February 29, 2024 The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers and facilities about the safe use of electrical operating room tables. The FDA has received reports of adverse events associated with electrical operating room tables and is providing recommendations for health care providers to help protect patients. …
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, manufactured by DT MedTech LLC. The FDA is evaluating interim post-approval study (PAS) results for the Hintermann Series…
Megadyne Reiterates Intended Use Population Change for Megadyne Mega Soft Universal and Universal Plus Patient Return Electrodes
Summary Company Announcement Date: February 29, 2024 FDA Publish Date: February 29, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Limit use to patients aged 12 years or older. Company Name: Megadyne Medical Products, Inc. Brand Name: Brand Name(s) Product Description: Product Description Mega Soft Universal and Universal Plus Reusable Patient Return…
Datex-Ohmeda Recalls EVair Air Compressors Due to Formaldehyde Emissions Found in Specific Conditions When Used with CARESCAPE R860, Engstrom Carestation or Pro Ventilators
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: EVair air compressors (model numbers M1230849, M1230847) EVair-03 air compressors (Jun-air; model numbers 1609000, 1609002) EvAir CPRSR Kits (model numbers M1230849, M1230847) Product Codes: See…
Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door Latch
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, Care Plus Models 1000 through 4000 and Lullaby Incubator, Lullaby Incubator…
Avanos Medical, Inc. Announces Voluntary Recall in Response to Nurse Assist, LLC Sterile Water Medical Products Recall
Summary Company Announcement Date: February 21, 2024 FDA Publish Date: February 27, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential Lack of Sterility Assurance Company Name: Avanos Medical, Inc. Brand Name: Brand Name(s) Avanos Medical Product Description: Product Description MIC* Gastric-Jejunal Feeding Tube Kits Company Announcement ALPHARETTA, Ga., Feb. 7, 2024…
BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication
Date Issued: February 27, 2024 The U.S. Food and Drug Administration (FDA) is informing patients and health care providers about the potential risk of serious complications with the use of BioZorb Marker and BioZorb LP Marker devices by Hologic, Inc. The BioZorb Marker and BioZorb LP Marker are devices implanted in soft tissue, including breast…
Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment Due to Potential Lack of Sterility
Summary Company Announcement Date: February 22, 2024 FDA Publish Date: February 26, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Potential Lack of Sterility Assurance. Company Name: Brassica Pharma Pvt. Ltd. Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Eye ointment products Company Announcement FOR IMMEDIATE RELEASE – 12…
Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication
Date Issued: February 21, 2024 The U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin. These devices are different than smartwatch applications that display data from FDA-authorized…
Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software Versions
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: Medfusion syringe pump Product Codes: FRN Model Numbers: Model 4000 syringe pump Distribution…