, causing the cartridges to be ejected and requiring replacement. This can delay test results. The affected cartridges are lot numbers 251114K, 251205K, and 251215D (Part No. 00055430011).

Certain GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood analyzer may eject repeatedly during startup due to detection errors. This can cause delays in test results and require staff to replace cartridges multiple times. The issue affects specific lot numbers manufactured between October and December 2025.

Some GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood analyzer are experiencing increased errors during startup that cause the cartridge to eject prematurely. This may require staff to insert a new cartridge and repeat the startup process, which can delay test results. The device's built-in quality monitoring system (iQM2) continues to verify results, so cartridges that pass validation can remain in use.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer are experiencing repeated error messages during startup that cause the cartridge to eject. This may delay test results and require inserting replacement cartridges. The affected cartridges are from specific lot numbers manufactured in late 2025.

Instrumentation Laboratory has identified that GEM PAK cartridges for the GEM Premier 5000 blood gas analyzer may fail quality checks during startup, causing the cartridge to eject. This can happen multiple times in a row, which delays test results. The cartridges that pass quality checks after startup can continue to be used.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer are experiencing increased errors during warm-up that cause them to eject unexpectedly. This can require repeated cartridge replacements and may delay test results. Most cartridges continue to work normally, but consecutive ejections could disrupt lab operations.

Some GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood gas analyzer may reject during the warm-up process, requiring replacement cartridges to be inserted. This can delay test results and may require doctors to reassess patient care once results are available. The issue affects specific lot numbers distributed worldwide.

Some GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood gas analyzer are ejecting repeatedly during warm-up due to detection errors. This can delay test results and require staff to insert new cartridges multiple times. The device's quality control system (iQM2) will catch problems, but consecutive ejections may slow lab operations.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer may fail to detect process control solution during warm-up, causing the cartridge to eject unexpectedly. This can delay test results and require staff to insert a new cartridge. Most cartridges continue to work normally, but consecutive failures may disrupt lab operations.

Instrumentation Laboratory has identified that some GEM PAK cartridges (part no. 00055407511) for the GEM Premier 5000 blood analyzer may fail quality checks more frequently during startup, causing the cartridge to be ejected. This can delay test results and may require multiple cartridge replacements. The GEM Premier 5000's built-in quality monitoring system (iQM2) will catch and reject any cartridges that do not pass validation, so cartridges that complete the validation process remain safe to use.