Indiana recalls

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.

A New Life Herbs Sinus Cap herbal supplement is being recalled because the product makes unapproved claims about treating sinus issues and lacks required supplement facts labeling. The FDA determined the product is misbranded and does not meet federal requirements for herbal supplements.

A New Life Herbs' Pain Away herbal supplement contains labeling that makes drug claims (like "analgesic" and "anti-inflammatory") without FDA approval. The product also lacks a required Supplement Facts label, making it misbranded. About 275 bottles were distributed across 13 states.

A New Life Herbs is recalling its Organic Ginger Root Herbal Supplement because the product makes unapproved drug claims on its label and is missing required Supplement Facts labeling. The product was sold in 50-capsule plastic bags in multiple states.

A New Life Herbs is recalling its Mullein flower alcohol tincture ear drops because the product makes unapproved claims about treating pain and infection, and the bottle lacks required supplement labeling. The FDA found 22 bottles (lot T553MF, expiring 12/28) distributed across multiple states.

A New Life Herbs Chaga Mushroom herbal supplement is being recalled because the label makes unapproved health claims (such as anti-cancer properties) and is missing required supplement information. The product does not meet FDA labeling standards for dietary supplements.

A New Life Herbs is recalling its Boswellia Herbal Supplement (2 oz. glass dropper bottle) because the product makes unapproved medical claims on its label and is missing required Supplement Facts labeling. The product was distributed in multiple states.

A New Life Herbs Baby Soothe herbal supplement is being recalled because it makes disease claims on the label without FDA approval and is missing required supplement facts information. The product was distributed in Alabama, Arizona, California, Georgia, Illinois, Indiana, Minnesota, Missouri, Mississippi, North Carolina, New York, and Tennessee.

A New Life Herbs is recalling its Baby Allergy Herbal Supplement because the product makes drug claims on the label that are not approved by the FDA, and it is missing required Supplement Facts labeling. The product contains echinacea, Oregon grape root, dandelion, burdock root, fenugreek, and ginger root in vegetable glycerin, sold in a 2 oz. glass dropper bottle.

A New Life Herbs is recalling its Anti-virus Herbal Supplement tincture because the product label makes drug claims that are not approved by the FDA and is missing required supplement nutrition information. The product was sold in 2 oz. glass dropper bottles in several states.

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.

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.

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.

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.

Instrumentation Laboratory recalled specific lots of HemosIL SynthAFax Partial Thromboplastin Time tests because they were manufactured with twice the intended amount of preservative. This could affect test accuracy. No injuries have been reported.

The instruction guide for SeaSpine's NorthStar OCT Navigation surgical instruments incorrectly states that the tools work with both Medtronic Solera and Infinity system toolcards. In fact, they only work with Solera toolcards. Using these instruments with an Infinity system toolcard could result in device malfunction during surgery.

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.