TeDan Surgical Innovations LLC: Medical Device Recall in 2020 - (Recall #: Z-1845-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 16, 2019

Date Posted: May 13, 2020

Recall Number: Z-1845-2020

Event ID: 85360

Reason for Recall:

There was incorrect raw material used in the production of the identified lot.

Status: Terminated

Product Quantity: 2 units

Code Information:

Lot: 0619

Distribution Pattern:

US Nationwide distribution in the states of NJ.

Voluntary or Mandated:

Voluntary: Firm initiated