Z-1845-2020Class II

Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 -

Name: Z-1845-2020 Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 -
Creator: TeDan Surgical Innovations LLC
Published: 2019-07-16
License: https://open.fda.gov/license/

Tedan Surgical Innovations, Inc. / initiated 2019-07-16 / Terminated / root cause: manufacturing process

FDA source

TeDan Surgical Innovations LLC began a recall of Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held... on 2019-07-16. FDA classified it as Class II and gives the reason as "There was incorrect raw material used in the production of the identified lot". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1845-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-16
Posted: 2020-05-01
Terminated: 2021-09-14
Recalling firm: Tedan Surgical Innovations, Inc.
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.
Product code: GEA Cannula, Surgical, General & Plastic Surgery
Reason for recall: There was incorrect raw material used in the production of the identified lot.
Root cause tag: manufacturing process
FDA 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: [email protected] or at 713-726-0886.
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the states of NJ.
Product codes and lots: Lot: 0619

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1845-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1845-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-01

Product code GEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)