ProVu Single Use Video Stylet with ET Tube — Class I medical device recall Z-0497-2021
Terminated recall by Flexicare Medical Ltd., reported 2020-12-02, distributed nationwide. When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the
| Recall number | Z-0497-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flexicare Medical Ltd., Rhondda Cynon Taff, N/A, United Kingdom |
| Recall initiated | 2020-09-22 |
| Classified | 2020-11-26 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2024-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 2,087 |
| Reason classes | device malfunction |
| Lot numbers | 038-990-065U, 038-990-070U, 038-990-075U, 038-990-080U, 191102900, 191102901, 191201567, 200100157, 200300486, 200300535, 200300536, 200300537, 200300539, 200402330, 200402331, 200402333, 200402334, 200402335, 200402336, 200402337, 200403976, 200404287, 200500068, 200500069, 200500991, 200500992, 200501790, 200803210, 200904316, 200904319, 201000808, 201000813, 201100558, 202002462 |
Product
ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers
Reason for recall
When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.
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-0497-2021. 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.