Class II — WELL LEAD MEDICAL CO. LTD
| Recalling firm | Well Lead Medical (Hainan) Co., Ltd. |
|---|---|
| Registered facility | WELL LEAD MEDICAL (HAINAN) CO., LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The 6Fr suction catheter could not pass through the samples smoothly. |
| Product | SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25 |
| Quantity | 27200 |
| Distribution | US Nationwide distribution in the state of MI. |
| Initiated | 2026-07-31 |
| Classified | 2026-09-15 |
| Recall number | Z-3172-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — WELL LEAD MEDICAL CO. LTD (Z-3172-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99685/
Alerts for Well Lead Medical (Hainan) Co., Ltd.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.