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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97139

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 11, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Flexicare Medical (Dongguan) Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3),

Z-2182-2025
Recall number
Z-2182-2025
Initiated
July 11, 2025
Classification
Class I
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Laryngoscope handles may not illuminate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Laryngoscope handles may not illuminate as intended.

Code information

Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

Distribution pattern

US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.

device · product 2 of 6

BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)

Z-2183-2025
Recall number
Z-2183-2025
Initiated
July 11, 2025
Classification
Class I
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Laryngoscope handles may not illuminate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Laryngoscope handles may not illuminate as intended.

Code information

Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

Distribution pattern

US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.

device · product 3 of 6

BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U

Z-2184-2025
Recall number
Z-2184-2025
Initiated
July 11, 2025
Classification
Class I
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Laryngoscope handles may not illuminate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Laryngoscope handles may not illuminate as intended.

Code information

Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

Distribution pattern

US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.

device · product 4 of 6

Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U

Z-2185-2025
Recall number
Z-2185-2025
Initiated
July 11, 2025
Classification
Class I
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Laryngoscope handles may not illuminate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Laryngoscope handles may not illuminate as intended.

Code information

Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

Distribution pattern

US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.

device · product 5 of 6

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

Z-2186-2025
Recall number
Z-2186-2025
Initiated
July 11, 2025
Classification
Class I
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Laryngoscope handles may not illuminate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Laryngoscope handles may not illuminate as intended.

Code information

Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

Distribution pattern

US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.

device · product 6 of 6

BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U

Z-2187-2025
Recall number
Z-2187-2025
Initiated
July 11, 2025
Classification
Class I
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Laryngoscope handles may not illuminate as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Laryngoscope handles may not illuminate as intended.

Code information

Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

Distribution pattern

US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.