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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
TeDan Surgical Innovations LLC
Lot Codes / Batch Numbers
Lot: 0619
Products Sold
Lot: 0619
TeDan Surgical Innovations LLC is recalling Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product U due to There was incorrect raw material used in the production of the identified lot.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There was incorrect raw material used in the production of the identified lot.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026