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 ZOOM 71 Reperfusion Catheter Product Codes and Lot Numbers: See Recall Database Entry Devices Recalled in the United States: 3,098 Distribution Date: September 23, 2020 to August…
Medtronic Recalls Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks
October 5, 2021 Update: Medtronic has expanded this recall of remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks. Medtronic sent updated instructions to people who use these devices, including instructions to stop using and return the remote controller. If you…
Bayer Issues Voluntary Recall of Specific Lotrimin® and Tinactin® Spray Products Due to the Presence of Benzene
Summary Company Announcement Date: October 01, 2021 FDA Publish Date: October 01, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of benzene Company Name: Bayer U.S. LLC Brand Name: Brand Name(s) Lotrimin® AF and Tinactin® Product Description: Product Description Over the Counter (OTC) antifungal spray products Company Announcement WHIPPANY, N.J., October 1,…
Coppertone® Issues Voluntary Nationwide Recall of Specific Lots of Pure & Simple SPF 50 Spray (2021 Launch), Sport Mineral SPF 50 Spray (2021 Launch), and Travel-Size Coppertone® Sport Spray SPF 50 (1.6OZ) Aerosols Sunscreen Sprays Due to the Presence of Benzene
Summary Company Announcement Date: September 30, 2021 FDA Publish Date: September 30, 2021 Product Type: CosmeticsDrugs Skin Care Products Reason for Announcement: Recall Reason Description Presence of benzene Company Name: Coppertone, owned by Beiersdorf Brand Name: Brand Name(s) Coppertone Product Description: Product Description Coppertone aerosol sunscreen spray products Company Announcement Coppertone, owned by Beiersdorf, is…
Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND: FDA Safety Communication
Date Issued: September 29, 2021 The U.S. Food and Drug Administration (FDA) is warning consumers about the potential risk of injury associated with the use of the Safe-T-Lite UV WAND, manufactured by Max-Lux Corporation Limited. Use of Max-Lux Safe-T-Lite UV WAND may expose the user or any nearby person to unsafe levels of ultraviolet-C (UV-C)…
Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men – Letter to Health Care Providers
September 27, 2021 The U.S. Food and Drug Administration (FDA) is informing health care providers of recent information about the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion (LAAO) device. The FDA is evaluating a study published in the Journal of the American Medical Association…
Eli Lilly and Company Issues Voluntary Nationwide Recall of One Lot of GLUCAGON® Emergency Kit Due to Loss of Potency
Summary Company Announcement Date: September 25, 2021 FDA Publish Date: September 26, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Loss of potency Company Name: Eli Lilly and Company Brand Name: Brand Name(s) Product Description: Product Description Glucagon Emergency Kit Company Announcement Eli Lilly and Company (NYSE: LLY) is voluntarily recalling lot D239382D,…
Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia
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 AMSORB PLUS PREFILLED G-CAN 1.0L Product Codes and Lot Numbers: See Recall Database Entry Devices Recalled in the United States: 214,032 Distribution Date: October 22, 2020 to…
Cordis Recalls SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands Due to Potential for Marker Bands to Move or Dislodge
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 Cordis SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands Lot Numbers: See Database Entry Distribution Dates: January 1, 2019 to July 20, 2021 Devices Recalled in the…
IntegraDose Compounding Services, LLC Issues Voluntary Nationwide Recall of Cefazolin Injection Products Due to a Lack of Sterility Assurance
Summary Company Announcement Date: September 20, 2021 FDA Publish Date: September 21, 2021 Product Type: Drugs Pharmaceutical Quality Reason for Announcement: Recall Reason Description Lack of sterility assurance. Company Name: IntegraDose Compounding Services, LLC Brand Name: Brand Name(s) IntegraDose Compounding Services, LLC Product Description: Product Description Company Announcement Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily…