FDA Device recall Z-1845-2020
Fukushima suction tubes
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of Fukushima suction tubes by Tedan Surgical Innovations, citing there was incorrect raw material used in the production of the identified lot.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1845-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-16 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Tedan Surgical Innovations |
| Distribution | US |
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
There was incorrect raw material used in the production of the identified lot.
Identifiers
| code_info | Lot: 0619 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1845-2020%22
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