Wisconsin recalls

Goregent-branded infant walkers sold on Amazon can fit through standard doorways and do not stop at the edge of stairs, creating a serious fall risk. About 90 walkers with model number 901 and a yellow production label dated November 2025 are affected. No injuries have been reported yet.

BUILT brand LUUM light up tumblers can crack or break, exposing the button cell battery inside. Children can access and swallow these small batteries, which can cause serious internal burns, chemical injuries, or death. One child has already put a battery from one of these tumblers in their mouth.

Specialized electric bicycles in the Como SL line have forks that can develop small cracks over time, which may lead to fork failure and cause the rider to fall. The company has received one report of a fork failure but no injuries so far.

Tainoki Fine Furniture is recalling height-adjustable swivel office chairs sold at HomeGoods because the metal base can bend during use, creating a fall risk. The recall affects Noah, Owen, and Warren model chairs sold between August and December 2025. No injuries have been reported.

Wagner power steamers can develop an excessively hot hose and may expel hot water during or after use, even after you release the trigger. The company has received over 50 reports of burn injuries, including first- and second-degree burns to arms, hands, feet, and faces.

Medline surgical drapes and gowns may fall apart (delaminate) when washed using the included instructions. If a delaminated drape is used during surgery, it could tear and allow bacteria through, increasing infection risk.

Medline surgical gowns may develop fabric separation (delamination) when laundered using the included instructions. If a separated gown is used during surgery, fluid or bacteria could pass through the compromised fabric, potentially increasing infection risk.

Medline and Cardinal Health have recalled specific lots of chest drainage kits used in cardiac surgery because the instructions needed to clarify that these devices are intended only for adult patients age 18 and older. The kits were distributed nationwide in California and internationally to Chile and Panama.

Altruan GmbH distributed Bisaf Strep A Self-Test kits without FDA clearance. This test is designed to detect group A streptococcal antigens in throat swabs, but has not been reviewed or approved by the FDA for safety and effectiveness. About 188 units were distributed nationwide.

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).