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Intelerad InteleShare software, with ProViewer component (DICOM Grid, Inc.) – software intended to aid in diagnosin... (2025)

Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.

Moderate

FDANov 18, 2025AL, AK, AZ +42 more• DICOM Grid, Inc.

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

Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.

Moderate

FDANov 17, 2025Nationwide

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Intelerad InteleShare software, with ProViewer component (DICOM Grid, Inc.) – software intended to aid in diagnosin... (2025)

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

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

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

Halyard, MAJOR PACK. Catalog Number: JEMJ10-01. (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)

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)

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

Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09. (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)

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

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

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

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

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