BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3 — Class II medical device recall Z-0803-2020
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-0803-2020 |
|---|---|
| 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 | 15055788724138 |
| Lot numbers | 040-333U, 170900328I, 180800461I, 180900072I, 180900104I, 181000107I, 181100013I, 181100097I, 181200024I |
| Model numbers | 040-333U |
Product
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.
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-0803-2020. 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.