FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on June 7, 2022 - 15:06 GMT

Buzzagogo, Inc. Issues Voluntary Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 7, 2022 - 09:56 GMT

Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 7, 2022 - 09:42 GMT

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 27, 2022 - 13:40 GMT

ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of Smoke or Fire When Lift Is Used with Depleted Battery

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: ArjoHuntleigh Polska Sara Plus floor lift Product Serial Numbers: See recall …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 26, 2022 - 15:29 GMT

Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm

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: Dragonfly OpStar Imaging Catheter Product Lot Numbers: See recall database entry …

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Published on May 25, 2022 - 19:15 GMT

Urgent Voluntary Recall: CorneaGen Cornea/ Cornea Patch Grafts; CorneaGen is voluntarily recalling Corneal Patch Grafts bearing ...

Firm: CorneaGen 1200 6th Ave Suite 300 Seattle, WA 98101 T: 206-701-5840 Product Numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103 On January 5, 2022, CorneaGen discovered that Cornea Patch Grafts were obtained from a donor …

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Published on May 23, 2022 - 19:07 GMT

Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 19, 2022 - 21:18 GMT

2022 Biologics Recalls

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 19, 2022 - 20:59 GMT

Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral ...

Firm: CorneaGen 1200 6th Ave Suite 300 Seattle, WA 98101 T: 206-701-5840 Lot Number: W419221008338 Product Numbers: W419221008338005; W419221008338006; W419221008338007; W419221008338008; W419221008338009; W419221008338010; W419221008338011; …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 19, 2022 - 20:19 GMT

Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA ...

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 …

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Published on May 19, 2022 - 19:59 GMT

FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

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. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 16, 2022 - 17:48 GMT

Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (...

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 13, 2022 - 20:42 GMT

Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 12, 2022 - 09:28 GMT

UPDATE: Impella RP System Post-Approval Study Results and Updated Labeling - Letter to Health Care Providers

December 5, 2022 The U.S. Food and Drug Administration (FDA) is issuing this update to our previous letter to health care providers to inform the health care community of the final post-approval study (PAS) results and updated labeling for the Impella RP …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 11, 2022 - 20:27 GMT

Insulet Issued Voluntary Medical Device Correction for Omnipod DASH® Personal Diabetes Manager on October 17, 2022

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 10, 2022 - 16:28 GMT

SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or ...

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 10, 2022 - 15:41 GMT

Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication

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 …

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Published on May 9, 2022 - 14:55 GMT

Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2022 - 17:41 GMT

Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – ...

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 …

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Published on April 28, 2022 - 21:03 GMT

Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, ...

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: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Codes: 83QKP Lot Numbers: See …

Distribution channels: Healthcare & Pharmaceuticals Industry