FDA Press Releases

• Published on June 27, 2024 - 17:18 GMT

  

  Ventilator Correction: ZOLL Medical Corporation Updates Use Instructions For 731 Ventilators Due to Missing MRI Safety Information ...

  This recall involves updating instructions for using 731 Ventilator devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 27, 2024 - 16:09 GMT

  

  Continuous Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions for BiPAP V30, BiPAP A30, BiPAP A40 Due to ...

  This recall involves updating instructions for using BiPAP V30, BiPAP A30, BiPAP A40 devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 26, 2024 - 18:56 GMT

  

  American Health Packaging on Behalf of BluePoint Laboratories Issues Voluntary Nationwide Recall for Potassium Chloride Extended-...

  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 25, 2024 - 15:06 GMT

  

  Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 ...

  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 13, 2024 - 20:58 GMT

  

  Electrode Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for Risk of Serious Burn Injuries to ...

  This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Figure 1: MEGADYNE MEGA SOFT …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 13, 2024 - 20:08 GMT

  

  Getinge Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient and Health Care Professional Exposure to Toxic Chemical ...

  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: Vaporizer Sevoflurane Maquet Filling Product Code: 6682282 Distributed Serial Numbers …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 13, 2024 - 19:30 GMT

  

  Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits for Manufacturing ...

  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. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Name: Arrow FiberOptix …

  Distribution channels:
• Published on June 12, 2024 - 16:44 GMT

  

  Suntegrity Skincare Issues Voluntary Recall of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) 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 Summary Company …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 12, 2024 - 07:48 GMT

  

  Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator ...

  The devices described in this recall are the same devices announced in the related Letter to Health Care Providers. On November 8, 2024 the FDA issued an update to the Letter to Health Care Providers to provide the most recent recommendations provided by …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 11, 2024 - 21:10 GMT

  

  Male Enhancement Supplements Recalled

  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 June 11, 2024 - 16:06 GMT

  

  Endotracheal Tube Recall: Medline Industries, LP Removes Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to ...

  This recall involves removing devices from where they are used or sold.  The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Medline Sub-G …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 11, 2024 - 15:20 GMT

  

  VitalityVita Issues Voluntary Nationwide Recall of VitalityXtra and PeakMax Capsules Due to the Presence of Undeclared Sildenafil ...

  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 9, 2024 - 10:25 GMT

  

  Related Recalls - Plastic Syringes Made in China for Potential Device Failures

  Jiangsu Shenli Medical Production Co., Ltd. MEDLINE SYR 30ML/LS Jiangsu Shenli Medical Production Co., Ltd. MEDLINE SYR 30ML L/L Jiangsu Shenli Medical Production Co., Ltd. MEDLINE SYR 60ML L/S Jiangsu Shenli Medical Production Co., Ltd. MEDLINE SYR 60ML L …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 8, 2024 - 15:10 GMT

  

  Nerve Monitoring System Correction: Medtronic Issues Correction for NIM Vital Nerve Monitoring System due to the Potential for ...

  This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 8, 2024 - 14:20 GMT

  

  Ambulatory Infusion Pump Software Correction: Smiths Medical Issues Correction for CADD-Solis and CADD-Solis VIP Ambulatory ...

  This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on June 8, 2024 - 11:05 GMT

  

  Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium 0.9% Sodium Chloride Injection Due to Potential for ...

  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 30, 2024 - 17:29 GMT

  

  OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC

  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: Optum Nimbus II Plus Ambulatory Infusion System Product Codes: See Recall Database …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 29, 2024 - 19:24 GMT

  

  Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate ...

  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 23, 2024 - 16:47 GMT

  

  Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use

  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: Twin Tube Product Codes: BZC Model Numbers: V-707327 Distribution Dates: January 1, …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on May 22, 2024 - 18:31 GMT

  

  Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices

  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.  Please be aware, this recall is a correction, not a product removal.   Recalled Product  Product Names: BioZorb …

  Distribution channels: Healthcare & Pharmaceuticals Industry