Ocean Group Inc. recalled this product and the FDA reported the enforcement action on 27 June 2012 as Class II. The recall was initiated by the firm. Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shelf oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
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
Large IQF Oysters, 6 x 4 lb/cs
Reason for recall
Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shelf oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
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 is one of 3 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 3 separate recalls, which almost every published figure does, overstates it by a factor of 3. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 3 of them.
The recall ran for 3 months, from 2 June 2012 to termination on 6 September 2012. 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 FDA published the enforcement report 4 weeks after the firm began the recall.
Recalls of fish or seafood run a median of 5 months, so this one was shorter 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.
Filed under fish and seafood. A product can sit in more than one.
Other fish and seafood recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Undeclared Soy. Finished product ingredients statement declares Worcestershire sauce but does not declare sub-ingredients Soy Flavoring and Soy Lecithin.
Potential for contamination of Listeria monocytogenes. Environmental sample collected by FDA yielded positive results for one Zone 1 (cutting board) and one Zone 3 (floor drain).
Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Behind every recall is a clause 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.
Recall 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.
