MedWatch Safety Alerts

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination

Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the

Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or Under-Delivery of Therapy

Tubing occlusion or a false “No Disposable Attached” alarm may cause the CADD system to delay, interrupt, or under-deliver therapy

2023 Medical Device Recalls

2023 Medical Device Recalls

IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency

IBSA Pharma Inc. is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution to the consumer level. This voluntary recall has been initiated because

Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices

Certain Philips Respironics masks for BiPAP and CPAP machines are recalled due to a risk that their magnetic clips may interact with other medical devices

Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: Letter to Health Care Providers

Certain Philips masks can cause potential injury or death if magnets interfere with certain implanted metallic medical devices or metallic objects in the body

Medtronic Recalls Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters for Potential Catheter Hub Defect

A catheter hub defect may cause the Mahurkar Acute Dual Lumen High Flow Catheter to leak across the catheter’s two tubes

Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene – UPDATED

Edgewell Personal Care Company (NYSE: EPC) today expanded its voluntary nationwide recall of three batches of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 to the consumer

LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure

The LifeSPARC System is being recalled because users can inadvertently cause extended pump stop. A software update will address this issue

LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure

The LifeSPARC System is being recalled for risk that users can inadvertently cause extended pump stop when replacing the controller after software malfunction

Emergent Recalls Certain RSDL (Reactive Skin Decontamination Lotion) Kits Due to Leak Potential

RSDL Kits may leak, reducing the effectiveness of the kit when it is needed or exposing users unnecessarily to the decontamination lotion

Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump Through Damaged Balloon Catheter, Causing Patient Harm

Blood may enter the Cardiosave IABP through a damaged balloon catheter, causing pump shut-down, or patient exposure to helium or cross-contaminated blood

Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Due to Faster Than Expected Flow Rates That May Impact Infusion Delivery

The Intera 3000 Hepatic Artery Infusion Pump is being recalled after reports that it has a faster than expected flow rate

Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product

Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to manufacture or

Smiths Medical Issues Urgent Medical Device Correction Letter Notifying Customers of Potential Issues with CADD™ Infusion System Infusion Sets for Use with CADD Pumps

Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two potential issues with CADDTM Infusion System Infusion Sets related to potential

2022 Safety Communications

Listing of Medical Device 2022 Safety Communications

ACTUALIZACIÓN: Se retiran del mercado ciertos ventiladores, máquinas BiPAP y máquinas CPAP de Philips Respironics debido a posibles riesgos para la salud: Comunicado de seguridad de la FDA

ACTUALIZACIÓN: Se retiran del mercado ciertos ventiladores, máquinas BiPAP y máquinas CPAP de Philips Respironics debido a posibles riesgos para la salud: Comunicado de seguridad

Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The Presence of Visible Glass Particulates

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride Injection, USP, 1.5 g/vial Single Dose Flip-top Vial, lot 33045BA, to the user level

GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to Microbial Contamination

Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn® Cream, 0.9 g single-use packets. The single use packets are

Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 Due to Product Mix-Up

Accord Healthcare, Inc. is voluntarily recalling a single lot of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons