UPDATE: On May 19, 2022, the FDA updated this safety communication to provide the latest information about medical device reports (MDRs) associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls. In addition, the FDA has taken additional actions since this updated safety…

January 11, 2022 Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338 Lot Number: W419221008338 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…

UPDATE: On May 19, 2022, the FDA updated this web page to help ensure patients and providers have important information about the recall of these critical devices. See What the FDA is Doing for more information. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines,…

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: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Distribution Dates: January 6, 2022, to January 20, 2022…

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: Avanos Medical Cortrak*2 Enteral Access System Product Codes and Serial Numbers: See recall database entry Distribution Dates: April 1, 2016 to January 1, 2022 Devices…

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. The devices described in this recall notice are the same devices announced in the FDA safety communication, Do Not Use Skippack Medical Lab SARS-CoV-2 COVID-19 Tests. Recalled Product Product…

Date Issued: May 10, 2022 The U.S. Food and Drug Administration (FDA) is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of…

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: Accula SARS-CoV-2 Test Product Codes: QJR Lot Numbers: See recall database entry Manufactured Dates: December 30, 2021 to January 1, 2022; January 15, 2022 to…

May 6, 2022 The U.S. Food and Drug Administration (FDA) is evaluating the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no longer manufactured but…

Summary Company Announcement Date: April 29, 2022 FDA Publish Date: May 02, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia gladioli Company Name: Fagron Inc. Brand Name: Brand Name(s) Product Description: Product Description SyrSpend SF 500mL and 4L Company Announcement FOR IMMEDIATE RELEASE – 04/29/2022 – St. Paul, Minnesota,…