TeDan Recalls Fukushima Suction Tubes Due to Incorrect Raw Material
TeDan Surgical Innovations LLC is recalling Fukushima suction tubes because incorrect raw material was used in production. The affected units were distributed in New Jersey.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is limited to incorrect raw material without specified acute risk, fitting the Moderate criteria for low-risk or precautionary issues.
Plain-English summary
TeDan Surgical Innovations LLC is recalling Fukushima suction tubes, specifically the Fukushima Malleable Tapered Suction, 3 FR, 145 MM (REF: TK-1110). These are nonpowered, hand-held reusable manual surgical instruments intended for general surgical procedures to remove debris and blood from the surgical field.
The recall was initiated because incorrect raw material was used in the production of the identified lot. The affected lot number is 0619, and the quantity involved is 2 units. The products were distributed nationwide in the United States, specifically within the state of New Jersey.
Healthcare facilities and consumers who have these specific units should stop using them and contact TeDan Surgical Innovations LLC for instructions on return or replacement. The FDA has classified this recall as Class II, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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…
- Manufacturer
- TeDan Surgical Innovations LLC
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 0619
Distribution
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