Summary Company Announcement Date: July 14, 2021 FDA Publish Date: July 14, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Testing identified low levels of benzene Company Name: Johnson & Johnson Brand Name: Brand Name(s) Neutrogena, Aveeno Product Description: Product Description Company Announcement Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all…
Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers
July 8, 2021 The U.S. Food and Drug Administration (FDA) is informing health care providers about potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. The FDA is also providing health care providers with recommendations for monitoring patients with these devices, which include the following: Stainless Steel (Biodur…
Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative 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 Lyra SARS-CoV-2 Assay (M120) Lot codes: 031620A, 031620B, 031620C, 032320, 032420, 032720, 032820A, 032820B, 040320, 040720, 040920, 041020, 174992, 175429, 175501, 175502, 175503, 176001, 176002, 176366, 176367,…
Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities
June 30, 2021 The U.S. Food and Drug Administration (FDA) is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems (revocation effective June 30, 2021). As of the effective date of the revocations, these devices will no longer be authorized…
Teva Initiates Voluntary Nationwide Recall of One Lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) Due to Presence of Particulate Matter
Summary Company Announcement Date: June 30, 2021 FDA Publish Date: July 01, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter Company Name: Teva Pharmaceuticals Brand Name: Brand Name(s) Product Description: Product Description Topotecan Injection 4 mg/4 mL (1 mg/mL) Company Announcement Teva Pharmaceuticals has initiated a voluntary recall of…
Ardil Comercial Issues Voluntary Nationwide Recall of Limar Hand Sanitizer Packaged in 4 oz Bottles Because They Resemble Drink Containers
Summary Company Announcement Date: July 01, 2021 FDA Publish Date: July 01, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaged in bottles that resemble drink containers Company Name: Ardil Commercial Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer Company Announcement Santo Domingo, Dominican Republic – Ardil Comercial is voluntarily recalling…
Medtronic Vascular Recalls Angiographic Guidewire Component Due to Being Non-sterile
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 Angiographic Guidewire Component Model Numbers: WIRE ANGIO 107042 PNS .035X145 3MMJ PTFE; Part No: 107042 WIRE ANGIO 107044 PNS .038X145 3MMJ PTFE; Part No: 107044 WIRE ANGIO…
Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low 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. Recalled Product LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Lot codes: LeadCare II: 2013M, 2014M, 2015M, 2016M, 2017M, 2101M, 2103M, 2105M, 2106M, and 2107M LeadCare Plus and LeadCare…
Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
Date Issued: June 30, 2021 The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to…
Stop Using Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication
Date Issued: June 10, 2021 The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, labeling…