Summary Company Announcement Date: August 01, 2023 FDA Publish Date: August 04, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product Safety/Potential Foreign Material Company Name: Drägerwerk AG & Co. KGaA Brand Name: Brand Name(s) Product Description: Product Description Carina Sub-Acute Care Ventilators Company Announcement Drägerwerk AG & Co. KGaA initiated a…
Ozona Organics Issues Voluntary Recall of Select Liquid Probiotic Products Due to Possible Health Risk
Summary Company Announcement Date: August 01, 2023 FDA Publish Date: August 01, 2023 Product Type: Animal & VeterinaryFood & Beverages Reason for Announcement: Recall Reason Description Potential Foodborne Illness Company Name: Ozona Organics, LLC Brand Name: Brand Name(s) Ozona, Go Healthy Product Description: Product Description Liquid Probiotics for adults and toddlers; Probiotics for cats, dogs,…
Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results at the 12-month Stability Time Point
Summary Company Announcement Date: July 29, 2023 FDA Publish Date: July 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Out of Specification Results Company Name: Lupin Pharmaceuticals, Inc. Brand Name: Brand Name(s) Lupin Pharmaceuticals, Inc. Product Description: Product Description Tydemy oral contraceptive Company Announcement Baltimore, Maryland, July 28, 2023: Lupin Pharmaceuticals Inc….
Frito-Lay Issues Allergy Alert on Undeclared Soy and Wheat in Doritos Nacho Cheese Flavored Tortilla Chips Distributed in Pennsylvania
Summary Company Announcement Date: August 01, 2023 FDA Publish Date: August 01, 2023 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared Soy and Wheat Allergen Company Name: Frito-Lay Brand Name: Brand Name(s) Product Description: Product Description Doritos Nacho Cheese Tortilla Chips Company Announcement PLANO, Texas – August…
Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with Dose IQ Safety Software for Repeat Upstream Occlusion False Alarms
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) Product Codes: 35700BAX2…
Baxter Issues Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ Infusion Pumps with Specific Software Versions
Summary Company Announcement Date: July 28, 2023 FDA Publish Date: July 31, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to an increase in reported false upstream occlusion alarms following the software upgrades. Company Name: Baxter International Inc. Brand Name: Brand Name(s) SIGMA Spectrum and Spectrum IQ Product Description: Product Description…
GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: TruSignal Adult Pediatric Sensor TruSignal AllFit Sensor TruSignal Sensitive Skin Sensor TruSignal Wrap Sensor TruSignal Ear Sensor TruSignal Integrated Ear Sensor with GE Connector TruSignal…
Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a voluntary correction, not a product removal. Recalled Product Product Names and Product Codes: Impella 5.0 Blood Pump, Product Number 005062 Impella CP…
Abbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Amplatzer Steerable Delivery Sheath Product Model: ASDS-14F-075 Distribution Dates: October 4, 2022 to February 22, 2023 Devices Recalled in the U.S.: 672 Date Initiated by…
Contact Lenses: Safe Use of Hydrogen Peroxide Solution
Image Español If you wear contact lenses, the way you clean and disinfect them can affect your vision and health. Following instructions from your eye care professional and from the contact lens solution manufacturer are especially important if you use a solution that contains hydrogen peroxide. Hydrogen Peroxide Solution Contact lens solutions are sold over…