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: iCast Covered Stent Product Lot Numbers: See recall database entry Distribution Dates: December 31, 2018, to March 31, 2022 Devices Recalled in the U.S.: 68,812…
Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers
June 2, 2022 The U.S. Food and Drug Administration (FDA) is informing laboratory personnel and health care providers about a cybersecurity vulnerability affecting software in the Illumina NextSeq 550Dx, the MiSeqDx, the NextSeq 500, NextSeq 550, MiSeq, iSeq, and MiniSeq, next generation sequencing instruments. These instruments are medical devices that may be specified either for…
Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without 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 Name: Philips Respironics V60 and V60 Plus Ventilator Product Codes and Serial Numbers See recall database entries: Distribution Dates: May 1, 2009 to December 22, 2021…
Baxter Issues Urgent Medical Device Correction to Reinforce Important Safety Information Regarding Possible Risk of Oxygen Desaturation While Using Volara Device in Line With Ventilator in a Home Care Environment
Summary Company Announcement Date: June 01, 2022 FDA Publish Date: June 02, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Possible risk of oxygen desaturation Company Name: Baxter International Inc. Brand Name: Brand Name(s) Product Description: Product Description Volara System (home care) Company Announcement Deerfield, Ill. – 2022-06-01 – Baxter International Inc….
UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication
Date Issued: June 2, 2022 The U.S. Food and Drug Administration (FDA) is updating our safety communication issued in March 2022 to inform consumers and health care providers about a new handpiece for the Apyx Renuvion/J-Plasma device system that can be used for certain aesthetic skin procedures. On May 25, 2022, the FDA cleared the…
ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of Smoke or Fire When Lift Is Used with Depleted Battery
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: ArjoHuntleigh Polska Sara Plus floor lift Product Serial Numbers: See recall database entry Manufactured Dates: October 13, 2016, to January 13, 2022; Other units that…
Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm
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: Dragonfly OpStar Imaging Catheter Product Lot Numbers: See recall database entry Devices Recalled in the U.S.: 4,800 Date Initiated by Firm: April 11, 2022 The…
Urgent Voluntary Recall: CorneaGen Cornea/ Cornea Patch Grafts; CorneaGen is voluntarily recalling Corneal Patch Grafts bearing the following product numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103
Firm:CorneaGen1200 6th AveSuite 300Seattle, WA 98101T: 206-701-5840 Product Numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103 On January 5, 2022, CorneaGen discovered that Cornea Patch Grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and were shipped prior to being medically cleared. Additional serology results found the donor to be non-reactive for HIV…
Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure
Summary Company Announcement Date: May 20, 2022 FDA Publish Date: May 23, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Dissolution Test Failure Company Name: Teva Pharmaceuticals USA Brand Name: Brand Name(s) Product Description: Product Description Anagrelide Capsules Company Announcement Parsippany, NJ. Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a…
Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338
Firm:CorneaGen1200 6th AveSuite 300Seattle, WA 98101T: 206-701-5840 Lot Number: W419221008338 Product Numbers: W419221008338005; W419221008338006; W419221008338007; W419221008338008; W419221008338009; W419221008338010; W419221008338011; W419221008338012; W419221008338013; W419221008338014; W419221008338015; W419221008338016; W419221008338017; W419221008338018; W419221008338019 On January 5, 2022, CorneaGen discovered that Scleral Patch Grafts (Lot Number WA419221008338) were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and HIV…