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…
Keeping Your Milk Safe From the Grass to the Glass
Image Español Milk is one of the safest foods we can consume in the U.S. today. That wasn’t always the case. If you look back 100 years, milk was second only to water as a vehicle for transmitting disease, as noted in a 1924 U.S. Public Health Service article. Back then, people were getting sick…
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…
5 Medication Safety Tips for Older Adults
Image Español Whether you’re settling into your 60s or heading into your 90s, be careful when taking medicines, herbal preparations and supplements. Why the special concern? The older we get, the more likely we are to use more prescription and nonprescription (or over-the-counter, OTC) medicines. That can increase the chance of harmful side effects and…
Philips Recalls BrightView Imaging Systems Due to the Detector Unexpectedly Falling
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: BrightView, BrightView X, BrightView XCT Product Codes: See Recall Database Entry Model Numbers:…
Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Nurse Assist Sterile Saline Placed Into the Following Kits; AMS10833 Local Lower Extremity Pack I, AMS12947 In House Ocular Pack, AMS12947A In House Ocular Pack and AMS13043 Closure Kit
Summary Company Announcement Date: January 22, 2024 FDA Publish Date: January 23, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product cannot be verified as having the required sterility assurance level Company Name: Aligned Medical Solutions Brand Name: Brand Name(s) Aligned Medical Solutions Product Description: Product Description Convenience kits containing saline Company…
Haleon Issues Voluntary Nationwide Recall of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products Due to Microbial Contamination
Summary Company Announcement Date: January 24, 2024 FDA Publish Date: January 24, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial Contamination Company Name: Haleon Brand Name: Brand Name(s) Robitussin Product Description: Product Description Cough syrups Company Announcement FOR IMMEDIATE RELEASE – January 24, 2024 – Warren, NJ, Haleon is voluntarily recalling eight…