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2024 Medical Device Recalls

Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector

paraPAC Plus P300 and P310 are emergency and transport portable ventilators. The patient outlet connector may be loose or detached, impacting ventilation.

Related Recalls - Plastic Syringes Made in China for Potential Device Failures

Related Recalls - Plastic Syringes Made In China for Potential Device Failures

Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination

September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be con

Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes due to Manufacturing Defect that May Cause Tracheostomy Displacement or Decannulation

Bivona tracheostomy tubes provide a secure airway in pediatric and adult patients. A manufacturing defect may lead to a tear in the tube’s flange.

2024 Safety Communications

Listing of Medical Device 2024 Safety Communications

Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in addition to Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, Due to Faulty Occlusion Alarm

Infusomat Space Infusion Systems deliver fluids, blood, and blood products. The occlusion alarm may sound when there is no occlusion, leading to delayed therapy.

Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture - FDA Safety Communication

Read the FDA’s recommendations related to the Zimmer Biomet CPT Hip System and increased risk of thigh bone fracture.

Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets

Ivenix LVP infusion pump precisely controls the flow of fluids to a patient. A defect in pump administration sets may cause uncontrolled flow.

FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. Stop Medicine if Signs and Symptoms of Liver Injury Occur - Drug Safety Communication

The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury.

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

Laryngoscope Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes, Updates Use Instructions for Others due to Increased Risk for Battery Overheat and Explosion

McGrath MAC Video Laryngoscopes help visualize the trachea and larynx. The batteries on these devices may deplete too much, causing overheating and explosion.

Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly Manufactured Ventilators

Vivo 45 LS ventilators support breathing in homes and health settings. New devices may expose users to elevated formaldehyde levels for a short time.

Continuous Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc Issues Recall for Certain FreeStyle Libre 3 Sensors due to Risk for Inaccurate High Glucose Readings

FreeStyle Libre 3 sensor provides continuous monitoring of glucose levels but a small number of sensors may give inaccurate high readings

Lung Therapy Component Recall: Baxter Healthcare Corporation Recalls Certain Volara System Single-Patient Use Circuits and Blue Ventilator Adapter Assemblies Due to Disconnection Risk That May Prevent Proper Ventilation

The Volara System provides lung therapy for patients on ventilators but some single-patient use circuits and blue ventilator adapter assemblies may disconnect.

Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue with Certain Bivona® Tracheostomy Tubes

Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona® Tracheostomy Tubes

Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion

Tandem Diabetes Care, Inc. recalls t:connect mobile app (v2.7) for t:slim X2 insulin pump due to software issue that may cause app to crash and deplete pump battery

2023 Safety Communications

Listing of Medical Device 2023 Safety Communications

Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication

A voluntary recall initiated by SoClean for use of SoClean2 and SoClean3 equipment to clean, sanitize or disinfect CPAP devices and accessories.

Convenience Kit Component Recall: Medline Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May Be Contaminated, Break, Leak, or Otherwise Fail

Syringes included in Medline Convenience Kits should not be used due to risk for contamination, breakage, or leakage.