FDA announces recall on insulin pump pods after leaks cause 29 serious injuries

A recall on insulin pump pods has been designated by the U.S. Food and Drug Administration (FDA) as a Class I recall, the agency's most serious type after 29 serious injuries were reported.

To date, there have been no deaths associated with the defective devices, manufactured by Massachusetts-based Insulet. However, certain lots of the Omnipod 5—used in an automated insulin delivery system for those with Type 1 diabetes—will need to be removed from where they are used or sold in order to prevent any potential fatalities.

The insulin pump system, known for its invisible tubing unlike other wearable models on the market, uses a proprietary set of patches to administer insulin into the body as glucose levels change in diabetic patients throughout the day.
Omnipod 5, when functioning as intended, should correct insulin levels in the body every five minutes.

The issue with the recalled lot, according to Insulet which first announced the recall in a letter to known customers on March 12, stems from a manufacturing defect on the pods. Internal tubes within the devices that insulin flows through may contain small tears, leading to leaks that could cause an underdelivery of insulin.

As a result, patients may not receive the proper dose from the pump, leaving them with higher-than-expected blood sugar levels. This could lead to diabetic ketoacidosis, a potentially life-threatening condition that could cause patients to become delirious or unresponsive, putting others at risk if the patient is driving a car or operating heavy machinery.

Diabetic ketoacidosis requires immediate medical attention to mitigate.

Worse yet, the tears in the pods could cause the insulin pumps to enter a state of Automated Delivery Restriction, due to it not registering an underdose of insulin being delivered. This could happen without warning or alert, leaving the patient unaware that they received a lower-than-necessary dose of treatment.

While there is an alarm that is supposed to trigger if insulin enters the pod, that is reportedly not always happening.

The only solution, according to Insulet and the FDA, is to find a replacement for the defective pods. That starts with identifying those deemed defective.

What is being recalled?

The above image shows the packing for the Omnipod 5. The following is how the units with the potential leaky tears can be spotted.

• Unique Device Identifier: 10385083000527
• Click here for a full List of Affected Product

Next steps

Defective pods must not be used. If a patient does not have replacements, they should seek alternatives from their medical provider.

All products must be checked to see if they match the recall information above, including those currently being worn by patients.

In a letter sent to known Omnipod 5 customers in March, Insulet provided a form to return unused products and request replacements. Since that time, the list of defective units has been expanded to include those with expiration dates that have passed, so it’s important to check the above link for the full list of affected products.

Those with questions are advised to contact Insulet at 1-800-641-2049. The company said its service line is available 24 hours a day, seven days a week.

For more details, read the full FDA recall notice by clicking here.

More FDA Recalls:

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FDA announces recall on infusion systems after software anomaly injures 2 patients

FDA investigating outbreak of ‘extensively’ antibiotic resistant salmonella linked to supplement

FDA announces recall on insulin pump pods after leaks cause 29 serious injuries

Elon Musk Honey in the Morning

  

According to the FDA a reeent report from the FDA 

Emerging research suggests consuming one tablespoon of honey daily may act as a natural, neuroprotective strategy to prevent or slow dementia and Alzheimer’s progression. Rich in antioxidants and polyphenols, honey combats neuroinflammation and oxidative stress, with some studies showing significantly lower dementia incidence in users. 

Key Findings on Honey and Cognitive Health

• Preventive Potential: A 5-year study of 2,893 individuals aged 65+ in the Middle East found that 1 tablespoon of daily honey was associated with a roughly 80% lower incidence of developing dementia.
• Mechanisms of Action: Honey enhances the brain's cholinergic system, improves circulation, reduces amyloid-beta plaque accumulation, and decreases oxidative stress.
• Recommended Types: Studies indicate that specific regional honeys, particularly Tualang honey, Thyme honey, and Manuka honey, are high in polyphenols and neuroprotective properties.
• Limitations: Most evidence stems from animal studies (rats) or limited human pilot studies, with limited large-scale human clinical trials. 

Proposed Protocol (Based on Research Findings)

• Dosage: One tablespoon (roughly 20-30 grams) of raw, high-quality honey daily.
• Timing: Daily, consistently, for long-term preventive benefits.
• Considerations: While honey is natural, it is high in sugar, so individuals with diabetes or metabolic issues should consult a doctor. 

Disclaimer: Honey is a complementary approach for cognitive health, not a cure for dementia. It should be used alongside standard medical care. 

God news for bees, and beekers!!

Polyamine, a Hope for Spinal cord Injuries

 

She was told it was impossible.

For 30 years nobody funded her research. Nobody believed in what she was studying. She was a Brazilian biologist working alone on a question that the medical world had already given up on.

What if the spinal cord could heal itself?

Her name is Dr. Tatiana Coelho de Sampaio.

And she never stopped asking.

She discovered a protein called laminin. The same substance that guides our neurons as we grow in the womb. She figured out how to polymerize it. How to make it more powerful. How to inject it into a broken spinal cord and give damaged neurons a road to grow back on.

Paralyzed rats walked again.

Dogs with chronic spinal cord injuries regained movement.

Then came the human study.

Eight patients. Complete spinal cord injuries. A single injection within 72 hours of trauma.

Every single survivor regained voluntary motor control below the level of their lesion.

Every. Single. One.

I have spent decades in the operating room. I have sat with patients and families after the kind of injuries that change everything in an instant. I know what it feels like to deliver news that leaves no room for hope.

This leaves room for hope.

It is still experimental. Clinical trials are just beginning. Dr. Sampaio herself calls it a promise. Not yet a proven cure.

But this is how medicine changes forever.

Does polylaminin work?

Polymerized laminin promoted axonal regeneration and functional recovery in rats and dogs. Eight people treated with laminin demonstrated voluntary motor contraction. Brazil has authorized a phase 1 human study.Feb 26, 2026

Regeneration of spinal cord injury (SCI) is a major topic of biomedical research. Laminin is an extracellular matrix protein implicated in neural development and regeneration, but despite that, there are no reports of exogenous laminin contributing to improve the outcome of experimental SCI. Here we investigated whether a biomimetic polymer of laminin assembled on pH acidification, henceforth called polylaminin, could be used to treat SCI in rats. Acute local injection of polylaminin, but not of nonpolymerized laminin, improved motor function after thoracic compression, partial or complete transection. In the latter case, the BBB score for open field locomotion 8 wk after lesion increased from 4.2 ± 0.48 to 8.8 ± 1.14 in animals treated with polylaminin of human origin. Accordingly, neurons retrogradely labeled from the sublesion stump were detected in the spinal cord and brain stem, indicating regrowth of short and long fibers across a complete transection. Polylaminin also played an unsuspected anti-inflammatory role, which underlies the early onset of its positive effects on locomotion from the first week after treatment. The beneficial effects of polylaminin were not observed in animals treated with the nonpolymerized protein or vehicle only. We propose that polylaminin is a promising therapeutic agent to treat human SCI.

One person. One question. Thirty years of not giving up.

Save this. Share it with someone who needs to believe that what was broken can be rebuilt.

https://www.linkedin.com/posts/stefano-sinicropi_regenerativemedicine-spinalcordinjury-neuroscience-ugcPost-7452097955488153600-ikk9?utm_source=social_share_send&utm_medium=member_desktop_web&rcm=ACoAAAAqTbwBl7WHwBdULQ1iB1ThcCkr32EMVjE

Trump signs executive order to research psychedelics, including ibogaine, for mental health treatment - CBS News

President Trump has signed an executive order to ease research restrictions on psychedelics, including the drug ibogaine, which is used in some countries to treat post-traumatic stress disorder. 

Health officials, including Health and Human Services Secretary Robert F. Kennedy Jr., and podcaster Joe Rogan joined Mr. Trump in the Oval Office for the signing Saturday. 

Mr. Trump said the order will "dramatically accelerate access to new medical research and treatments based on psychedelic drugs," which he said have shown "life-changing potential." 

Mr. Trump said that the federal government will make a $50 million research investment into psychedelic research. He said the federal government was also opening a pathway for ibogaine to be administered to "desperately ill patients" under the Food and Drug Administration's Right To Try rule.  

"Everybody is so strongly in favor of this. It's for a lot of people, but it's for our veterans in particular," Mr. Trump said, highlighting veteran suicide rates. 

"If these turn out to be as good as people are saying it's going to have a tremendous impact on this country and in other countries too," Mr. Trump added. 

Food and Drug Administration commissioner Marty Makary said that three psychedelics would be added to the National Priority Voucher pilot program, which is a pathway meant to dramatically reduce review times for drug and biological products that align with U.S. national health priorities. The FDA will also begin the process to allow for researchers to conduct human trials into ibogaine's use, he said. 

"This is an unmet public health need and there are potentially promising treatments," Makary said. "That's why there is a sense of urgency around this."

CBS News first reported that Mr. Trump was expected to sign the order earlier this week. 

Ibogaine is a naturally occurring compound found in a shrub native to Africa. It has been used to treat depression, anxiety, addiction, post-traumatic stress disorder and brain trauma. Researchers say ibogaine could eventually fill a gap in addiction treatment, particularly for opioid dependence, but more large-scale clinical trials are needed before it can be considered safe or effective for any condition.

Former Surgeon General Jerome Adams, who served in Mr. Trump's first administration, said on "Face the Nation with Margaret Brennan" that early studies into ibogaine and other psychedelics have shown "potential for rapid improvements in symptoms and functioning in treatment-resistant cases" of people with mental health illnesses.

The order maintains full FDA and Drug Enforcement Administration oversight, Adams said, and does not legalize or reclassify psychedelics. 

The scientific evidence behind the drug so far consists mostly of small observational studies and open-label trials. Only one double-blind, placebo-controlled randomized clinical trial has been completed. More advanced trials have been started recently, and Texas Gov. Greg Abbott signed a bill approving $50 million for research last year. It is unclear how the federal government will help facilitate further research. Sources told CBS News that strategies were still being hammered out in internal discussions this week. 

As a Schedule I substance, ibogaine is currently grouped by the Drug Enforcement Administration alongside substances including heroin and ecstacy. Americans have traveled to unregulated clinics, often in Mexico or the Caribbean, to take the drug. Studies show that ibogaine can cause dangerous heart rhythm disturbances, which can be fatal. A 2023 review of 24 studies including 705 people called the risk of death from heart problems "worrying," and showed that at least 27 people have died after taking ibogaine.  

Trump signs executive order to research psychedelics, including ibogaine, for mental health treatment - CBS News