Devices

Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods

Early Alert: Thoracic Stent Graft Issue from Bolton Medical

Blood Glucose Monitor Recall: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems

Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication

Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices

Early Alert: Convenience Kit Issue from Aligned Medical Solutions

Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly

Insulet Corporation — Class I: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7

3B Medical, Inc. — Class II: React Health PHOENIX 5L Oxygen Concentrator

Remel, Inc — Class II: Yeastone Broth, 11ML, 10/BOX YY3462

ARJOHUNTLEIGH POLSKA Sp. z.o.o. — Class II: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US

Gentuity, LLC — Class II: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;

Integra LifeSciences Corp. (NeuroSciences) — Class II: Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.

Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Tandem Mobi Insulin Pumps

Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Namic Angiographic Rotating Adapter 10CC Control Syringe Placed into the Following Kits; AMS6908E Angio Pack, and AMS6908F Angio Pack

Early Alert: Convenience Kit Issue from American Contract Systems

Early Alert: Convenience Kit Issue from Medical Action Industries

Ventilator Tubing Correction: Percussionaire Corporation Updates Use Instructions for Phasitron In-Line Valve

Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants

Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators

Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer

Anesthesia Workstation Correction: Draeger Issues Correction for Atlan A350 and A350 XL

Early Alert: Convenience Kit Issue from AVID Medical

Ventilator Correction: Baxter Updates Use Instructions for Volara Single-Patient Use Circuits

ILET BIONIC PANCREAS (BETA BIONICS INC.) — Injury

INSET (UNOMEDICAL DEVICES S.A. DE C.V.) — Injury

GLIDEWELL HT IMPLANT Ø3.5 X 10 MM (PRISMATIK DENTALCRAFT, INC.) — Injury

ASSURITY MRI (ABBOTT MEDICAL (CRM-SYLMAR)) — Malfunction

QUICK SET (UNOMEDICAL DEVICES S.A. DE C.V.) — Injury

PUMP MMT-1884L MM780G BLE 3.0 MG/ML (MEDTRONIC PUERTO RICO OPERATIONS CO.) — Malfunction