Tag: fda

FDA Issues Early Alert for Baxter Volara System Circuits Due to Leakage Risk

11 Jun 2026 1:15 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert regarding Baxter's Volara System single-patient use circuits, which may leak air and medication. This issue can lead to ineffective therapy and patient desaturation.

Health Business Science & Technology Medical Science Legal Social Issues Baxter Volara System FDA Medical Device Correction Air Leakage Patient Safety Medical Devices Food Recalls Drugs
FDA Approves New Kidney Risk Warnings for OTC Weight Loss Drug alli

10 Jun 2026 1:18 p.m. · Source: US Food and Drug Administration

The FDA has approved new labeling for the OTC weight loss drug alli (orlistat) 60 mg, warning of rare risks including acute kidney injury and kidney stones. Consumers with a history of kidney issues should consult a doctor before use.

Health Politics and Government Medical Science Federal Government Education FDA alli orlistat kidney injury kidney stones weight loss Drug Safety Food Recalls Drugs
Clover Hill Dairy Recalls Ricotta Cheese Over Listeria Risk

9 Jun 2026 4:28 p.m. · Source: US Food and Drug Administration

Clover Hill Dairy has issued a voluntary recall for all Soft Ricotta/Requeson Cheese due to potential Listeria monocytogenes contamination. The cheese, distributed across six states and D.C., may be linked to eight reported infections.

Health Business Politics and Government Medical Science Federal Government State Governments Legal Social Issues Clover Hill Dairy Soft Ricotta/Requeson Cheese Listeria monocytogenes Product Recall Food Safety Mechanicsville, Maryland FDA Food Recalls Drugs
Go Raw LLC Expands Pet Food Recall for Low Thiamine in Chicken Recipe

9 Jun 2026 4:27 p.m. · Source: US Food and Drug Administration

Go Raw LLC has expanded its voluntary recall of Steve’s Real Food Freeze-Dried Chicken Recipe. The recall is due to potentially low thiamine levels, which can cause serious health issues in pets, especially cats.

Health Business Politics and Government Medical Science Legal Education Social Issues Product Recall Go Raw LLC Steve's Real Food Freeze-Dried Chicken Recipe Thiamine Deficiency Pet Health FDA Food Recalls Drugs
BD Recalls ChloraPrep and FREPP Applicators Due to Fungal Contamination Risk

9 Jun 2026 4:25 p.m. · Source: US Food and Drug Administration

BD has voluntarily recalled specific lots of ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL applicators due to potential fungal contamination with Aspergillus penicillioides, which could lead to serious infections.

Health Business Medical Science Legal Education Product Recall BD ChloraPrep FREPP Fungal Contamination Aspergillus penicillioides Medical Devices Food Recalls FDA Drugs
Media Monitor: FDA Approves New Sunscreen Additive

9 Jun 2026 1:01 p.m. · Source: Washington Post

The Washington Post reports the FDA has approved a new sunscreen additive, marking the first such approval in two decades, following years of advocacy from consumer groups.

Health Politics and Government Medical Science Federal Government General Politics Social Issues FDA sunscreen additive approval consumer groups regulation The Washington Post
FDA Seeks Public Comment on Removing 510(k) Clearance for Federal Drug Testing

9 Jun 2026 9:31 a.m. · Source: DOT - Office of Drug & Alcohol Policy & Compliance

The FDA proposes removing the 510(k) clearance requirement for federal drug testing programs, including DOT's. This change impacts laboratories and testing providers. The DOT urges stakeholders to review the proposal and submit comments by June 30, 2026.

Politics and Government Health Business Federal Government General Politics Medical Science Employment and Labor Legal FDA Department of Transportation Drug Testing 510(k) Clearance Federal Register Public Comment Regulatory Policy DOT - Office of Drug & Alcohol Policy & Compliance
Nelson & Isa Lacteos LLC Recalls Requeson Cheese Over Listeria Risk

8 Jun 2026 4:53 p.m. · Source: US Food and Drug Administration

Nelson & Isa Lacteos LLC is recalling 1lb Requeson Cheese packages sold in New York from May 15-28, 2026, due to potential Listeria monocytogenes contamination. No illnesses have been reported yet.

Health Business Politics and Government Medical Science Legal State Governments Federal Government Social Issues Nelson & Isa Lacteos LLC Requeson Cheese Listeria monocytogenes Product Recall New York Food Safety Public Health Food Recalls FDA Drugs
BD Recalls ChloraPrep and FREPP Applicators Over Fungal Contamination Risk

8 Jun 2026 2:22 p.m. · Source: US Food and Drug Administration

BD has recalled specific lots of ChloraPrep and FREPP applicators due to Aspergillus penicillioides contamination. This poses risks of serious infection, sepsis, and death, prompting immediate discontinuation and destruction of affected units.

Health Medical Science Federal Government Legal Social Issues BD ChloraPrep FREPP Product Recall Aspergillus penicillioides FDA Medical Devices Food Recalls Drugs
FDA Issues Early Alert on Hamilton Medical Breathing Circuit Sets

8 Jun 2026 12:47 p.m. · Source: US Food and Drug Administration

FDA issues an Early Alert regarding Hamilton Medical coaxial breathing circuit sets. Certain lots may not perform as intended, leading to impaired exhalation and four reported serious injuries.

Health Business Science & Technology USA Medical Science Federal Government FDA Hamilton Medical Breathing Circuit Sets Medical Devices Early Alert Respiratory Compromise Patient Safety Food Recalls Drugs
Target Recalls Up & Up Baby Wipes Over Microbial Contamination Risk

5 Jun 2026 5:03 p.m. · Source: US Food and Drug Administration

Target has recalled its Up & Up baby wipes due to contamination with "Burkholderia cepacia" complex and "Burkholderia gladioli." These bacteria pose a risk of serious infections, especially for vulnerable infants and children. Consumers should return the wipes for a…

Health Business Medical Science Federal Government Social Issues Legal Product Recall Target Baby Wipes Microbial Contamination Burkholderia cepacia Infant Health FDA Food Recalls Drugs
FDA Issues Early Alert for GE HealthCare Infant Resuscitation Systems Over Oxygen Delivery Risk

5 Jun 2026 2:50 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for GE HealthCare Infant Resuscitation Systems due to loose blender knob shafts. This defect could cause incorrect oxygen delivery, posing risks of hypoxia or hyperoxia to infants, though no serious injuries are reported.

Health Business Politics and Government Medical Science Federal Government Legal Social Issues GE HealthCare Infant Resuscitation Systems FDA Medical Devices Oxygen Concentration Product Recall Patient Safety Food Recalls Drugs
Target Recalls Up & Up Baby Wipes Over Bacterial Contamination Risk

5 Jun 2026 1:48 p.m. · Source: US Food and Drug Administration

Target is recalling Up & Up baby wipes due to contamination with Burkholderia cepacia complex and Burkholderia gladioli. These bacteria can cause serious infections, especially in vulnerable populations. Consumers should stop use and return products for a full refund.

Health Business Medical Science Legal Economy Social Issues Target Up & Up Baby Wipes Product Recall Burkholderia cepacia complex Burkholderia gladioli FDA Consumer Products Food Recalls Drugs
Haleon Recalls Gas-X Extra Strength Softgels Over Potential Coolant Contamination

5 Jun 2026 1:45 p.m. · Source: US Food and Drug Administration

Haleon is recalling four lots of Gas-X Extra Strength Softgels due to potential coolant contamination. Consumers should check lot numbers and contact Haleon for returns, though no adverse events have been reported.

Health Business Medical Science Legal Economy Social Issues Haleon Gas-X Extra Strength Softgels Product Recall Propylene Glycol FDA Drugs Warren, N.J.Food Recalls
Prime Food Processing Recalls "Dried Herring Fish" Over Botulism Risk

5 Jun 2026 1:44 p.m. · Source: US Food and Drug Administration

Prime Food Processing LLC is recalling "Dried Herring Fish" due to inadequate evisceration, violating regulations and posing a botulism risk. The product was distributed in multiple states, though no illnesses have been reported.

Health Business Politics and Government Medical Science Federal Government State Governments Trade Agriculture Prime Food Processing LLC Dried Herring Fish Product Recall Botulism Food Safety New York Department of Agriculture and Markets Vietnam Food Recalls FDA Drugs
FDA, CDC Investigate Listeria Outbreak Linked to Recalled Requeson Cheese

5 Jun 2026 12:53 p.m. · Source: US Food and Drug Administration

An ongoing FDA and CDC investigation links a multi-state Listeria outbreak, causing 8 illnesses and 1 death, to recalled Clover Hill Dairy requeson cheese. Consumers are urged to avoid the product and clean contaminated surfaces.

Health Politics and Government Business Federal Government Medical Science Social Issues Agriculture Education Listeria monocytogenes Requeson Soft Ricotta Cheese Clover Hill Dairy FDA CDC Product Recall Food Safety Outbreak Investigation Food Recalls Drugs
Haleon Recalls Gas-X Extra Strength Softgels Due to Chemical Contamination

5 Jun 2026 7:43 a.m. · Source: US Food and Drug Administration

Haleon has recalled specific lots of Gas-X Extra Strength Softgels due to potential contamination with a diluted propylene glycol-based coolant. Consumers are advised to stop use and contact Haleon for reimbursement, though no adverse events have been reported.

Health Business Politics and Government Medical Science Federal Government Legal Gas-X Haleon Product Recall Chemical Contamination Softgels FDA Pharmaceuticals Food Recalls Drugs
FDA Issues Early Alert on Insulet Omnipod Insulin Pump Under-Delivery Risk

4 Jun 2026 3:31 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert concerning Insulet Omnipod insulin pumps. Certain Pods may have a cannula tear, leading to insulin under-delivery. Affected models include Omnipod 5, DASH, and Eros, prompting a customer removal recommendation.

Health Business Science & Technology Medical Science Federal Government Insulet Omnipod Insulin Pump FDA Medical Device Product Recall Insulin Under-delivery Food Recalls Drugs
Becton Dickinson Issues Correction for Spinal Trays with Bupivacaine Ampules

4 Jun 2026 10:37 a.m. · Source: US Food and Drug Administration

Becton Dickinson is correcting BD Spinal Trays by removing bupivacaine ampules due to quality issues and potential ineffectiveness. The FDA deems this a serious recall, warning of risks like infection or reduced anesthetic effect.

Health Business Politics and Government Medical Science Federal Government Economy Becton Dickinson BD Spinal Trays Bupivacaine Huons Co. Ltd.FDA Product Recall Anesthesia Food Recalls Drugs
Total Nutrition Expands Recall of Moringa Capsules Over Salmonella Risk

4 Jun 2026 8:54 a.m. · Source: US Food and Drug Administration

Total Nutrition has expanded its recall of TNVitamins and Doctor's Pride Ultra Potent Complete Green Superfood Moringa Capsules due to potential Salmonella contamination, posing serious health risks. Customers should dispose of products and seek refunds.

Health Business Politics and Government Medical Science Federal Government Social Issues Education Salmonella Product Recall Total Nutrition TNVitamins Doctor's Pride Moringa Capsules FDA Food Recalls Drugs
Total Nutrition Inc. Expands Recall of Moringa Capsules Over Salmonella Risk

3 Jun 2026 4:13 p.m. · Source: US Food and Drug Administration

Total Nutrition Inc. has expanded its recall of TNVitamins and Doctor's Pride Ultra Potent Complete Green Superfood Moringa Capsules due to potential Salmonella contamination. The products were sold nationally online, posing serious health risks, especially to vulnerable populations.

Health Business Medical Science Economy Social Issues Legal Total Nutrition Inc.Product Recall Moringa Capsules Salmonella Food Safety Dietary Supplements Deer Park, NY Food Recalls FDA Drugs
FDA Recommends Alternatives to Hintermann Ankle Replacement System Due to Failure Risks

3 Jun 2026 2:05 p.m. · Source: US Food and Drug Administration

The FDA advises considering alternative treatments to the Hintermann Series H3 Total Ankle Replacement System due to elevated long-term risks. Device failure, revision surgery, and polyethylene fracture are among the concerns for the DT MedTech LLC product.

Health Politics and Government Medical Science Federal Government Legal Social Issues Hintermann Series H3 Total Ankle Replacement FDA DT MedTech LLC Device Failure Revision Surgery Polyethylene Fracture Food Recalls Drugs
FDA Warns of Blood Clot Risk with Abiomed Introducer Kits

2 Jun 2026 6:13 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for Abiomed's 14Fr Low Profile Introducer Kits due to a high rate of complaints regarding thrombus formation. This issue has led to three serious injuries, prompting Abiomed to recommend removal of all affected…

Health Business Science & Technology Medical Science Federal Government Legal Abiomed FDA 14Fr Low Profile Introducer Kit Thrombus Formation Medical Device Product Recall Patient Safety Food Recalls Drugs
NIH Advances Experimental Opioid Use Disorder Treatment with Mitragynine Trial

1 Jun 2026 4:26 p.m. · Source: National Institutes of Health

NIH's Investigational New Drug application for mitragynine, a kratom compound, is now active, enabling a Phase I clinical trial. This study will assess the safety and tolerability of mitragynine as a potential new treatment for opioid use disorder, addressing high…

Health Science & Technology Medical Science Federal Government Social Issues NIH Opioid Use Disorder Mitragynine Kratom Clinical Trial FDA Drug Development National Institutes of Health
Champion Foods Recalls Motor City Pizza Co. 5 Cheese Bread Over Salmonella Risk

1 Jun 2026 4:05 p.m. · Source: US Food and Drug Administration

Champion Foods recalls Motor City Pizza Co. 5 Cheese Bread due to potential Salmonella contamination. The voluntary recall stems from a milk powder recall, though no illnesses are reported, taken out of caution for consumer safety.

Health Business Politics and Government Federal Government Medical Science Agriculture Social Issues Product Recall Food Safety Salmonella Champion Foods Motor City Pizza Co.Cheese Bread Michigan Food Recalls FDA Drugs
KayserBetten Issues Urgent Correction for IDA Pediatric Care Beds Amid Serious Injury Risk

30 May 2026 7:07 a.m. · Source: US Food and Drug Administration

KayserBetten is correcting its IDA pediatric care beds due to a serious entrapment risk, identified as a Class I recall. A free hand control replacement with automatic locking will be provided to prevent injury or death.

Health Business Medical Science Legal Social Issues KayserBetten IDA pediatric care beds Product Recall Class I Recall Medical Device Child Safety Entrapment Risk Food Recalls FDA Drugs
Media Monitor: Wall Street Journal Editorial Board Covers Newsom's AI Plan, FDA Drug Reversal, and Trump's NATO Strategy

30 May 2026 5:10 a.m. · Source: Wall Street Journal Editorial Board

The Wall Street Journal Editorial Board is reporting on California Gov. Gavin Newsom's AI proposals, an FDA reversal on a melanoma drug, and questions surrounding Donald Trump's NATO approach.

Politics and Government Business Science & Technology Health General Politics Federal Government State Governments Economy Artificial Intelligence Education Gavin Newsom FDA NATO Donald Trump University of California Standardized Testing Wall Street Journal Editorial Board
Better Weather Fix Elixir Recalled Due to Undeclared Potent Substances

29 May 2026 4:22 p.m. · Source: US Food and Drug Administration

Better Weather Actives LLC has issued a nationwide recall for all lots of its Better Weather Fix Elixir. The product contains undeclared Mitragynine and its potent derivative, Mitragynine Pseudoindoxyl, posing risks of severe adverse effects, including respiratory suppression and addiction.

Health Business Medical Science Legal Social Issues Product Recall Better Weather Fix Elixir Mitragynine Mitragynine Pseudoindoxyl Kratom Sheridan, Wyoming US Food and Drug Administration Food Recalls FDA Drugs
Dexcom Recalls Stolen G7 Glucose Sensors Following Third-Party Theft

29 May 2026 4:22 p.m. · Source: US Food and Drug Administration

Dexcom has recalled two lots of G7 continuous glucose monitoring sensors, 1725204004 and 1725069002, after they were stolen during destruction and sold by unauthorized third parties, posing risks of infection or device failure. Users should seek replacements.

Health Business Law Enforcement Medical Science Legal Education Economy Social Issues Dexcom G7 sensors Product Recall Medical Devices Diabetes Theft Pharmsource LLC Food Recalls FDA Drugs
Better Weather Actives Recalls Elixir Over Undeclared Mitragynine and Potent Derivative

29 May 2026 9:12 a.m. · Source: US Food and Drug Administration

Better Weather Actives is recalling all lots of its Fix Elixir nationwide due to undeclared Mitragynine and its potent derivative, Mitragynine Pseudoindoxyl, posing risks of severe health effects and addiction. Consumers should stop use and return the product.

Health Business Medical Science Legal Education Social Issues Product Recall Better Weather Fix Elixir Mitragynine Mitragynine Pseudoindoxyl Dietary Supplements FDA Consumer Safety Food Recalls Drugs