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Recall

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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 – Medline Updates Instructions for Use for Homecare Beds.”

This recall involves updating instructions for using devices and does not involve removing them 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.

What to Do:
Customers have reported incidents of hand control pendants burning, overheating, melting, sparking, causing electrical shock, and catching on fire only for the Medline Basic Beds identified in the alert. Such incidents pose significant risks, including serious injury and death. The FDA is recommending affected beds be left unplugged from wall power unless adjustments that require electricity need to be made.

For Medline Basic Beds and Medlite Homecare Beds identified, only use accessories intended for use with Medline Homecare Beds.

On November 26, Medline sent all affected customers a letter recommending the following actions:

  • To mitigate risk during use, strictly adhere to usage guidelines and safety instructions provided with the product as well as the following instructions:
    • Do not operate bed above the specified weight limit.
    • Ensure none of the bed components are jammed.
    • Ensure that there is no obstruction to the movement of the bed.
    • Hang the pendant on headboard or footboard when not in use.
    • Do not store the pendant on mattress at any time, including while asleep.
    • Unplug the bed and call for service if any of the following occur:
      • Bed motors appear to be jammed, stalled, or malfunctioning;
      • The bed pendant controls aren’t working;
      • Pendant wiring is damaged;
      • Pendant becomes hot to the touch; and/or
      • Smoke, sparking, or other unsafe electrical conditions occur.
    • Only use Medline side rails and Medline accessories that are intended for use with Medline Homecare Beds. When using Medline side rails and Medline accessories, follow all applicable instructions for use.
    • Do not use non-Medline side rails or non-Medline accessories, including extension cords, with Medline Homecare Beds. The following Medline Side Rail SKUs are compatible with both the Basic Homecare Beds and the Medlite Homecare Beds:
      • MDS89697 (Clamp-On Half Rail)
      • MDS89698N (Spring Loaded Half Rail)
      • MDS89694N (Spring Loaded Full Rail)
      • MDS89695N (Economy Full Rail)

Reason for Correction:
Medline has identified electrical safety risks with its Medline Basic Homecare Beds that may lead to fire.

The electrical safety risk is a potential hazard involving the hand control pendant and associated wires for Medline Basic Homecare Beds, SKUs MDR107002E, MDR107002E-4, MDR107003E, MDR107003E-4, and MDR107003ELO. In certain scenarios — such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor, among other potential conditions — the hand pendant and pendant cords may overheat and, in some instances, pose a risk of fire. Medline Industries has received reports of pendants sparking, burning, melting, smoking, and catching on fire.

As of December 18, Medline has reported 12 injuries and one death associated with this issue.

Additionally, Medline has identified patient entrapment as a potential issue when using non-Medline accessories on Medline beds. Non-Medline accessories or a user error when handling the pendant can unintentionally cause the bed to adjust position, entrapping the user’s body between the bed and the accessory. Entrapment could lead to asphyxiation, serious injury, and death. Patients with reduced monitoring, such as those at home, are at increased risk due to delays in detecting and responding to entrapment incidents.

As of December 18, Medline has reported two injuries and one death associated with the use of non-Medline approved accessories.

Device Use:
An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. Hospital beds include side rails that can be latched on or off and moved around.

Contact Information:
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medline Industries at 866-359-1704 or via email.

For additional information and specific models affected, visit the FDA’s website.

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Dexcom Issues Correction for Dexcom G6 and G6 Pro Software:

This recall involves correcting devices and does not involve removing the 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 correction.

Affected Product

  • Product Name: Dexcom G6 Continuous Glucose Monitoring System G6 and G6 Pro Android US CGM App, Version 1.15.0
  • This correction only affects users of v.1.15.0 of the Android US App and does not apply to other users. All affected devices have been updated to resolve this issue.
  • Unique Device Identifier (UDI): SW11678: 00386270000811

What to Do
Upgrade from app version 1.15.0 as soon as possible.

On September 18, Dexcom Inc. sent all affected customers an Urgent Medical Device Correction message recommending the following actions:

  • Upgrade from app version 1.15.0 as soon as possible.
    • Open App Store and search for Dexcom G6 app.
    • Install latest Dexcom G6 app version.
    • Open Dexcom G6 app.
  • Contact Technical Support at 1-844-478-1600 for further assistance.
  • Users will no longer be able to use app version 1.15.0 after October 6, 2025.

Reason for Correction
Dexcom Inc. is correcting the Dexcom G6 Continuous Glucose Monitoring System’s G6 and G6 Pro Android US CGM App version 1.15.0 due to an identified bug that can cause the app to terminate unexpectedly. As a result, the user may not receive estimated glucose values, alarms, or alerts. If a user is unaware that the app has terminated, there is potential for missed detection of a high blood sugar (hyperglycemic) or low blood sugar (hypoglycemic) event.

The use of affected product may cause serious adverse health consequences, including hyperglycemia, hypoglycemia, and death.

As of September 16, Dexcom has not reported any serious injuries or deaths associated with this issue.

Device Use
The Dexcom G6 Continuous Glucose Monitoring System is a real-time continuous glucose monitoring system that sends glucose readings to a compatible smart device or the Dexcom receiver every five minutes. The Dexcom G6 and G6 Pro Android US CGM App is an application for compatible smart devices that displays glucose levels and trends.

Contact Information
Customers in the U.S. with questions about this recall should contact Dexcom Technical Support at 1-844-478-1600.

Additional FDA Resources

Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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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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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) has shared this important announcement from the U.S. Food and Drug Administration (FDA) about a recall of two cough medicine products by Robitussin. The products are Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult. Please see the specific Lot Numbers below that are involved in the recall.  If you have one of these products with the matching Lot Number, stop use immediately and contact your health care provider.

Haleon Issues Voluntary Nationwide Recall of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products Due to Microbial Contamination

Summary
Company Announcement Date: January 24, 2024
FDA Publish Date: January 24, 2024
Product Type: Drugs
Reason for Announcement: Microbial Contamination
Company Name: Haleon
Brand Name: Robitussin
Product Description: Cough syrups

Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination.

In immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events, such as fungemia or disseminated fungal infection. In non-immunocompromised consumers, the population most likely to use the product, life-threatening infections are not likely to occur. However, the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out. To date, Haleon has not received any reports of adverse events related to this recall.

Robitussin Honey CF Max Day and Nighttime are cough syrups indicated for the temporary relief of symptoms occurring with cold or flu, hay fever, or other respiratory allergies. This recall covers only the following lots:

Product Lot Number Expiry Date
ROBITUSSIN HONEY CF MAX
DAY ADULT 4OZ		 T10810 31OCT2025
ROBITUSSIN HONEY CF MAX
DAY ADULT 8OZ		 T08730
T08731
T08732
T08733
T10808		 31MAY2025
31MAY2025
31MAY2025
31MAY2025
30SEP2025
ROBITUSSIN HONEY CF MAX
NT ADULT 8OZ		 T08740 T08742 30JUN2026
30JUN2026

Haleon is notifying its distributors and customers directly and has provided them with instructions for the return of all recalled products. Consumers that have purchased the product listed should stop consumption immediately. Please call our Consumer Relations team at +1-800-245-1040 (Monday through Friday 8:00 am – 6:00 pm Eastern Time) or reach out via email.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

  • Complete and submit the report online
  • Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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The Office of Developmental Programs (ODP) has shared important information about eye drops from the U.S. Food and Drug Administration. Eye drops from the 26 products listed here in the FDA MedWatch warning should not be used. CVS, Rite Aid, and Target are removing the products from their store shelves and websites. Products branded as Leader, Rugby, and Velocity may still be available to purchase in stores and online and should not be purchased.

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Draeger Medical, Inc. is recalling its Carina Ventilators due to the presence of contaminants in the device’s airpath. The contaminants exceed acceptable levels if used by pediatric patients for more than 30 days. During testing, the firm found polyether polyurethane (PE-PUR) in the airpath of the Carina ventilator. This results in the emission of contaminant 1,3-Dichloropropan-2-ol, a potential carcinogen.

Please be aware, this recall is a voluntary correction, not a product removal.

Clinicians may continue to use the devices with adult patients and are instructed to not use the devices with pediatric patients.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Read more here.

If you have questions about this recall, contact Draeger Service Technical Support between the hours of 8:00 am – 8:00 pm EST at 800-437-2437 (press 2 at the prompt, then 2 again).

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