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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.

Moderate·FDA·Dec 31, 2025

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.

Moderate·FDA·Dec 31, 2025

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.

Moderate·FDA·Dec 31, 2025·Agfa

A New Life Herbs is recalling nine herbal supplement products sold as alcohol tincture, capsule, and dropper-bottle products, including products for immune, pain, sinus, and baby-care use. The FDA says the labels make unapproved drug claims and the products lack a Supplement Facts label. The products were distributed in AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, and TN, and no injuries have been reported.

Moderate·FDA·Dec 31, 2025·A New Life Herbs9 products

Karabetian is recalling two frozen Zimi products: Zimi Puff Pastry French Style (700 g) and Zimi Kunefe ready-to-eat (380 g). The products were exported to the US and contain partially hydrogenated oils (PHOs), which the FDA does not consider safe in food. The products were distributed in AZ, CA, CO, FL, GA, ND, OR, TX, WA and WI, and no illnesses have been reported.

Moderate·FDA·Dec 31, 2025·Zimi2 products

Some packages of Ritz Peanut Butter Cracker Sandwiches (27.6 oz, 20-count boxes) were mislabeled and may contain peanuts that are not declared on the package. This poses a serious risk to people with peanut allergies. The affected product was distributed in Alabama, Georgia, New Jersey, Pennsylvania, New York, Oklahoma, Arkansas, and Missouri.

Moderate·FDA·Dec 31, 2025

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.

Moderate·FDA·Dec 31, 2025

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.

Moderate·FDA·Dec 31, 2025

Merck is recalling two prescription medicines, Emend (aprepitant) for oral suspension 125 mg single-dose kits and Noxafil Powdermix (posaconazole) 300 mg packets, because they may contain metal particles. The recall covers 3 Emend kits and 845 Noxafil Powdermix kits, distributed nationwide. No injuries have been reported.

Moderate·FDA·Dec 31, 2025·Merck2 products

Cepheid is recalling two Xpert BCR-ABL Ultra in vitro diagnostic test kits, 10,357 units in total. Specimens with a white blood cell count above 30,000 cells may produce inaccurate test results. No injuries have been reported.

Moderate·FDA·Dec 24, 20252 products

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.

Moderate·FDA·Dec 24, 2025

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.

Moderate·FDA·Dec 24, 2025·Smith & Nephew

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.

Moderate·FDA·Dec 24, 2025·Myofunctional Research

Rocket Medical's 12Fg Seldinger Catheter chest tubes have misleading instructions that may lead to improper securing of the device. This increases the risk that the catheter could fall out during use. The FDA has identified 240 units across multiple lot codes distributed in the US and internationally.

Moderate·FDA·Dec 24, 2025·Rocket Medical6 products

DSAART is recalling six AART silicone implant products, covering about 594 implants in total. The implants were made outside the company's specifications and were distributed without the FDA premarket approval or clearance required for them. No injuries have been reported.

Moderate·FDA·Dec 24, 2025·DSAART6 products

Copan is recalling two versions of its 1 ml DTT liquid-phase transfer tubes used to liquefy respiratory specimens, covering 245,700 units in total. The company cannot guarantee the treatment reagent will work properly, so specimen liquefaction may not be reliable. The tubes were distributed to 14 states, and no injuries have been reported.

Moderate·FDA·Dec 24, 2025·Copan2 products

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.

Moderate·FDA·Dec 24, 2025·DICOM Grid

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.

Moderate·FDA·Dec 24, 2025

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.

Moderate·FDA·Dec 24, 2025

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.

Moderate·FDA·Dec 24, 2025

AVID Medical is recalling five Halyard procedure packs because the header bag may not be fully sealed. The recall includes 728 units distributed in Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.

Moderate·FDA·Dec 24, 20255 products

Zimmer Biomet is recalling two surgical skin-graft tools, the Zimmer Air Dermatome and the Zimmer Dermatome AN, because the thickness control bar may be misaligned. The recall covers 1,337 units (839 Air Dermatomes and 498 AN Dermatomes) distributed across many countries, including the USA. No injuries have been reported.

Moderate·FDA·Dec 24, 20252 products

Medline is recalling 2 sterile surgical products, sold nationwide and distributed in CA, CO, IL, KS, and MI, because their packaging seals may be weak. If a seal fails, sterility may be lost, which could raise the risk of infection if the product is used. No injuries have been reported.

Moderate·FDA·Dec 24, 20252 products

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.

Moderate·FDA·Dec 24, 2025

Dough-To-Go Inc is recalling Linzer Hearts Baked Cut Out Cookies because the labels do not declare milk and FD&C Blue #1 (a food coloring) as ingredients, even though they are present in the product. This poses a serious risk to people with milk allergies or those sensitive to artificial dyes. The affected cookies were distributed in Tennessee.

Moderate·FDA·Dec 24, 2025

Celebration Herbals Senna Leaf Herbal Tea (24 teabags, 1.48 oz) may be contaminated with Salmonella. The affected product has lot code 251004 with a best-by date of October 29, 2028. No illnesses have been reported.

Moderate·FDA·Dec 24, 2025

BaiLiFeng Dried Cinnamon Powder (4 oz bags, UPC 4 897055 79940 1) contains unsafe levels of lead. The FDA has recalled 150 bags distributed in Massachusetts. No injuries have been reported.

Moderate·FDA·Dec 24, 2025

The New York Milk Bank is recalling 66 bottles (4 ounce/120 ml) of pasteurized donor human milk due to the presence of a foreign object in one batch. The affected bottles have green lids and foil seals, with batch number 14559-01 and expiration date 5/12/26. No injuries have been reported.

Moderate·FDA·Dec 24, 2025

Hollandia Dairy's 100% Appleberry Juice in half-pint bottles was contaminated with peracetic acid, a cleaning solution. The affected juice was distributed to schools in San Bernardino County and Camp Pendleton. No injuries have been reported.

Moderate·FDA·Dec 24, 2025·Hollandia Dairy

Chef brand 24cm milk pans were found to leach lead at levels of 3.00 mg/L, which exceeds safe limits. The affected cookware was distributed in New York, New Jersey, Connecticut, Massachusetts, Maryland, Virginia, and Pennsylvania. No injuries have been reported.

Moderate·FDA·Dec 24, 2025