Class II — TeDan Surgical Innovations LLC
| Recalling firm | TEDAN SURGICAL INNOVATIONS, INC. |
|---|---|
| Registered facility | TEDAN SURGICAL INNOVATIONS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There was incorrect raw material used in the production of the identified lot. |
| Product | Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field. |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the states of NJ. |
| Initiated | 2019-07-16 |
| Classified | 2020-05-01 |
| Terminated | 2021-09-14 |
| Recall number | Z-1845-2020 |
| 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 — TeDan Surgical Innovations LLC (Z-1845-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85360/
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