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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

BritePro Solo Laryngoscope Handles Recalled for Failure to Illuminate

Agency Publication Date: August 1, 2025
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Summary

Flexicare Medical (Dongguan) Ltd. is recalling BritePro Solo Single-Use Fiber Optic Laryngoscope Handles and Blade combinations because the handles may fail to light up as intended. These medical devices are used by clinicians to visualize a patient's airway during intubation procedures. The recall affects multiple handle types, including Mini, Stubby, and Standard models, manufactured between July and December 2020. If the device fails to illuminate during use, it could delay a patient's treatment and lead to serious respiratory complications.

Risk

The failure of the laryngoscope handle to illuminate prevents healthcare providers from clearly seeing the patient's airway during intubation. This defect can lead to significant delays in securing an airway, potentially resulting in patient injury or death in emergency situations.

What You Should Do

  1. This recall affects BritePro Solo Single-Use Fiber Optic Laryngoscope Handles and Blade combinations with lot numbers ranging from 2007xxxxx to 2012xxxxx, produced between July 2020 and December 2020.
  2. Check your inventory for product REF numbers including 040-02-0110U through 040-02-0430U, 040-331U through 040-362U, 040-03-0000U, 040-309U, and 040-310U. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to ensure it is not used during patient care.
  4. Contact Flexicare Medical (Dongguan) Ltd. or your medical equipment distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) if you have questions regarding this safety alert.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BritePro Solo Single-Use Fiber Optic Mini Handle and Blade
Variants: Mac 1, Mac 2, Mac 3, Mac 3 Strong Curve, Mac 4, Miller 00, Miller 1, Miller 2, Miller 3
Model / REF:
040-02-0110U
040-02-0120U
040-02-0130U
040-02-0131U
040-02-0140U
040-02-0400U
040-02-0410U
040-02-0420U
040-02-0430U
Lot Numbers:
2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Date Ranges: Manufactured July 2020 to December 2020

Recall #: Z-2182-2025

Product: BritePro Solo Single-Use Fiber Optic Handle and Blade
Variants: Mac 1, Mac 2, Mac 3, Mac 3.5, Mac 4, Miller 1, Miller 2, Miller 3, Miller 4, Phillips 1, Phillips 2
Model / REF:
040-331U
040-332U
040-333U
040-335U
040-334U
040-341U
040-342U
040-343U
040-344U
040-361U
040-362U
Lot Numbers:
2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Date Ranges: Manufactured July 2020 to December 2020

Recall #: Z-2183-2025

Product: BritePro Solo Mini with Pro Miller Blade Size 1.5
Model / REF:
040-02-0415U
Lot Numbers:
2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Date Ranges: Manufactured July 2020 to December 2020

Recall #: Z-2184-2025

Product: Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle
Model / REF:
040-03-0000U
Lot Numbers:
2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Date Ranges: Manufactured July 2020 to December 2020

Recall #: Z-2185-2025

Product: BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle
Model / REF:
040-309U
Lot Numbers:
2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Date Ranges: Manufactured July 2020 to December 2020

Recall #: Z-2186-2025

Product: BritePro Solo Single-Use Fiber Optic Laryngoscope Handle
Model / REF:
040-310AU
040-310U
Lot Numbers:
2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Date Ranges: Manufactured July 2020 to December 2020

Recall #: Z-2187-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97139
Status: Active
Manufacturer: Flexicare Medical (Dongguan) Ltd.
Sold By: Hospitals; Surgical Centers; Medical Supply Distributors
Manufactured In: China
Distributed To: Washington, South Dakota, Texas, Virginia, Pennsylvania, Oklahoma, Georgia, Michigan, Wyoming, North Carolina, Ohio

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.