Takumi brand frozen tuna ground meat, raw but ready to eat, vacuum packaged units in…
Tokai Denpun USA Inc recalled this product and the FDA reported the enforcement action on 22 November 2023 as Class II. The recall was initiated by the firm. Histamine, high total plate count, coliforms, and E.coli (serotype is unknown).
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Takumi brand frozen tuna ground meat, raw but ready to eat, vacuum packaged units in fiber boxes, net wt. 11 lbs. per box. individual units were sold by weight at the point of sale. Product of Fiji, and imported by Tokai Denpun USA INC. Bellevue, WA. Vacuum package label is read in parts: Product of Fiji - Frozen Tuna Ground Meat, Keep Frozen.
- Reason for recall
- Histamine, high total plate count, coliforms, and E.coli (serotype is unknown).
- Recalling firm
- Tokai Denpun USA Inc
- Firm location
- Redmond, Washington, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0409-2024
- Quantity
- 686 cases
- Distribution
- Distributed in CA, NC, NV, and TX between August 2021 and September 2021.
- Initiated
- 5 October 2021
- Reported by FDA
- 22 November 2023
- Terminated
- 16 November 2023
- Firm notified by
- Telephone
- Product codes
- No codes printed on master cases or on vacuum original packages. The firm assigned their internal warehouse inventory system lot code for ground tuna for the first shipment as W7032594. However, upon return, the cases were assigned a new lot code W7034335 to segregate it away from the rest of the shipment in the warehouse inventory system. The second shipment internal lot code for the ground tuna is W7034472.
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 2.1 years, from 5 October 2021 to termination on 16 November 2023. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The distribution pattern names 2 states, and the FDA published the enforcement report 2.1 years after the firm began the recall.
- Recalls of fish or seafood run a median of 5 months, so this one was longer than usual for its category. Fish and fishery products are the one food category with their own HACCP regulation in the United States, 21 CFR part 123, because the hazards are species-specific: histamine in scombroid fish, ciguatera in reef fish, and Listeria in cold-smoked products.
Named in the distribution pattern: North Carolina, Nevada. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
What this recall was for
Chemical contamination
A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.
A preventive controls plan covers chemical contamination under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.35(b)
- Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
- 21 CFR 117.130(b)(1)(ii)
- Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.
E. coli
Shiga toxin-producing E. coli recalls concentrate in foods eaten raw or lightly cooked, where no step in the process is hot enough or long enough to be a kill step.
A preventive controls plan covers E. coli contamination under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.135(c)(1)
- Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
- 21 CFR 120
- Juice HACCP: the hazard analysis and critical control point system required for juice processors, including a treatment achieving a 5-log pathogen reduction.
Filed under fish and seafood and meat and poultry. A product can sit in more than one.
Other fish and seafood recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
All 2023 recalls · All FDA food recall data
21 CFR 117.35(b) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.