Date Issued: July 21, 2022 The U.S. Food and Drug Administration (FDA) is providing another update on the Renuvion/J-Plasma device system by Apyx Medical about use of the device for certain aesthetic skin procedures. In March 2022, the FDA warned against the use of Renuvion/J-Plasma for procedures intended to improve the appearance of the skin…
Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion Delivery
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: Medfusion Syringe Infusion Pumps Models, Product Codes, and Software Versions: See Recall Database Entries Devices Recalled in the U.S.: 118,055 Dates distributed: October 2004 to…
MKS Enterprise LLC Voluntary Recalls of Dose Vital VIP Vital Honey Due to Presence of Undeclared Tadalafil
Summary Company Announcement Date: July 18, 2022 FDA Publish Date: July 19, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared active pharmaceutical ingredient tadalafil Company Name: MKS Enterprise LLC Brand Name: Brand Name(s) Dose Vital Product Description: Product Description Company Announcement This product was found to contain the undeclared active pharmaceutical ingredient…
For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication
Date Issued: July 15, 2022 The U.S. Food and Drug Administration (FDA) is advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the monkeypox virus. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox…
Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
Summary Company Announcement Date: July 15, 2022 FDA Publish Date: July 15, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination with Gluconacetobacter liquefaciens Company Name: Vi-Jon, LLC Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor Company Announcement July 14, 2022…
American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for Risk of False Results
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: COVID Test Kit Nonsterile and Clean Catch Urine Kit Product Codes: JSM Lot Numbers: See recall database entry Distribution Dates: February 1, 2021, to…
Hospira Issues a Voluntary Nationwide Recall for One Lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol), Due to the Potential Presence of Visible Particulate
Summary Company Announcement Date: July 13, 2022 FDA Publish Date: July 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of visible particulate Company Name: Hospira Inc, A Pfizer Company Brand Name: Brand Name(s) Product Description: Product Description Propofol Injection Emulsion, USP Company Announcement Hospira, Inc., a Pfizer company, is voluntarily…
Getinge USA Sales Inc Recalls Flow-c and Flow-e Anesthesia Systems for Cracked or Broken Suction System Power Switches
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: Flow-c and Flow-e Anesthesia Systems Product Codes: 6887700, 6887900 Product Serial Numbers: See Recall Database Entries Devices Recalled in the U.S.: 64 Dates distributed: June…
Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens
Summary Company Announcement Date: July 05, 2022 FDA Publish Date: July 06, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential for the label to be missing on some pens. Company Name: Mylan Pharmaceuticals Inc. Brand Name: Brand Name(s) Mylan Pharmaceuticals Inc. Product Description: Product Description Insulin Glargine (Insulin glargine-yfgn) Injection Pens Company…
GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down
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: CARESCAPE R860/Engstrom Carestation/Engstrom PRO Ventilator backup batteries and replacement backup batteries manufactured on or after April 1, 2019. Product Model Numbers: See recall database entries:…