Nebraska recalls

A faulty motor connector in certain da Vinci 5 surgical systems may cause Error 23062, which locks the surgeon console's ergonomic adjustments (viewer, headrest, armrest, and pedal position). This could delay or disrupt a scheduled surgical procedure. The issue affects 144 systems across 30 states.

The Stryker CranialMask Tracker, a surgical tracking device used during head and neck procedures, can display a software error message when activated in the operating room, making it unusable. This affects 320 units worldwide across specific lot numbers. No injuries have been reported.

BD Pyxis automated medication dispensing cabinets used in hospitals and pharmacies received a firmware update that caused certain drawers to fail. When a drawer fails, staff may have difficulty accessing or restocking medications, which could delay patient care.

Alcon Custom Pak sterile surgical procedure packs used in eye surgery may have incomplete seals that could compromise sterility. This affects 151 units across specific lot numbers. No injuries have been reported.

Draeger, Inc. is recalling certain Vapor 3000 anesthetic vaporizers (Model M36500) because a component inside was not built to specification and contains impurities. This affects 188 units with specific serial numbers distributed worldwide. No injuries have been reported.

Draeger, Inc. is recalling certain Vapor 2000 anesthetic vaporizers because an internal component was manufactured with impurities and did not meet quality specifications. The affected units are identified by specific serial numbers and were distributed worldwide, including across the United States.

AGFA's DR 800 digital X-ray system can deliver higher radiation doses than the FDA allows during certain fluoroscopy procedures. This happens when the frame rate is increased on the NX workstation without proper safety features enabled. About 35 systems are affected nationwide.

Choceur Cookie Butter Holiday Bark sold at Aldi contains pecan that is not listed on the label. People with pecan allergies could have a serious reaction if they eat this product. The recall affects specific lot numbers with best-by dates through June 2026.

Choceur Pecan Cranberry & Cinnamon Holiday Bark contains wheat that is not listed on the label. People with wheat allergies or celiac disease could have a serious reaction if they eat this product. The affected bags were sold at Aldi stores nationwide.

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.

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.

AVID Medical is recalling Halyard HEAD AND NECK TRAY (Catalog Number EURO016-09) due to a potential incomplete seal on the header bag. This affects 56 units distributed in Georgia, Illinois, Nebraska, and Maryland. An incomplete seal could compromise the sterility or integrity of the surgical tray.

AVID Medical is recalling Halyard Major Pack surgical kits (Catalog Number JEMJ10-01) because the header bag seal may not close completely. This affects 90 units distributed to Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.

AVID Medical is recalling Halyard arteriogram kits (Catalog Number EUHM009-01) because the header bag may not seal completely. This could allow the sterile contents inside to become contaminated. The recall affects 300 units distributed to hospitals in Georgia, Illinois, Nebraska, and Maryland.