CLASS II Device recall · Reported 22 Jan 2020 · FDA Enforcement Report
BriteBlade Pro Single-Use Fiber Optic Handle recalled
Flexicare Medical is recalling BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, distributed nationwide in the US. The recall was initiated on 27 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0804-2020
- FDA event ID
- 84367
- Recalling firm
- Flexicare Medical, Rhondda Cynon Taff
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Nov 2019
- FDA classified
- 13 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 27 Nov 2019 | Recall initiated by company | |
| 13 Jan 2020 | Classified by FDA | +47 days |
| 22 Jan 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320
Where it was distributed
US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK
Questions about this recall
Is BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use recalled?
Yes. Flexicare Medical recalled BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use on 27 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-0804-2020.
Why was it recalled?
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
Which lots are affected?
Part Number/Lot Number: 040-342U 180802596 I OGH 040-342U 181002320 I OGH 040-342U 181100085 I OGH 040-342U 181200025 I OGH
Where was it sold?
US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Flexicare Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | ProVu Single Use Video Stylet with ET Tube, Part/Size recalled | Flexicare Medical | Other | Nationwide |
| Device | CLASS II | BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use recalled | Flexicare Medical | Sterility | Nationwide |
| Device | CLASS II | BriteBlade Pro Single-se Fiber Optic Miller 2, CE recalled | Flexicare Medical | Sterility | Nationwide |
| Device | CLASS II | BriteBlade Pro Single-Use Fiber Optic Handle recalled | Flexicare Medical | Sterility | Nationwide |
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