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FDA

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The Office of Developmental Programs (ODP) has shared this important announcement from the U. S. Food and Drug Administration (FDA).

The FDA is aware that Abbott Diabetes Care has sent all affected customers, distributors, and health care providers a letter regarding an issue with certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors providing incorrect low glucose readings. If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.

As of November 14, 2025, Abbott has reported 736 serious injuries and seven deaths associated with this issue.

Affected Product

  • FreeStyle Libre 3 Sensor
    • Model Numbers: 72081-01, 72080-01
    • Unique Device Identifiers (UDI-DI): 00357599818005, 00357599819002
  • FreeStyle Libre 3 Plus Sensor
    • Model Numbers: 78768-01, 78769-01
    • Unique Device Identifiers (UDI-DI): 00357599844011, 00357599843014
  • Download the full list of affected lots

What to Do:

Patients should verify if their sensors are impacted and immediately discontinue use and dispose of the affected sensor(s).

On November 24, 2025, Abbott Diabetes Care sent all affected customers a letter recommending the following actions:

  • For Patients:
    • Determine if your current or unused sensor(s) are affected by visiting FreeStyle Check and selecting “CONFIRM SENSOR SERIAL NUMBER.” You will need to locate your sensor serial number to determine if your sensor is affected.
      • If you are wearing a FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor, you can find the serial number in the app or reader. The serial number can also be found on the label on the bottom of the sensor applicator or carton. (If you are using a sensor with a connected insulin delivery device, please refer to the connected insulin delivery device user manual on how to locate the sensor serial number.)
    • If you are currently wearing or have a FreeStyle Libre 3 or FreeStyle Libre 3 Plus sensor that has been confirmed as potentially affected on FreeStyle Check or by a customer service representative, immediately discontinue use and dispose of the affected sensor(s).
    • You can request a replacement for any potentially affected sensor(s) on FreeStyle Check. Select “CONFIRM SENSOR SERIAL NUMBER” and enter a valid serial number. If your sensor is potentially impacted, you will be instructed to enter your contact information so a replacement product can be sent to you at no cost.
    • Use a blood glucose meter or the built-in meter in your FreeStyle Libre 3 Reader to make treatment decisions when your sensor readings don’t match your symptoms or expectations.

Visit the FDA’s website for additional information and instructions on how to locate the Sensor’s Serial Number.

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The Office of Developmental Programs (ODP) is sharing this important announcement from the PA Department of Health.

As of November 11, 2025, 15 infants with suspected or confirmed infant botulism were reported from 12 states: Arizona, California (2), Illinois (2), Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington. Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from mid-August to November 2025. All 15 infants were hospitalized and treated with BabyBIG®. No deaths were reported. Infants ranged in age from 16 to 157 days. State and local public health officials are interviewing caregivers about the foods infants were fed in the month before they got sick. All 15 (100%) reported feeding ByHeart Whole Nutrition infant formula. This investigation is ongoing, and additional cases may be identified.

All ByHeart Whole Nutrition Infant Formula products were recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks. The link to the recall can be found here.

According to the FDA, ByHeart Whole Nutrition Infant Formula makes up less than 1 percent of all infant formula sales in the United States. Given this small market share, recall of these products is unlikely to create shortage concerns of infant formula for parents and caregivers.

Summary:

  • On November 11, 2025, ByHeart, Inc. recalled all lots of ByHeart Whole Nutrition Infant Formula in response to the U.S. Food and Drug Administration’s (FDA’s) ongoing investigation into a recent outbreak of infant botulism.
  • According to the company’s website, ByHeart Whole Nutrition Infant Formula was sold through its website ByHeart.com and through retail stores nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, SamsClub, and others.
  • Infant botulism is a rare but potentially fatal paralytic illness that impacts babies less than one year old. Symptoms can include constipation, poor feeding, drooping eyelids, weak cry, and progressive muscle weakness.
  • Health care providers (HCP) should call the California Infant Botulism Treatment and Prevention Program (IBTPP) immediately at 510-231-7600 for consultation of suspected case. Consultation is available 24/7. Treatment with botulism immune globulin, BabyBIG®, obtained from California Department of Health, is recommended for all suspected cases of infant botulism.
  • Infant botulism is a reportable disease in PA; all suspected cases must be reported to the Pennsylvania Department of Health (DOH) at 1-877-PA-HEALTH or their local health department.

For More Information

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The Office of Developmental Programs (ODP) has shared this important announcement from the U. S. Food and Drug Administration (FDA).

FDA MedWatch — DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products by DermaRite Industries

DermaRite Industries is recalling the below products due to microbial contamination identified as Burkholderia cepacia.

Risk Statement:

Burkholderia cepacia complex (BCC) in these products may result in serious and life-threatening infections. The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals. In healthy individuals with minor skin lesions, the use of the product will more likely result in local infections, whereas in immunocompromised individuals the infection is more likely to spread into blood stream leading to life-threatening sepsis.

The recalled products were distributed nationwide in the United States and in Puerto Rico.

To date, DermaRite has not received any reports of adverse events related to this recall.

Background:

  • DermaKleen is an OTC Healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.
  • DermaSarra is an OTC External analgesic indicated for temporary relief of itching associated with minor skin irritations due to dry skin, insect bites, detergents, sunburn.
  • KleenFoam is an OTC Antimicrobial foam soap with aloe vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.
  • PeriGiene is an OTC Antiseptic cleanser indicated for use in the perineal area.

Recommendations:

  • Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
  • Consumers with questions regarding this recall can contact Mary Goldberg at 973-569-9000 x104 or via email.
  • DermaRite has notified its distributors and customers by email to immediately examine available inventory and destroy all affected products in accordance with each facility’s process.

For more information about this recall and specific product number, visit the FDA’s website.

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The Office of Developmental Programs (ODP) has shared an important announcement from the US Food and Drug Administration (FDA).

Manual Resuscitator Recall: SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter

SunMed Holdings, LLC is recalling this product due to a manufacturing issue where the B/V filter was assembled onto the patient port instead of the exhalation port. This incorrect configuration may result in a delay in therapy during emergency use.

The use of the affected product may cause serious adverse health consequences, including lack of oxygen to the body (hypoxia), build-up of carbon dioxide in the blood (hypercapnia), organ failure, and death.

There have been no reported injuries. There have been no reports of death.

Device Use

The manual resuscitator is used to provide emergency respiratory support to adult patients. It includes a face mask, bag reservoir, filter, manometer, and oxygen tubing, and is used during situations such as cardiac arrest or respiratory failure to manually deliver breaths.

Affected Product

  • Product Names: Adult Manual Resuscitator with Medium Adult Mask, Bag Reservoir, Filter, Manometer and 7 ft. Oxygen Tubing
  • Unique Device Identifier (UDI)/Model: Each: 10884389164822, Case: 40884389164823
  • Lot/Serial Numbers: 526782, 526790, 526796, 526797, 526798, 526800, 526802, 526804, 526805, 526806, 26807, 526808, 526809, 526810, 526814, 526815, 526816, 526811, 526817, 526818

What to Do  

  • Stop using and quarantine all affected product immediately.
  • Document quantity on hand and arrange to return or destroy affected units.

On May 1, 2025, SunMed Holdings, LLC sent all affected customers an Urgent Medical Device Recall notice recommending the following actions:

  • Check your inventory for the affected product.
  • Stop using the product immediately and quarantine it.
  • Document the amount of product on hand and return or destroy affected units.
  • Distribute the recall notice to any customers who received the product from you.
  • Complete and return the response form via email as soon as possible.
  • If you need urgent assistance or replacement, contact SunMed directly.
  • Notify all affected personnel in your organization of recall.

Refer to the FDA Original Press Release for instructions on requesting a replacement and additional information.

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The Office of Developmental Programs (ODP) has shared an important announcement from the U.S. Food and Drug Administration (FDA) regarding an expanded recall on the SmartDrive Speed Control Dial by Max Mobility/Permobil due to the motor being unresponsive to the user.

Summary:

  • Max Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device, due to safety and performance concerns.
  • This frame-mounted Speed Control Dial can be easily mounted to a wheelchair to allow for close access and easy pressing.
  • The recall was originally initiated on December 20, 2024, and has been expanded to address recalled products that may have been inadvertently comingled with redesigned product and shipped after December 20, 2024.
  • Those impacted by the expansion of the recall will be contacted with additional instructions.
  • This recall, as expanded, impacts all Speed Control Dials manufactured and distributed between the dates of August 17, 2023, through March 10, 2025.
  • As of March 27, 2025, Max Mobility/Permobil has received 781 complaints associated with the Speed Control Dial. As of March 27, 2025, five (5) serious injuries have been reported for this issue.
  • The reported serious injuries include a fractured hip, fractured tibia, fractured malleolus bone, broken ribs, and a concussion.

Background:

Max Mobility/Permobil Brand – (model number: MX2-3DCK/MX2-3DC): The frame-mounted Speed Control is easily mounted to a wheelchair to allow for close access and easy pressing. The Speed Control Dial can be used to deactivate the SmartDrive motor, as well as provide a means of actively powering the motor.

Recommendations:

To reduce the likelihood of a hazardous situation, discontinue use of the Speed Control Dial and utilize an alternate wired controller (Switch Control buttons or Switch Control with mono jack and mechanical switch) or wearable controller (compatible Apple Watch or Samsung Galaxy Watch Wear OS app).

If you have purchased a Speed Control Dial(s) with the above model numbers, you will need to request replacement Speed Control Dial units.

Refer to the FDA Original Press Release for instructions on requesting a replacement and additional information.

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Photo by Alena Shekhovtcova from Pexels

The FDA has approved and authorized for emergency use updated COVID-19 vaccines (2024-2025 formula) that include a monovalent (single) component that corresponds to the omicron variant KP.2 strain of SARS-CoV-2. These vaccines were updated to provide better protection against COVID-19 caused by circulating variants. Two vaccines are available for use in the United States: 2024–2025 Moderna COVID-19 Vaccine and 2024–2025 Pfizer-BioNTech COVID-19 Vaccine. There is no preference for one vaccine over the other when more than one vaccine is recommended for an age group

Who should get the vaccine?

Everyone ages 6 months and older should get the 2024–2025 COVID-19 vaccine. This includes people who have received a COVID-19 vaccine before and people who have had COVID-19. The COVID-19 vaccine helps protect you from severe disease, hospitalization, and death.

It is especially important to get your 2024–2025 COVID-19 vaccine if you are:

  • Ages 65 and older,
  • At high risk for severe COVID-19
  • Have never received a COVID-19 vaccine.
  • Are living in a long-term care facility
  • Are pregnant, breastfeeding, trying to get pregnant, or might become pregnant in the future.
  • Want to lower your risk of getting Long COVID

People who recently had COVID-19:

  • People who recently had COVID-19 may delay getting a COVID-19 vaccine for 3 months.
  • The risk of getting COVID-19 is less likely in the weeks to months following a SARS-CoV-2 infection.

Certain factors could be reasons to get a vaccine sooner rather than later, such as:

  • Personal risk of severe COVID-19
  • Risk of COVID-19 in a family or household member or other close contact
  • local levels of COVID-19 illness

Keep in mind‎:

  • Vaccine protection decreases over time, so it is important to stay up to date with your COVID-19 vaccine.
  • Getting a COVID-19 vaccine is a safer, more reliable way to build protection than getting sick with COVID-19.

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The Office of Developmental Programs (ODP) has shared this important announcement from the U.S. Food and Drug Administration (FDA) about the recall of Defibtech, LLC, RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions. The use of the affected product may cause serious adverse health consequences, including:

  • Patient injuries;
  • Delay of therapy; and
  • Death due to a period of time without compressions to circulate oxygen throughout the body.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Affected Product

  • RMU-2000 Chest Compression Module
    • Product Name: RMU-2000 ARM XR Chest Compression Device
    • Unique Device Identifier (UDI)/: UDI-DI: 00815098020812, 10815098020819
    • Serial Numbers: See full list.

What to Do

Do not use affected Defibtech RMU-2000 ARM XR Chest Compression Devices (identified by serial numbers). On July 12, 2024, Defibtech, LLC, sent all affected customers an Urgent Medical Device Safety Removal letter recommending the following actions:

  • Identify and quarantine affected units; and
  • If devices were transferred or distributed further, please ensure the recipients are aware of this notice or provide Defibtech with contact information.

Customers will be contacted by Defibtech to arrange for product return and devices will be refunded, repaired, or replaced at no cost.

Reason for Recall

Defibtech, LLC, is recalling RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions.

The use of affected product may cause serious adverse health consequences, including patient injuries, delay of therapy and death due to a period of time without compressions to circulate oxygen throughout the body. There has been one reported injury and one report of death.

Device Use

The RMU-2000 ARM XR Chest Compression Device is used to provide chest compressions on adults whose hearts suddenly stop and are not circulating blood throughout the body.

Contact Information

Customers in the US with questions about this recall should contact Defibtech Customer Support at 877-453-4507, 7:30 am – 6:00 pm EST.

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The Office of Developmental Programs (ODP) has shared an important announcement from the US Food and Drug Administration (FDA) about a recall of Clonazepam Orally Disintegrating Tablets due to mislabeling of the carton. This medication may be used in the treatment of Lennoz-Gastaut syndrome (petit mal variant), akinetic, myoclonic seizures, and panic disorders. Endo USA, Inc. is recalling USP (C-IV) Lot Number 550147301 due to the incorrect strength being on the product. If you have this product with the matching Lot Number, stop use immediately and contact your health care provider.

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The Office of Developmental Programs (ODP) is sharing an important announcement from the U.S. Food and Drug Administration (FDA) warning individuals of the 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 blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGM). The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own. If your medical care depends on accurate blood glucose measurements, talk to your health care provider about an appropriate FDA-authorized device for your needs.

View the FDA alert here.

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