Class IITerminated · reported 2024-08-07

Jeni's Ice Cream Sandwiches Triple Berry Tart 3.5 fl oz UPC 858241006851.

Totally Cool, Inc. recalled this product and the FDA reported the enforcement action on 7 August 2024 as Class II. The recall was initiated by the firm. Possible contamination with Listeria monocytogenes

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
Jeni's Ice Cream Sandwiches Triple Berry Tart 3.5 fl oz UPC 858241006851. Individually wrapped in plastic and packaged in cardboard box, 3 sandwiches per box. 8 boxes per case.
UPC
858241006851
Reason for recall
Possible contamination with Listeria monocytogenes
Recalling firm
Totally Cool, Inc.
Firm location
Owings Mills, Maryland, United States
Classification
Class II
Status
Terminated
Recall number
F-1563-2024
Quantity
17837 cases
Distribution
Distributed nationwide.
Initiated
13 June 2024
Reported by FDA
7 August 2024
Terminated
8 October 2024
Firm notified by
E-Mail
Product codes
All Best by Dates: 07/24/25 to 05/23/2026 All Codes Between: 23205 to 24144 Plant Code: 2465

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 is one of 68 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 68 separate recalls, which almost every published figure does, overstates it by a factor of 68. 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 68 of them.
  • The recall ran for 4 months, from 13 June 2024 to termination on 8 October 2024. 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 8 weeks after the firm began the recall.
  • Recalls of ice cream or frozen dessert run a median of 7 months, so this one was shorter than usual for its category. Ice cream and frozen desserts are ready to eat and never cooked again, and freezing preserves Listeria rather than killing it, which is why a positive environmental sample in a frozen dessert plant becomes a recall rather than a corrective action.

What this recall was for

Listeria monocytogenes

Listeria monocytogenes is a bacterium that grows at refrigeration temperature, which is why it dominates recalls of ready-to-eat foods that are never cooked again before they are eaten.

A preventive controls plan covers Listeria 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)(3)
Sanitation controls: the controls on cleaning food-contact surfaces and on preventing cross-contact and cross-contamination from insanitary objects, people and equipment.
21 CFR 117.165(a)(3)
Environmental monitoring: testing the processing environment for an environmental pathogen, required when a ready-to-eat food is exposed to the environment before packaging.
21 CFR 117.150
Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.

Filed under ice cream and frozen desserts, milk and dairy, fresh produce and prepared meals and sandwiches. A product can sit in more than one.

Other ice cream and frozen desserts 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.

ReportedProductFirmReasonClass
2024-08-07Marco Turkish Mocha Ice Cream 16 fl oz/1 pint, UPC 860001992885. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Dolcezza Peanut Butter Stracciatella Gelato 16 fl oz/1 pint, UPC 857838006090. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Marco Dulce De Leche & Cookies Ice Cream 16 fl oz/1 pint, UPC 860006880514. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Dolcezza Stracciatella Gelato 16 fl oz/1 pint, UPC 857838006120. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Dolcezza Sugar Cookie Dough Gelato 16 fl oz/1 pint, UPC 857838006618. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Chipwich Vanilla Chocolate Chip Ice Cream Sandwich 4 fl oz sold as 3-pack, 10-pack, and 24 (single serve) pack. Sandwiches individually wrapped in plastic. Product packaged in cardboard boxes. UPCs 810493034013, 810493035010, and 810493030022. 12 boxes/8 boxes/24 boxes per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07The Frozen Farmer Santa's Cookies Ice Cream Cookie Sandwich the Elf On the Shelf 4 fl oz UPC 850023398178. Individually wrapped in plastic, 4 sandwiches packaged in a cardboard box, 24 boxes per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07LaSalle Chocolate Ice Cream 16 fl oz/1 pint, UPC 671891374114. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II

Other records from Totally Cool, Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 67 other records name this firm.

ReportedProductFirmReasonClass
2024-08-07Marco Turkish Mocha Ice Cream 16 fl oz/1 pint, UPC 860001992885. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Dolcezza Peanut Butter Stracciatella Gelato 16 fl oz/1 pint, UPC 857838006090. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Marco Dulce De Leche & Cookies Ice Cream 16 fl oz/1 pint, UPC 860006880514. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Dolcezza Stracciatella Gelato 16 fl oz/1 pint, UPC 857838006120. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Dolcezza Sugar Cookie Dough Gelato 16 fl oz/1 pint, UPC 857838006618. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Chipwich Vanilla Chocolate Chip Ice Cream Sandwich 4 fl oz sold as 3-pack, 10-pack, and 24 (single serve) pack. Sandwiches individually wrapped in plastic. Product packaged in cardboard boxes. UPCs 810493034013, 810493035010, and 810493030022. 12 boxes/8 boxes/24 boxes per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07The Frozen Farmer Santa's Cookies Ice Cream Cookie Sandwich the Elf On the Shelf 4 fl oz UPC 850023398178. Individually wrapped in plastic, 4 sandwiches packaged in a cardboard box, 24 boxes per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07LaSalle Chocolate Ice Cream 16 fl oz/1 pint, UPC 671891374114. Packaged in paper containers, 8 containers per case.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Amafruit Superfruits from the Amazon Organic Acai packaged in 3 gallon plastic tubs, UPC 855738002181.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II
2024-08-07Amafruit Superfruits from the Amazon Dragon Fruit. Packaged in 3 gallon plastic tubs, UPC 855738002242.Totally Cool, Inc.Possible contamination with Listeria monocytogenesClass II

All 68 records for Totally Cool, Inc.

All 2024 recalls · All FDA food recall data

21 CFR 117.135(c)(3) 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 access

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.