FDA Medical Device Recalls (openFDA)
TeDan Surgical Innovations LLC: 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.
- Recall number
- Z-1845-2020
- Recalling firm
- TeDan Surgical Innovations LLC
- 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.
- Status
- Terminated
- Initiated
- 2019-07-16
- Posted
- not on file
- Terminated
- 2021-09-14
- Reason
- There was incorrect raw material used in the production of the identified lot.
- Root cause
- Mixed-up of materials/components
- Action
- The recalling firm contacted their customer on 7/16/19 by phone. There was a follow up letter, dated 10/2/19 sent to the consignee. The recalling firm instructed their customer to return the recalled product. For questions contact: dfishman@tedansurgical.com or at 713-726-0886.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of NJ.
- Lot, serial or model codes
- Lot: 0619
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEA
- Firm FEI
- 3005726885
- Firm city
- Sugar Land
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28