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Brand name: AGFA Digital Radiography X- Ray system DR 800... (AGFA Healthcare Corp.) – it is possible to exceed the maximum ... (2025)

It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.

Moderate

FDANov 18, 2025Nationwide• AGFA Healthcare Corp.

Ondansetron ODT Tablets (Preferred) – Defective Packaging (2025)

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.

Class IIModerate

FDANov 17, 2025IN• Preferred Pharmaceuticals, Inc.

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Brand name: AGFA Digital Radiography X- Ray system DR 800... (AGFA Healthcare Corp.) – it is possible to exceed the maximum ... (2025)

Ondansetron ODT Tablets (Preferred) – Defective Packaging (2025)

Orthofix NorthStar OCT Navigation Surgical Technique Guid... (SEASPINE ORTHOPEDICS CORPORATION) – the northstar oct navigation surgical... (2025)

The Pressio 2 ICP Monitoring System, Model Number PSO-400... (Sophysa Rue Sophie Germain Besancon France) – customer complaints of pressio monito... (2025)

Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tape... (Sheathing Technologies Inc) – vaginal/rectal ultrasound probe cover... (2025)

Charlevoix Mild Cheddar Cheese (Boss Dairy Farms) – Listeria risk (2025)

Lava Bun Salted Egg Yolk (Prime Food Processing) – undeclared milk (2025)

Lava Bun Green Tea (Prime Food Processing) – undeclared milk (2025)

Cinacalcet Tablets 60mg (Cipla) – Nitrosamine Impurity (2025)

Cinacalcet Tablets 90mg (Cipla) – Nitrosamine Impurity (2025)

Halyard, EP LAB PK. Catalog Number: ESJH009-03. (AVID Medical, Inc.) – potential for incomplete seal on head... (2025)

Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST01... (AVID Medical, Inc.) – potential for incomplete seal on head... (2025)

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. S... (Fresenius Kabi USA, LLC) – software version 5 (2025)

GE Healthcare Carestation anesthesia system, product numb... (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.) – potential unexpected shutdown of care... (2025)

Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09. (AVID Medical, Inc.) – potential for incomplete seal on head... (2025)

Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUH... (AVID Medical, Inc.) – potential for incomplete seal on head... (2025)

Halyard, MAJOR PACK. Catalog Number: JEMJ10-01. (AVID Medical, Inc.) – potential for incomplete seal on head... (2025)

Cinacalcet Tablets 30mg (Cipla) – Nitrosamine Impurity (2025)

Vampire Slayer Garlic Cheddar (Face Rock Creamery) – Listeria risk (2025)

Ganirelix Acetate Injection (Lupin) – Impurity Specification (2025)