Summary Company Announcement Date: January 12, 2022 FDA Publish Date: January 12, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Hub cap and seal on the proximal end of the device handle may detach during use Company Name: Oscor Inc. Brand Name: Brand Name(s) Product Description: Product Description Destino Twist 14F model…

[Posted 01/12/2022] AUDIENCE: Dentistry, Anesthesiology, Patient, Health Professional, Pharmacy ISSUE:  The FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth.  The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of…

The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2022 Safety Communications Content current as of: 01/13/2022 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications

Summary Company Announcement Date: January 11, 2022 FDA Publish Date: January 12, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential microbial contamination Company Name: Lohxa LLC Brand Name: Brand Name(s) Product Description: Product Description Senna Syrup 5mL Company Announcement FOR IMMEDIATE RELEASE – 01/11/2022 – Worcester, MA. Lohxa LLC is voluntarily recalling…

Date Issued: January 11, 2022 The U.S. Food and Drug Administration (FDA) is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false…

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 (Include the following information) Product Names: WIRION Embolic Protection Device Product Codes: See Recall Database Entry Model Numbers: All products and lots Manufacturing Dates: January 3, 2021…

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: Synergy Cranial and StealthStation S7 Cranial Software Model Numbers: See Recall Database Entry  Distribution Dates:  May 1, 2019 to October 29, 2021 Devices Recalled in…

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: Puritan Bennett 980 Series Ventilator Model Numbers: See Recall Database Entries  Distribution Dates:  February 23, 2017 to April 4, 2020 Devices Recalled in the U.S.:…

The list below contains recalls that were issued in 2022. 2022 Medical Device Recalls Content current as of: 01/03/2022 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls

Summary Company Announcement Date: December 27, 2021 FDA Publish Date: December 30, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Ralstonia pickettii bacteria Company Name: Taro Pharmaceuticals USA, Inc. Brand Name: Brand Name(s) Product Description: Product Description Clobetasol Propionate Company Announcement FOR IMMEDIATE RELEASE – Hawthorne, NY, December 27, 2021 ─…