Tag: fda

FDA Issues Early Alert for Impella Heart Pump Introducer Kits Over Bleeding Risk

18 Jun 2026 4:34 p.m. · Source: US Food and Drug Administration

The FDA issued an Early Alert for Abiomed and Oscor's Introducer Kits used with Impella heart pumps due to potential leakage. Manufacturing issues increase access-site bleeding risk, prompting a recommendation for corrections before continued use to prevent serious complications.

Health Politics and Government Medical Science Federal Government FDA Abiomed Oscor Impella Heart Pump Medical Device Product Recall Bleeding Risk Food Recalls Drugs
FDA Expands Medline Catheter Recall Over Particulate Risk

18 Jun 2026 4:34 p.m. · Source: US Food and Drug Administration

The FDA has expanded a recall of Medline Industries' reprocessed electrophysiology and ultrasound catheters due to potential residual particulates. This Class I recall warns of serious injury or death, though no incidents have been reported.

Health Politics and Government Medical Science Federal Government Legal FDA Medline Industries Catheter Recall Electrophysiology Ultrasound Medical Devices Product Recall Food Recalls Drugs
Fry Pie Factory Recalls Pepperoni Rolls Over Undeclared Milk and Refrigeration Issues

18 Jun 2026 3:24 p.m. · Source: US Food and Drug Administration

Fry Pie Factory recalled 5-ounce Pepperoni Rolls across Ohio and West Virginia due to undeclared milk and improper refrigeration. The products pose a risk of allergic reaction and food-borne illness, though no illnesses are reported.

Health Business Medical Science Legal Social Issues Education Product Recall Fry Pie Factory Pepperoni Rolls Milk Allergen Food Safety Ohio West Virginia Food Recalls FDA Drugs
Clover Hill Dairy Expands Cheese Recall Amid Listeria Outbreak, One Death Reported

18 Jun 2026 3:24 p.m. · Source: US Food and Drug Administration

Clover Hill Dairy has expanded its recall to include all its brand cheese due to potential Listeria contamination. Nine illnesses, eight hospitalizations, and one death are linked to the products, which are sold across six states and D.C.

Health Business Politics and Government Medical Science Legal Education Federal Government Clover Hill Dairy Product Recall Cheese Listeria monocytogenes Food Safety Maryland Public Health Food Recalls FDA Drugs
Media Monitor: NPR Reports on Iran Deal, Federal Reserve, Georgia Primaries and New Sunscreen Approval

17 Jun 2026 6:54 a.m. · Source: NPR

NPR is reporting on Vice President JD Vance's trip to Switzerland for a tentative Iran war deal, the Federal Reserve's new chairman, Georgia primary election results, and the FDA's approval of a new sunscreen ingredient.

Politics and Government Conflict Business World General Politics Federal Government Economy Middle East Election Iran Donald Trump Federal Reserve Georgia Primary FDA Bemotrizinol El Niño NPR Breaking News NPR
Windstone Medical Packaging Recalls Kits Over Contaminated Alcohol Prep Pads

16 Jun 2026 4:55 p.m. · Source: US Food and Drug Administration

Windstone Medical Packaging recalls custom convenience kits due to contaminated Cardinal Health alcohol prep pads. The FDA issued an Early Alert, warning of infection risks from Paenibacillus phoenicis, especially for vulnerable patients.

Health Business Politics and Government Medical Science Federal Government Social Issues Product Recall Medical Devices Windstone Medical Packaging Cardinal Health Alcohol Prep Pads Infection Risk FDA Food Recalls Drugs
Western Mixers Recalls Dark Chocolate Raisins Over Undeclared Peanuts

16 Jun 2026 4:40 p.m. · Source: US Food and Drug Administration

Western Mixers Produce & Nuts is recalling First Street brand Dark Chocolate Raisins in California due to undeclared peanuts, posing a serious allergy risk. No illnesses have been reported yet.

Health Business Medical Science Federal Government Social Issues Western Mixers Produce & Nuts First Street Dark Chocolate Raisins Peanut Allergy Product Recall California Food Safety Food Recalls FDA Drugs
FDA Alerts Providers to Stereotactic Breast Biopsy Needle Shortage

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

The FDA has alerted healthcare providers about a national supply disruption of Stereotactic Breast Biopsy Needles due to supplier issues. This shortage is expected to impact patient care, prompting recommendations for conservation strategies.

Health Business Medical Science Economy Legal Education FDA Stereotactic Breast Biopsy Needles Supply Disruption Medical Device Shortage Breast Biopsy Health Care Providers Food Recalls Drugs
FDA Issues Warning to SNOO Smart Sleeper Manufacturer Over Unauthorized Products and Unsanitary Conditions

15 Jun 2026 6:51 p.m. · Source: US Food and Drug Administration

The FDA has warned Happiest Baby, Inc., maker of SNOO Smart Sleeper, for selling unauthorized sleep sacks and hospital bundles, and for unsanitary refurbished units and mold reports, urging caution for users.

Health Politics and Government Business Medical Science Federal Government Legal Social Issues Education FDA SNOO Smart Sleeper Happiest Baby, Inc.Warning Letter Medical Devices Product Safety Infant Care Food Recalls Drugs
Nara Organics Recalls All Infant Formula Lots Over Botulism Risk After Three Cases Reported

15 Jun 2026 4:02 p.m. · Source: US Food and Drug Administration

Nara Organics has issued a nationwide recall for all lots of its powdered infant formula due to potential Clostridium botulinum contamination, following three reported infant botulism cases. Consumers are advised to stop use immediately.

Health Business Medical Science Social Issues Legal Education Nara Organics Infant Formula Product Recall Clostridium botulinum FDA CDC Target Food Recalls Drugs
Nara Organics Recalls Infant Formula Amid Botulism Risk After Three Hospitalizations

14 Jun 2026 10:30 a.m. · Source: US Food and Drug Administration

Nara Organics has recalled all lots of its infant formula due to potential Clostridium botulinum contamination. This follows three infant botulism cases in babies who consumed the formula, leading to hospitalizations in California, Washington, and Pennsylvania.

Health Business Law Enforcement Medical Science Legal Education Social Issues Nara Organics Infant Formula Product Recall Clostridium botulinum Infant Botulism FDA Target Food Recalls Drugs
Beekeeper's Naturals Recalls Saline Nasal Spray Over Microbial Contamination Risk

12 Jun 2026 7:38 p.m. · Source: US Food and Drug Administration

Beekeeper’s Naturals has recalled a lot of its Saline Nasal Spray sold via Amazon due to microbial contamination, including "Aspergillus spp." The contamination poses serious health risks, especially for vulnerable individuals. Consumers should discontinue use and seek refunds.

Health Business Politics and Government Medical Science Federal Government Legal Beekeeper's Naturals Saline Nasal Spray Product Recall Microbial Contamination Aspergillus spp.Amazon FDA Food Recalls Drugs
Beekeeper’s Naturals Recalls Saline Nasal Spray Over Microbial Contamination

12 Jun 2026 3:59 p.m. · Source: US Food and Drug Administration

Beekeeper’s Naturals is recalling a lot of its Saline Nasal Spray sold on Amazon due to yeast and potential Aspergillus spp. contamination. This poses serious infection risks, especially for vulnerable individuals, with four adverse reactions reported.

Health Business Politics and Government Medical Science Federal Government Legal Social Issues Product Recall Beekeeper’s Naturals Saline Nasal Spray Amazon Microbial Contamination Aspergillus spp.FDA Food Recalls Drugs
Azuma Foods Recalls Tako Wasabi Over Undeclared Fish Allergen

12 Jun 2026 3:58 p.m. · Source: US Food and Drug Administration

Azuma Foods International Inc. is recalling 545 cases of its Tako Wasabi due to undeclared fish, posing a serious allergy risk. The product was distributed across eight states, with specific lot numbers affected. No reactions have been reported.

Health Business Medical Science Legal Social Issues Education Product Recall Azuma Foods International Inc.Tako Wasabi Fish Allergy Hayward California Food Safety Food Recalls FDA Drugs
Total Nutrition Inc. Expands Recall of Superfood Moringa Capsules Over Salmonella Risk

12 Jun 2026 3:54 p.m. · Source: US Food and Drug Administration

Total Nutrition Inc. expanded its recall of TNVitamins and Doctor's Pride Superfood Moringa Capsules due to potential Salmonella contamination. Consumers are urged to dispose of affected products and seek refunds, as the bacteria poses serious health risks.

Health Business Medical Science Federal Government Social Issues Product Recall Salmonella Dietary Supplements Total Nutrition Inc.TNVitamins Doctor's Pride Food Safety Food Recalls FDA Drugs
FDA Warns Against Use of Recalled Bupivacaine Injections from Huons Co., Ltd.

12 Jun 2026 1:31 p.m. · Source: US Food and Drug Administration

Huons Co., Ltd. has recalled Bupivacaine Hydrochloride in Dextrose Injection, USP, due to quality issues. Medline advises customers to remove these injections from convenience kits, as their use poses risks of infection, inflammation, and severe neurological complications.

Health Business Politics and Government Medical Science Federal Government Legal General Politics Bupivacaine Hydrochloride Huons Co., Ltd.Medline FDA Product Recall Medical Devices Drug Safety Food Recalls Drugs
Total Nutrition Expands Recall of Moringa Capsules Over Salmonella Risk

12 Jun 2026 8:32 a.m. · Source: US Food and Drug Administration

Total Nutrition expanded its recall of TNVitamins and Doctor’s Pride Moringa Capsules due to *Salmonella* contamination. The dietary supplements, sold online, pose serious health risks, especially to vulnerable populations. Customers should dispose of products and seek refunds.

Health Business Medical Science Legal Education Social Issues Product Recall Salmonella Dietary Supplements Total Nutrition Moringa Capsules FDA Health Risk Food Recalls Drugs
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