Fukushima suction tubes — Class II medical device recall Z-1845-2020
Terminated recall by TeDan Surgical Innovations LLC, reported 2020-05-13, distributed nationwide. There was incorrect raw material used in the production of the identified lot.
| Recall number | Z-1845-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TeDan Surgical Innovations LLC, Sugar Land, TX, United States |
| Recall initiated | 2019-07-16 |
| Classified | 2020-05-01 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2021-09-14 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| Lot numbers | 0619 |
| Model numbers | TK-1110 |
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.
Reason for recall
There was incorrect raw material used in the production of the identified lot.
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-1845-2020. 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.