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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.

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

The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.

Moderate

FDA

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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)

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)

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)

FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ0... – the items may have weak packaging sea... (2025)

Alinity ci-series System Control Module (SCM), REF: 03R70... (Abbott Laboratories) – abbott laboratories is recalling thei... (2025)

SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYN... – the items may have weak packaging sea... (2025)

InPen App, Model/CFN Number: MMT-8061 (Android Users) (Medtronic MiniMed, Inc.) – when app is uninstalled and reinstall... (2025)

KWIK-STIK, Quality control kit for culture media, Vibrio ... (Microbiologics Inc) – some products packaged for lot 818-11... (2025)

The Stryker CranialMask Tracker is a single-use device co... (Howmedica Osteonics Corp.) – when the device is activated during s... (2025)

1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCEL... (Remel, Inc) – products may contain contamination, w... (2025)

ChemoPlus gowns: Product Code Product Description CT5500T... (Cardinal Health 200, LLC) – mislabeling (2025)

Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. (AVID Medical, Inc.) – devices are not suitable for organ tr... (2025)