FDA Recalls Certain Dexcom Glucose Monitor Receivers
Recall
U.S. Food and Drug Administration Issues Product Recall Alert on Manual Resuscitator Devices
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.
FDA Recalls SmartDrive Speed Control Dial
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.
ODP Shares Chest Compression Device Recall
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.
Endo USA, Inc. Issues Recall of One Lot of Clonazepam Due to Mislabeling
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.
FDA Issues Recall of Cough Medicine
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.
ODP Shares FDA Recall of Contaminated Eye Drops
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.
FDA MedWatch: Draeger Recalls Carina Sub-Acute Care Ventilators for Contaminants in Airpath
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.
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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