Z-2186-2025Class I

BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U

Name: Z-2186-2025 BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
Creator: Flexicare Medical (Dongguan) Ltd.
Published: 2025-07-11
License: https://open.fda.gov/license/

Flexicare Medical (Dongguan) Ltd. / initiated 2025-07-11 / Open, Classified / root cause: manufacturing process

FDA source

Flexicare Medical (Dongguan) Ltd. began a recall of BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U on 2025-07-11. FDA classified it as Class I and gives the reason as "Laryngoscope handles may not illuminate as intended". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2186-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-07-11
Posted: 2025-08-01
Recalling firm: Flexicare Medical (Dongguan) Ltd.
Product: BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
Product code: CCW Laryngoscope, Rigid
Reason for recall: Laryngoscope handles may not illuminate as intended.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On July 11, 2025, Flexicare Medical Limited issued a Urgent: Medical Device Recall notification to affected consignees via E-Mail. Flexicare ask consignees to take the following actions: 1. Review Inventory for affected product and immediately quarantine. 2. All affected devices must be manually checked using the following procedure within customer notification. 3. All devices which demonstrate a failure to illuminate shall be withdrawn from use, quarantined, and returned. 4. If tested devices illuminate, they can continue to be used. Please ensure you subsequently continue to follow the Pre-Use Checks information as per the IFU. 5. Share this notice with any users of the product within your distribution network. 6. If your firm has further distributed the product, please provide them with the notification and inform them to notify their customers. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program . 8. In the event of light failure, the caregiver should revert to the local standard of care, including oxygenation, sourcing a functional laryngoscope, or relying on another method to provide patient ventilation.
Distribution: US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
Product codes and lots: Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2186-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2182-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-01
Z-2183-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-01
Z-2184-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-01
Z-2185-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-01
Z-2186-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-01
Z-2187-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-01

Product code CCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)