FDA Press Releases

• Published on August 9, 2022 - 16:49 GMT

  

  Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers 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. Recalled Product Device Use Haimen Shengbang Laboratory Equipment Co. Ltd.’s Viral Transport Media Container is a …

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• Published on August 9, 2022 - 15:03 GMT

  

  Abbott MitraClip Device: Potential for Clip Lock Malfunctions - Letter to Health Care Providers

  September 8, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care providers about potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott. On September 8, 2022, Abbott issued an Urgent Medical Device …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 9, 2022 - 13:03 GMT

  

  Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication

  Date Issued: September 8, 2022 The U.S. Food and Drug Administration (FDA) is informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. The …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 29, 2022 - 21:17 GMT

  

  Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene

  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 …

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• Published on July 28, 2022 - 18:33 GMT

  

  Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub Defect

  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: Palindrome and Mahurkar Hemodialysis Catheters Product Codes: MSD Model Numbers: …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 26, 2022 - 18:21 GMT

  

  Vi-Jon, LLC Expands Voluntary Nationwide Recall of All Flavors and Lots Within Expiry of Magnesium Citrate Saline Laxative Oral ...

  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 July 25, 2022 - 17:19 GMT

  

  Ultra Supplement LLC Issues Voluntary Nationwide Recall of Sustango Due to the Presence of Undeclared Tadalafil

  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 July 25, 2022 - 15:09 GMT

  

  Baxter Healthcare Corporation Recalls Abacus Order Entry and Calculation Software for Risk of Medication Label Errors

  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: Abacus Order Entry and Calculation Software Product Codes: See medical device …

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• Published on July 21, 2022 - 17:10 GMT

  

  UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 21, 2022 - 15:58 GMT

  

  Voluntary Recall of Certain Over-the-Counter Products

  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 …

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• Published on July 20, 2022 - 15:12 GMT

  

  Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion ...

  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  Device Use Smiths Medical Medfusion 4000 and 3500 Syringe Infusion Pumps are used to give fluids …

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• Published on July 19, 2022 - 17:59 GMT

  

  MKS Enterprise LLC Voluntary Recalls of Dose Vital VIP Vital Honey Due to Presence of Undeclared Tadalafil

  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 …

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• Published on July 15, 2022 - 19:05 GMT

  

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on July 15, 2022 - 17:28 GMT

  

  Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to 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 July 14, 2022 - 00:15 GMT

  

  Hospira Issues a Voluntary Nationwide Recall for One Lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol), Due to ...

  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 July 13, 2022 - 18:18 GMT

  

  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 …

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• Published on July 11, 2022 - 10:58 GMT

  

  Adam’s Polishes, LLC Issues Voluntary Nationwide Recall of Hand Sanitizer Due to Potential Contamination With Methanol

  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 30, 2022 - 19:46 GMT

  

  Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United ...

  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 …

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• Published on June 30, 2022 - 18:59 GMT

  

  Copiktra (duvelisib): Drug Safety Communication - FDA Warns about Possible Increased Risk of Death and Serious Side Effects

  [Posted 06/30/2022] AUDIENCE: Patient, Health Professional, Pharmacy, Oncology  ISSUE: The FDA is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 30, 2022 - 15:41 GMT

  

  Update: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA ...

  Date Issued: June 30, 2022 The U.S. Food and Drug Administration (FDA) is updating the May 2021 Safety Communication to alert the public that Capitol Radiology, LLC, doing business as Laurel Radiology Services, located in Laurel, Maryland is currently …

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