Urgent Medical Device Recall: Getinge Vaporizers Pose Potential Health Risks

Urgent Medical Device Recall: Getinge Vaporizers Pose Potential Health Risks

Published: March 04, 2025
By: Garcia Family Medicine Team

At Garcia Family Medicine, we prioritize keeping our patients and community informed about important health and safety updates. Today, we’re sharing critical information about a recent medical device recall announced by the U.S. Food and Drug Administration (FDA) involving Getinge’s Vaporizer Sevoflurane Quick-Fil and Vaporizer Sevoflurane Maquet Filling. These devices, used in anesthesia systems, have been flagged for a serious issue that could affect both patients and healthcare providers.

What’s Happening?

Getinge, a medical equipment manufacturer, is recalling specific vaporizers used to deliver sevoflurane—a common anesthetic gas mixed with oxygen during surgeries. The FDA has classified this as a Class I recall, the most serious type, due to the potential for severe injury or even death. This recall expands on an earlier one from 2024, prompted by new concerns about the devices’ safety.

The problem stems from reports of discoloration and corrosion inside these vaporizers when used with certain brands of sevoflurane (produced by Piramal or Baxter). Over time, this sevoflurane can break down into hydrogen fluoride, a toxic chemical. If inhaled or touched, hydrogen fluoride could cause serious health issues, including:

• Respiratory irritation or fluid buildup in the lungs (lung edema)

• Skin blisters or wounds

• Dangerously low calcium or magnesium levels in the blood

• In extreme cases, death

Thankfully, no injuries or deaths have been reported so far, but the risks are significant enough to warrant immediate action.

Which Devices Are Affected?

The recall applies to the following vaporizers:

• Product Names: Vaporizer Sevoflurane Quick-Fil and Vaporizer Sevoflurane Maquet Filling

• Model Numbers:

  • Quick-Fil: 6682285

  • Maquet Filling: 6682282

• Serial Numbers:

  • Quick-Fil: All units with serial numbers above 3761

  • Maquet Filling: Units from 17336–23784 and all above 1339

These devices are part of Getinge’s Flow anesthesia systems, commonly used in hospitals and surgical centers to administer general anesthesia.

Why Does This Matter to You?

While this recall primarily affects healthcare facilities, it’s important for patients and families to be aware—especially if you or a loved one has recently undergone surgery or is scheduled for one. Anesthesia safety is critical, and issues like this could impact the quality of care provided. At Garcia Family Medicine, we believe informed patients are empowered patients.

What’s Being Done?

Getinge issued an Urgent Medical Device Recall letter on January 15, 2025, instructing healthcare providers to:

• Stop using affected vaporizers if they’ve been exposed to Piramal or Baxter sevoflurane.

• Quarantine any suspect devices.

• Avoid emptying vaporizers showing signs of discoloration, corrosion, or unusual odors—these should be handled with protective gear and stored safely.

• For unaffected units, empty the sevoflurane and run a “dry run” process to clear out any residue (detailed instructions were provided in the recall letter).

• Return affected devices to Getinge for replacement or further guidance.

Healthcare facilities are also asked to notify staff and other locations where these devices might have been transferred.

What Can You Do?

If you’re a patient:

• Ask your healthcare provider or surgeon about the equipment used during any recent or upcoming procedures.

• If you experience unusual symptoms after surgery—like breathing difficulties, skin irritation, or unexplained fatigue—contact your doctor immediately and mention this recall.

If you’re a healthcare professional:

• Check your inventory for the affected vaporizers and follow Getinge’s recall instructions.

• Report any issues to the FDA’s MedWatch program (details below).

How to Report Problems

The FDA encourages anyone—patients or providers—to report adverse reactions or device issues through MedWatch, their Safety Information and Adverse Event Reporting Program. You can file a report online at fda.gov/medwatch or call 1-800-FDA-1088.

Stay Informed

For more details, you can explore these FDA resources:

• FDA Enforcement Report

• Medical Device Recall Database

• Original 2024 Recall Notice

Questions about the recall? Contact Getinge’s Sales Support at CSalesSupport@getinge.com or reach out to your local Getinge representative.

Our Commitment to You

At Garcia Family Medicine, your health and safety are our top priorities. We’ll continue monitoring this situation and sharing updates as they become available. If you have concerns about this recall or any medical topic, feel free to reach out to our team—we’re here to help.

Stay safe and informed,
The Garcia Family Medicine Team

SinuCleanse Nasal Wash Recalled for Microbial Contamination: What You Need to Know

SinuCleanse Nasal Wash Recalled for Microbial Contamination: What You Need to Know

Published: March 03, 2025
By: Garcia Family Medicine Team

On February 25, 2025, Ascent Consumer Products Inc. announced a voluntary nationwide recall of one lot of its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System due to contamination with Staphylococcus aureus (S. aureus). At Garcia Family Medicine, we’re breaking down this recall and its potential risks to your health—especially if you rely on nasal irrigation for sinus relief.

The Recall

The affected product is the SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System, lot number 024122661A1 (exp. 12-31-2027), distributed nationwide in January 2025 through retail and online stores. This nasal wash, used to ease sinusitis, cold, flu, or allergy symptoms, was found contaminated after a confirmed test, prompting Ascent to pull it from the consumer market.

Health Risks

Using a contaminated nasal wash could be dangerous. S. aureus can cause blood infections if it enters through a compromised nasal lining, potentially leading to severe conditions like endocarditis (heart lining infection), meningitis, or bone and joint infections. It might also worsen sinusitis, risking eye damage or cranial nerve issues. While no adverse events have been reported yet, these risks are serious—something we take seriously in our practice.

What’s Happening Now

Ascent is contacting distributors and retailers via email to stop sales and remove the affected lot (check the carton side or saline packet back for 024122661A1). Consumers should stop using it immediately, return it to the purchase point, or discard it. Questions? Email Ascent at cs@ascentconsumerproducts.com (9am-5pm ET, Monday-Friday). Report issues to the FDA’s MedWatch program at www.fda.gov/medwatch/report.htm or 1-800-332-1088.

Our Support

Nasal irrigation can be a game-changer for sinus health, but safety comes first. If you’ve used this product or are worried about symptoms like unusual nasal irritation, contact Dr. Tess Garcia at +1 (816) 427-5320 or drtess@gmfdpc.com. We’re here to assess your risks and recommend safe alternatives tailored to your needs.

Stay proactive about your health,
Garcia Family Medicine Team

For more, visit us at garciafamilymedicine.care.

CAPS Recalls Phenylephrine IV Bags Due to Black Particulate Matter: What You Need to Know

CAPS Recalls Phenylephrine IV Bags Due to Black Particulate Matter: What You Need to Know

Published: March 03, 2025
By: Garcia Family Medicine Team

On February 24, 2025, Central Admixture Pharmacy Services (CAPS) announced a nationwide recall of three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL IV bags due to visible black particulate matter found in a supplier’s vial. At Garcia Family Medicine, we’re here to unpack this recall and its potential impact on your health.

The Recall

CAPS is pulling these IV bags (NDC: 71285-6092-1) from hospitals after their supplier detected contamination in a single sealed vial of Phenylephrine Hydrochloride. The affected lots—37-928390 (exp. 03MAR2025), 37-928796 (exp. 09MAR2025), and 37-928839 (exp. 10MAR2025)—were distributed across the U.S. between December 17, 2024, and January 8, 2025. This recall targets hospital-level use, not consumer products like vapes or oral medications.

Health Risks

Injecting a product with particulate matter could lead to serious issues. Locally, it might cause irritation or swelling. If particles enter the bloodstream, they could block vessels in the heart, lungs, or brain, potentially triggering strokes or even death. Thankfully, CAPS reports no adverse events so far, but the risk is real—something we monitor closely in our practice.

What’s Happening Now

CAPS is notifying hospitals and distributors via certified mail to arrange returns. The FDA is overseeing the recall, and consumers can report issues to the FDA’s MedWatch program (online at www.fda.gov/medwatch/report.htm or by calling 1-800-332-1088). If you’re a patient who’s received IV treatment recently, consult your healthcare provider about any concerns.

Our Support

At Garcia Family Medicine, we’re committed to your safety. If you or a loved one uses IV therapies—or if you’re worried about past treatments—contact Dr. Tess Garcia at +1 (816) 427-5320 or email drtess@gmfdpc.com. We can assess your situation and offer personalized guidance, especially for those with chronic conditions requiring IV medications.

Stay proactive about your health,
Garcia Family Medicine Team

For more, visit us at garciafamilymedicine.care.

FDA’s 2025 Push to Slash Nicotine in Cigarettes: What It Means for You

FDA’s 2025 Push to Slash Nicotine in Cigarettes: What It Means for You
Published: February 25, 2025
By Garcia Family Medicine Team

The FDA’s January 2025 proposal to cut nicotine in cigarettes to nonaddictive levels is gaining traction. At Garcia Family Medicine, we’re breaking down this potential shift—aimed at saving lives and curbing addiction—and what it means for your health.

The Proposal

The FDA wants to cap nicotine at 0.7 mg per gram in cigarettes, roll-your-own tobacco, most cigars, and pipe tobacco. This drastic reduction (from an average of 17.2 mg) targets combustible products—not vapes or smokeless tobacco—to break the addiction cycle.

Health Impact

Smoking kills nearly 500,000 Americans yearly, costing over $600 billion. The FDA predicts this rule could stop 48 million youth from starting by 2100 and help 19.5 million smokers quit within five years, slashing chronic diseases like cancer and heart disease we see in our practice.

Where It Stands

Public comments are open until September 15, 2025, via the Federal Register. If finalized, companies get two years to adjust. The incoming administration’s stance is unclear, but the health stakes are high.

Our Support

Quitting smoking is tough, but this could ease the path. At Garcia Family Medicine, we offer personalized plans to help. Call Dr. Tess Garcia at +1 (816) 427-5320 or email drtess@gmfdpc.com to start today.

Stay proactive about your health,
Garcia Family Medicine Team

For more, visit garciafamilymedicine.care.

Vitality Capsules Recalled Nationwide Due to Hidden Drug Risks

Vitality Capsules Recalled Nationwide Due to Hidden Drug Risks
Published: February 22, 2025
By Garcia Family Medicine

On February 20, 2025, One Source Nutrition, Inc. announced a voluntary nationwide recall of all lots of its Vitality Capsules, a male enhancement dietary supplement, after FDA testing revealed the presence of undeclared sildenafil and tadalafil—ingredients found in prescription erectile dysfunction drugs. At Garcia Family Medicine, we’re sharing this update to keep you informed about this serious health concern.

What Happened?

The FDA found that Vitality Capsules, marketed as a dietary supplement, contain sildenafil and tadalafil, both PDE-5 inhibitors used in FDA-approved medications like Viagra and Cialis. These substances aren’t allowed in dietary supplements, making Vitality an unapproved drug with untested safety and effectiveness. The recall, initiated by One Source Nutrition in Benton, Arkansas, affects all product lots distributed nationwide through retail outlets from a wholesale distributor. No adverse events have been reported yet, but the risk is significant enough to act swiftly.

Affected Product

The recalled Vitality Capsules come in a single-pill package with orange and gray coloring and blue text. Notably, the packaging lacks lot numbers or expiration dates. If you’ve purchased this product, identified as a male enhancement supplement, it’s part of this recall—whether from a store shelf or online.

Why It Matters

Using products with hidden sildenafil or tadalafil can be dangerous, especially if you take nitrates (common in medications for diabetes, high blood pressure, high cholesterol, or heart disease). These combinations can cause a steep drop in blood pressure, potentially leading to life-threatening consequences. Adult men, the primary users of this supplement, are most at risk—particularly those managing cardiac conditions with nitrate-based treatments.

Recommendations for Consumers

Here’s what you can do if you have Vitality Capsules:

• Check Your Supply: Look for the orange and gray single-pill package with blue writing.

• Stop Using It: Discontinue use immediately to avoid health risks.

• Return or Dispose: Return the product to where you bought it or discard it safely.

• Seek Medical Advice: If you’ve used it and feel unwell, contact Dr. Tess Garcia or call us at +1 (816) 427-5320 or drtess@gmfdpc.com.

Taking Action

One Source Nutrition is contacting distributors and customers via email to arrange returns. For questions, reach them at +1 (501) 778-3311 or onesourcelr@gmail.com , Monday through Friday, 10 AM to 6 PM CST. If you’ve experienced issues with this product, report them to the FDA’s MedWatch program online at fda.gov/medwatch/report.htm or by downloading a form at fda.gov/MedWatch/getforms.htm (call +1 (800) 332-1088) to request one, then fax to +1 (800) FDA-0178. This recall is overseen by the FDA, and we’ll keep you posted on any updates.

Your health matters to us at Garcia Family Medicine. Stay cautious with supplements, and lean on trusted sources for your wellness needs. Visit garciafamilymedicine.care for more health updates.

Stay safe and informed,
Garcia Family Medicine Team

For any concerns, contact us at garciafamilymedicine.care. Your health and safety are our priority.

Flu Cases Hit 15-Year High in the U.S.: Stay Safe This Season

Flu Cases Hit 15-Year High in the U.S.: Stay Safe This Season
Published: February 22, 2025
By Garcia Family Medicine

The U.S. is facing an unprecedented flu season, with the Centers for Disease Control and Prevention (CDC) reporting the highest number of cases in 15 years—levels not seen since the 2009 H1N1 swine flu outbreak. Even more striking, flu-related deaths have surpassed those from COVID-19 for the first time since the pandemic began in 2020. Here’s what’s happening and how you can protect yourself and your loved ones.

What Happened?

The CDC has flagged this flu season as exceptionally severe, with activity climbing steadily across the nation. As of the week ending February 1, 2025, over 48,000 people were hospitalized with influenza—a peak unmatched since the 2009 swine flu epidemic. Lab data shows 31% of flu tests came back positive, dwarfing last year’s peak of 18%. Meanwhile, 2% of U.S. deaths that week were linked to flu, outpacing the 1.5% tied to COVID-19. The CDC estimates this season has already seen 24 million illnesses, 310,000 hospitalizations, and 13,000 deaths, including 57 children. Experts attribute this surge to potent H1N1 and H3N2 strains, lower vaccination rates, and possibly co-infections with viruses like RSV.

Affected Populations

This flu season is hitting hard across all age groups, but children and older adults are especially vulnerable. The CDC notes that nearly 8% of healthcare visits in early February were for respiratory symptoms, a sharp rise from last year. Hospitals are packed, with emergency rooms and doctors’ offices overwhelmed by patients battling fever, coughs, and fatigue. Experts warn that unvaccinated individuals—particularly kids, where vaccination rates have dropped to 45% from 50% last year—face higher risks of severe outcomes.

The Severity of This Season

This year’s flu is intense but not entirely unexpected. “We’re seeing a tough influenza season nationwide,” says Dr. William Schaffner, an infectious disease expert at Vanderbilt University. “Hospitals are overflowing with patients feeling miserable, yet we don’t fully know why this season stands out.” Unlike 2009, no new strain has emerged—H1N1 and H3N2 are familiar culprits—but their strength, combined with declining immunity and vaccination gaps, may be driving the spike. Dr. Timothy Brewer from UCLA adds that while this season rivals 2009’s 60 million cases, it’s still within historical norms for bad flu years.

Recommendations for Staying Safe

Here’s how you can fight back against this flu surge:

• Get Vaccinated: The CDC urges everyone 6 months and older to get a flu shot—it’s not too late! Only 45% of adults and children are vaccinated this year, down from previous seasons, increasing risks for everyone.

• Watch for Symptoms: Look out for sudden fatigue, body aches, dry cough, sore throat, fever (100°F+), or nausea. If symptoms hit hard and fast, seek care quickly—don’t assume it’s just a cold.

• Protect Yourself and Others: Stay home if sick, avoid those showing signs of illness, wear a mask indoors, and wash your hands often. Simple steps like these can curb the spread.

• Seek Treatment: Antiviral drugs like Tamiflu can lessen flu severity if started early—call your doctor if you suspect flu. For questions, reach out to us at +1 (816)427-5320 or gigi@garciafamilymedicine.care.

Taking Action

Flu season runs October to May, peaking now in January and February due to cold weather and indoor gatherings. The CDC’s latest FluView report at cdc.gov/fluview tracks this ongoing wave—stay informed as numbers evolve. If you’re feeling ill or need guidance, don’t hesitate to act. Early care can make a difference, especially with flu outpacing COVID-19 in severity this year.

This season’s intensity reminds us how vital prevention is. Vaccination and basic precautions aren’t just about you—they protect your family and community too. For more tips, visit the CDC’s Flu Prevention page.

Stay safe and informed,
Garcia Family Medicine Team

For any concerns or questions about this flu season, feel free to contact us at garciafamilymedicine.care. Your health and safety are our priority.

FDA Extends Expiration Dates for OTC COVID-19 At-Home Tests: What You Need to Know

FDA Extends Expiration Dates for OTC COVID-19 At-Home Tests: What You Need to Know
Published: February 22, 2025
By Garcia Family Medicine

The U.S. Food and Drug Administration (FDA) has issued an important update regarding the Wondfo USA Co., Ltd. WELLlife COVID-19/Influenza A&B Home Test, extending the expiration dates for certain lots. This change ensures these tests remain reliable beyond their original shelf life, offering relief to households and healthcare providers alike as we navigate ongoing respiratory illness concerns.

What Happened?

The FDA, based on new stability data from Wondfo USA, has confirmed that specific lots of the WELLlife COVID-19/Influenza A&B Home Test can be used past their printed expiration dates without losing accuracy. Announced on February 22, 2025, this extension applies to tests already distributed across the U.S., giving consumers more time to use their kits effectively for detecting COVID-19 and influenza A and B.

Affected Products

This update covers the WELLlife COVID-19/Influenza A&B Home Test, an over-the-counter (OTC) product designed for at-home use with a nasal swab, delivering results in just 10 minutes. The extension applies only to certain lots—those with updated expiration dates based on manufacturer data. Not all kits are affected, so checking your specific lot is key.

The Importance of This Update

Accurate at-home testing is critical for managing respiratory illnesses like COVID-19 and flu. Extending expiration dates means fewer tests go to waste, ensuring you have a reliable tool on hand when symptoms strike. This is especially valuable during peak seasons, helping you catch infections early and reduce spread to family, friends, or coworkers.

Recommendations for Consumers

To make the most of this update:

• Check Your Test: Locate the lot number on your test kit, typically near the expiration date.

• Verify the Extension: Visit the FDA’s At-Home OTC COVID-19 Diagnostic Tests page or wondfousa.com to see if your lot qualifies for an extended date.

• Contact Support if Needed: For clarification, reach out to Wondfo at +1 (888) 444-3657 or support@welllifebio.com.

If your test is past its original date but not on the extended list, discard it safely and replace it to ensure accurate results.

Taking Action

If you have questions about your test or need help verifying its status, contact the FDA’s Division of Industry and Consumer Education or visit their website for assistance. Staying proactive keeps your testing reliable and your health protected.

This FDA update underscores the importance of staying informed about the tools we use to safeguard our well-being. By keeping your tests up to date, you’re better equipped to handle whatever this season brings.

For more health insights and updates, check out the CDC’s COVID-19 Testing page.

Stay safe and informed,
Garcia Family Medicine Team

For any concerns or questions about this update, feel free to contact us at garciafamilymedicine.care. Your health and safety are our priority.

FDA Issues Warning: Oysters from Louisiana Harvest Area 3 Contaminated with Norovirus

FDA Issues Warning: Oysters from Louisiana Harvest Area 3 Contaminated with Norovirus

Published: February 22, 2025
By Garcia Family Medicine

A recent FDA safety alert has raised concerns about the safety of oysters harvested from Louisiana Area 3, with a significant recall in place due to potential norovirus contamination. This warning extends to several states across the country, urging restaurants, retailers, and consumers to take immediate action.

What Happened?

The Louisiana Department of Health issued the recall after confirming that oysters harvested between January 10 and February 4, 2025, from Louisiana’s Area 3 have been linked to a norovirus outbreak. As investigations continue, it has been determined that these contaminated oysters were distributed not only within Louisiana but also to various other states, including Alabama, Florida, Maryland, Mississippi, North Carolina, Texas, and several others.

Affected Products

The recalled oysters include those sold for the half-shell market, shucked, frozen, breaded, and post-harvest processed oysters. These were sent to multiple distributors and retailers, and although the primary focus is on the above-mentioned states, they may have been distributed further. Consumers and food service establishments are urged to immediately discard any oysters harvested from Louisiana Area 3 between the specified dates.

The Danger of Norovirus

Norovirus is a highly contagious virus that can cause severe stomach and intestinal illness. The symptoms often include:

• Diarrhea

• Vomiting

• Nausea

• Stomach cramps

• Fever

• Headache

Symptoms typically appear 12 to 48 hours after exposure and can last 1 to 3 days. Dehydration is a major risk, especially for vulnerable groups like young children, older adults, and individuals with weakened immune systems. Signs of dehydration include dry mouth, dizziness, and decreased urination, and it’s crucial to seek medical attention if dehydration occurs.

Recommendations for Restaurants and Retailers

If your business has sold or served oysters from Louisiana Area 3 during the specified time frame, it is critical to act quickly. The FDA advises that these oysters not be served or sold. Restaurants and retailers should dispose of any potentially contaminated products immediately or arrange for their destruction with the distributor.

Additionally, businesses should ensure thorough cleaning and sanitizing practices, particularly for surfaces and utensils that came into contact with the oysters, to prevent cross-contamination. Employees should wash hands with warm water and soap after handling these products, and food preparation surfaces should be regularly sanitized.

Recommendations for Consumers

For consumers, the advice is clear: do not consume oysters from Louisiana Area 3 harvested between January 10 and February 4, 2025. If you experience any symptoms of norovirus after eating these oysters, seek medical attention promptly. Reporting your symptoms to your healthcare provider and the local health department can help authorities track and manage the outbreak.

Taking Action

If you suspect you've consumed contaminated oysters, or you wish to report an adverse event, contact the FDA at ShellfishEpi@fda.hhs.gov or visit the FDA's website for more assistance.

Norovirus outbreaks like these highlight the importance of food safety and proper hygiene practices in the kitchen. Restaurants, retailers, and consumers alike must stay vigilant to prevent illness and ensure public health.

Stay updated by following the FDA’s ongoing investigation, as they continue to monitor the situation and provide further alerts.

For further information on how to protect yourself from norovirus, visit the CDC's Norovirus Page.

Stay safe and informed,
Garcia Family Medicine Team

For any concerns or questions regarding this outbreak, feel free to contact us at Garcia Family Medicine. Your health and safety are our priority.