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There were 1,923 press releases posted in the last 24 hours and 359,061 in the last 365 days.

FDA Press Releases

2,265 Press Releases

Published on March 25, 2024 - 17:46 GMT

Medline Industries Recalls Certain Kits and Trays Containing Sterile Water Based Products Under Recall by Nurse Assist

Please be aware, this recall is a correction, not a product removal. 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: Medline Kits …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on March 21, 2024 - 18:44 GMT

Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing Defect That Can Lead to Injury or Death

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 and Codes: AirLife™ Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask …

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Published on March 21, 2024 - 14:56 GMT

Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks

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

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on March 20, 2024 - 20:46 GMT

Voluntary Removal Announcement for the InfuTronix Nimbus Ambulatory Infusion Pump System

Summary Company Announcement Date: March 20, 2024 FDA Publish Date: March 20, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Recall due to a high number (3698) of customer complaints related to the Nimbus Infusion …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on March 20, 2024 - 18:07 GMT

Pyramid Wholesale Issues Recall of Various Brands of Products Sold as Dietary Supplements for Sexual Enhancement Because They ...

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 March 19, 2024 - 18:45 GMT

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

Date Issued: March 19, 2024 The U.S. Food and Drug Administration (FDA) is providing an update on our ongoing evaluation of quality and performance issues related to plastic syringes made in China, and announcing additional recommendations and actions the …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on March 18, 2024 - 15:48 GMT

Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets Due to Potential Interference with Certain ...

Summary Company Announcement Date: March 01, 2024 FDA Publish Date: March 18, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential interference with certain medical implants Company Name: Sleepnet Corporation …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on March 14, 2024 - 21:13 GMT

Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist

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 Avanos Medical MIC Gastric-Jejunal Feeding Tube and MIC Gastric-Jejunal Feeding Tube …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on March 12, 2024 - 21:04 GMT

Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone ...

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 March 11, 2024 - 20:01 GMT

Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop

Please be aware, this recall is a correction, not a product removal. 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: …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on March 11, 2024 - 16:05 GMT

Windstone Medical Packaging, Inc. Recalls Local Lower Extremity Pack, In House Ocular Pack and Closure Kit Containing Sterile ...

Please be aware, this recall is a correction, not a product removal. 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 The Windstone …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on March 7, 2024 - 21:04 GMT

Cardinal Health Recalls Sterile Monoject Luer-Lock and Enteral Syringes Due to a Change in 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. Recalled Product Device Use Cardinal Health Monoject disposable syringes are used to inject fluid into or withdraw …

Distribution channels:
Published on March 7, 2024 - 19:56 GMT

Ventec Life Systems Recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded ...

Please be aware, this recall is a correction, not a product removal. 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: VOCSN Patient …

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Published on March 7, 2024 - 17:35 GMT

Medtronic Neurosurgery Recalls Duet External Drainage and Monitoring System Catheter Tubing due to a Potential for the Catheter ...

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 The DUET External Drainage and Monitoring System (EDMS) is used for temporary drainage …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on March 6, 2024 - 19:29 GMT

Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 Due to a Software Error

Please be aware, this recall is a correction, not a product removal. 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 The ExactaMix Pro …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on March 5, 2024 - 21:43 GMT

Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe Pump Due to Issues Associated with Earlier Software Versions

Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: Medfusion syringe pump Product Codes: FRN Model Numbers: Model 3500 syringe pump Distribution Dates: August 9, 2002 to August 15, 2023 Devices Recalled in …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on March 4, 2024 - 09:55 GMT

Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for ...

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: ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on February 29, 2024 - 20:21 GMT

Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication

Date Issued: February 29, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about a higher-than-expected risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system, …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on February 29, 2024 - 19:57 GMT

Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door ...

Please be aware, this recall is a correction, not a product removal. 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: Care Plus, …

Distribution channels:
Published on February 29, 2024 - 19:32 GMT

Megadyne Reiterates Intended Use Population Change for Megadyne Mega Soft Universal and Universal Plus Patient Return Electrodes

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

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