BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2 — Class II medical device recall Z-0804-2020
Terminated recall by Flexicare Medical Ltd., reported 2020-01-22, distributed nationwide. The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade
| Recall number | Z-0804-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flexicare Medical Ltd., Rhondda Cynon Taff, United Kingdom |
| Recall initiated | 2019-11-27 |
| Classified | 2020-01-13 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2021-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CN, CZ, DK, FI, GB, IE, IT, KR, KW, LB, NL, PA, RO, RU |
| Quantity | 1,024,890 devices |
| UPC / GTIN / UDI-DI | 15055788724053 |
| Lot numbers | 040-342U, 180802596I, 181002320I, 181100085I, 181200025I |
| Model numbers | 040-342U |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0804-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.