Wisconsin recalls

Zimi Kunefe frozen kunefe (a Middle Eastern pastry) contains partially hydrogenated oils, which are banned in foods sold in the US. The FDA detected this prohibited ingredient in specific lots distributed across multiple states.

Zimi Puff Pastry French Style (frozen, 700 g packages) contains partially hydrogenated oils (PHOs), which are banned in U.S. food products. The affected frozen pastry was distributed to 10 states. No injuries have been reported.

Bell Industries LLC is recalling Zen Cleanse Blend herbal tea pouches (Lot A8205, expiration 11/2028) due to potential Salmonella contamination. The affected product was distributed to three customers in Massachusetts, Texas, and Wisconsin and did not reach retail shelves. No illnesses have been reported.

Grandma Belle's Tomato Basil Soup (17 oz glass jars) may contain milk that is not listed on the label. The product was distributed across 14 states. No illnesses have been reported, but people with milk allergies or sensitivity could have a serious reaction if they consume it.

Merck has recalled specific lots of Noxafil Powdermix, a prescription antifungal medication, because some packets may contain metal particles. This affects 845 kits distributed nationwide. No injuries have been reported.

Merck has recalled a limited lot of Emend (aprepitant) 125 mg oral suspension due to the potential presence of metal particles in the product. This affects 3 single-dose kits with lot number Z014503 and expiration date 11/15/2027 distributed nationwide.

Abbott Laboratories is recalling certain Alinity ci-series System Control Modules with software version 3.6.1 or lower due to a performance issue that could produce inaccurate lab test results. The issue affects multiple analytes and was discovered during Abbott's internal testing.

Cepheid's Xpert BCR-ABL Ultra diagnostic test kits may produce inaccurate results when testing blood samples with very high white blood cell counts (above 30,000 cells). This affects certain lot numbers distributed across the US and internationally. No injuries have been reported.

Cepheid's Xpert BCR-ABL Ultra diagnostic test kits may give inaccurate results when testing blood samples with very high white blood cell counts (over 30,000 cells). This affects specific lot numbers distributed across the US and internationally. No injuries have been reported.

Medtronic MiniMed InPen App users on Android (versions 7.5.0, 7.5.1, and 8.0.0) may lose insulin reminders if they uninstall and reinstall the app. The notification settings screen doesn't appear during setup, preventing notifications from overriding your phone's mute or Do Not Disturb mode. This could delay insulin therapy.

Smith & Nephew is recalling certain BIOSURE HA Screws (6mm x 20mm bone fixation screws) due to a labeling error on affected units. The screws themselves are safe, but the packaging labels on a small number of units contain incorrect information. No injuries have been reported.

Myofunctional Research Company USA distributed Myosa for Kids mouthguards in the U.S. without FDA approval. The company mistakenly sold approximately 436 units of these devices, which are designed for children ages 3–15 to help with breathing and myofunctional disorders. No injuries have been reported.

DSAART LLC distributed calf implants that did not meet FDA requirements. The products were sold without required FDA premarket approval or clearance, and some deviated from manufacturing specifications. Approximately 35 implants were distributed across multiple U.S. states.

DSAART LLC distributed AART Pectoral Implants that were manufactured differently than approved and were sold without required FDA clearance. The implants do not meet established safety and quality standards. Affected models were distributed across multiple U.S. states.

DSAART LLC distributed AART Malar Implants (model 401-202-5 and 401-202-6, lot numbers 24-01-014 and 24-01-015) without obtaining required FDA premarket approval and with deviations from established manufacturing specifications. Two implants were affected and distributed across multiple U.S. states.

DSAART LLC distributed AART Chin Implants that were manufactured with deviations from established specifications and without obtaining required FDA premarket approvals or clearances. The affected implants were distributed across multiple U.S. states.

DSAART LLC distributed gluteal implants without FDA approval and in ways that deviated from approved specifications. The FDA has recalled 118 implants across multiple models and lot numbers distributed in 28 U.S. states and territories. No injuries have been reported.

DSAART LLC distributed AART Silicone Carving Implants without obtaining required FDA premarket approval or clearance, and some products deviated from established manufacturing specifications. These implants are used in augmentation and reconstructive surgery. The FDA has issued a Class II recall affecting 369 implants distributed across multiple U.S. states.

Intelerad InteleShare medical imaging software versions 3.24.3 through 3.25.2 contain a bug that can produce inaccurate measurement values when certain viewing features are used together. This could lead to incorrect measurements on medical images, potentially affecting diagnosis and treatment planning.

A speaker component change in certain PATH Madsen Accuscreen DPOAE probes can cause technical distortions that mimic real hearing responses. This may result in incorrect "PASS" outcomes on infant hearing screening tests when a baby should have failed. The issue occurs when high stimulus levels combine with the device's sensitivity settings.

GE HealthCare ViewPoint 6 versions 6.15.3 and 6.15.4 may not display complete patient medical history information in the Patient History tab. This affects specific ultrasound systems used in medical facilities. No injuries have been reported.

Datascope Corp. has issued an updated instruction manual (IFU) for the Cardiosave Rescue defibrillator. The update corrects references in the Vibration and Shock Table to match the proper technical standards. This affects 47 units distributed in the US and internationally.

Datascope Corp. is updating the instruction manual for Cardiosave Hybrid devices to correct references in the Vibration and Shock Table to ensure alignment with applicable standards. This is a documentation correction that affects multiple device models.

Zimmer Surgical Inc. is recalling certain Dermatome AN surgical devices (Model 88710100) because the thickness control bar may be misaligned. This could affect the device's ability to cut skin grafts to the correct thickness during surgery. No injuries have been reported.

Zimmer Surgical Inc. is recalling certain Zimmer Air Dermatome surgical devices because the thickness control bar may be misaligned. This could affect how the device operates during skin grafting procedures. No injuries have been reported so far.

Medline Industries' sterile Kelly forceps (5.5 inch, Item DYNJ04048) may have packaging seals that don't hold properly. If the seal fails, the sterile barrier is broken, which could allow bacteria or other germs to contaminate the instrument and increase infection risk if used.

Medline Industries sterile surgical scissors (5.5", Item DYND04000, Lot 2023102590) may have weak packaging seals that could break during storage or handling. If the sterile packaging fails, the scissors could become contaminated and increase infection risk if used in surgery or medical procedures.

Mindray's BeneVision Distributed Monitoring System (DMS) workstations with specific hardware and audio driver configurations may experience audio playback failure or screen freezing during operation. This can affect the usability of the central monitoring system in clinical settings. About 906 units are affected worldwide.

GE Healthcare has recalled certain Power Management Boards in Carestation 600 and 700 Series anesthesia systems. If AC power is lost or unplugged, these systems may unexpectedly shut down instead of switching to battery backup, causing temporary disruption of ventilation and medication delivery. After restart, the system will not return to its previous settings.

GE Healthcare has recalled certain Carestation 750 anesthesia systems that may unexpectedly shut down if AC power is lost or unplugged. When this happens, the system will not automatically switch to battery backup and will reboot, which can temporarily disrupt ventilation and medication delivery. After rebooting, the system does not return to its previous settings.