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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.

Moderate·FDA·Dec 31, 2025

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

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

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

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

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

Taro Pharmaceuticals is recalling specific lots of Ciclopirox Shampoo 1% because the product failed quality tests for impurities and degradation at the 18-month mark. The affected lots expire January 31, 2026. No injuries have been reported.

Moderate·FDA·Dec 24, 2025

Preferred Pharmaceuticals is recalling ondansetron ODT 4mg tablets because the blister pack containers are not fully sealed, which can cause tablets to fall out. The manufacturer Glenmark Pharmaceuticals notified Preferred Pharmaceuticals of the sealing defect. This affects specific lot numbers distributed nationwide.

Moderate·FDA·Dec 24, 2025

Somerset Therapeutics is recalling three cisatracurium besylate injection products because testing found the drug may be weaker than its label states. The recall covers 10 mg/5 mL, 200 mg/20 mL and 20 mg/10 mL vials, all made by Somerset Therapeutics in India and distributed nationwide. No injuries have been reported.

Moderate·FDA·Dec 24, 2025·Somerset Therapeutics3 products

Golden State Medical Supply's baclofen 10 mg tablets in 1,000-count bottles (Lot GS065762) may contain foreign tablets or capsules mixed in. This affects 2,472 bottles distributed nationwide. No injuries have been reported.

Moderate·FDA·Dec 24, 2025

Novocol is recalling 7 dental anesthetic products because some cartridges may be cracked or broken. The products are sold under names including Xylocaine Dental, Polocaine Dental, Carbocaine, and OraVerse, plus private-label versions from Dentsply, Patterson Dental, darby dental supply, Benco Dental, and Cook-Waite. No injuries have been reported.

Moderate·FDA·Dec 24, 2025·Novocol7 products

Stryker is recalling 2 products: certain MV3 bariatric beds and Arise 1000EX mattresses. The products were sold close together, suggesting they may be used together, but they have not been tested for compatibility and are not designed to be used as a combination.

Moderate·FDA·Dec 17, 20252 products

Datascope is recalling two Cardiosave intra-aortic balloon pump systems, the Cardiosave Hybrid and the Cardiosave Rescue. The recall is for an addendum to the instructions for use that revises the preventative maintenance schedule to match the service manual update made in June 2023. No injuries have been reported.

Moderate·FDA·Dec 17, 20252 products

A screw in certain Nipro Surdial DX hemodialysis systems may loosen or fall out during use. This is a medical device used in dialysis treatment. The affected units have specific serial numbers issued between 2020 and 2024.

Moderate·FDA·Dec 17, 2025

Medline Industries is recalling DEXLOCK Achilles Repair Implant Kits (model MAKT4520, lot 19019) because the drill bit can fuse to the drill guide during surgery. This can delay the procedure while a replacement drill bit and guide are retrieved. No patient injuries have been reported.

Moderate·FDA·Dec 17, 2025

Bard is recalling four InLay Optima ureteral stent kits because the actual stent size may not match the size printed on the label. About 4,700 units are affected, and the kits were distributed in the US and several other countries. No injuries have been reported.

Moderate·FDA·Dec 17, 20254 products