Class IITerminated · reported 2022-09-14

Gourmet Junior Burger Roll 12-pack (033474501308)

Piantedosi Baking Co., Inc. recalled this product and the FDA reported the enforcement action on 14 September 2022 as Class II. The recall was initiated by the firm. Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum

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
Gourmet Junior Burger Roll 12-pack (033474501308)
Reason for recall
Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinum
Firm location
Malden, Massachusetts, United States
Classification
Class II
Status
Terminated
Recall number
F-1708-2022
Quantity
18,119 frozen product trays (total)
Distribution
MA, ME, NH, NY, VT, RI, CT, NJ, VA, FL, NC, SC, IL, MS, CO
Initiated
17 August 2022
Reported by FDA
14 September 2022
Terminated
29 December 2022
Firm notified by
E-Mail
Product codes
Lot Codes: 22083; 22104; 22112; 22115 Expiration: 3/24/2023; 4/14/2023; 4/22/2023; 4/25/2023

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 18 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 18 separate recalls, which almost every published figure does, overstates it by a factor of 18. 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 18 of them.
  • The recall ran for 4 months, from 17 August 2022 to termination on 29 December 2022. 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 15 states, and the FDA published the enforcement report 4 weeks after the firm began the recall.
  • Recalls of a bakery product run a median of 6 months, so this one was shorter than usual for its category. Bakery is overwhelmingly an allergen category rather than a pathogen one: baking is a kill step, but a bakery runs many recipes down shared lines, so the failure that recalls a bakery product is usually a label or a changeover.

Named in the distribution pattern: Massachusetts, Maine, New Hampshire, New York, Vermont, Rhode Island, Connecticut, New Jersey, Virginia, Florida, North Carolina, South Carolina, Illinois, Mississippi, Colorado. 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

Clostridium botulinum

Clostridium botulinum recalls are recalls of the process, not of a test result: the organism produces its toxin without oxygen, so a low-acid food in a sealed container that missed its scheduled process is recalled whether or not toxin was ever found.

A preventive controls plan covers a botulism risk 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 113
Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
21 CFR 108.35
Emergency permit control: the registration and process filing a low-acid canned food processor must hold before it may operate.

Filed under bakery. A product can sit in more than one.

Other bakery 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
2026-02-11Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Lemon Pie- UPC# 5061033691271Diva Fam Incpotential Clostridium botulinum contaminationClass II
2022-09-14Brioche-Style Slider Roll 24-pack (033474512021)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14Clustered Potato Burger Roll 12-pack (033474502855)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14King's Hawaiian 10.5 oz. Pretzel Hamburger Buns (UPC 73435000365), 10.2 oz. Pretzel Bites (UPC 73435000525.), and 11 oz. Slider Buns (UPC 73435000372 ) packed in plastic bags. Distributed by King s Hawaiian Bakery West, Inc., 19161 Harborgate Way, Torrance, CA 90501King's Hawaiian BakeryIngredient used to manufacture pretzel products may have been contaminated with Cronobacter sakazakii, and/or Clostridium botulinum.Class II
2022-09-14Gourmet Potato Deli Roll 12-pack (033474503647)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14Gourmet Burger Roll 12-pack (033474501322)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14SPR Roll 12-pack (033474501339)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14Split Top Burger Roll 12-pack (033474503777)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II

Other records from Piantedosi Baking Co., Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 17 other records name this firm.

ReportedProductFirmReasonClass
2022-09-14Brioche-Style Slider Roll 24-pack (033474512021)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14Clustered Potato Burger Roll 12-pack (033474502855)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14Gourmet Potato Deli Roll 12-pack (033474503647)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14Gourmet Burger Roll 12-pack (033474501322)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14SPR Roll 12-pack (033474501339)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14Split Top Burger Roll 12-pack (033474503777)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14B & W Gourmet Burger Roll 12-pack (033474504644)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14Soft Dinner Roll No Seeds Unsliced 24-pack (033474400960)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14B & W Sweet Burger Roll 12-pack (033474502947)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II
2022-09-14Slider Rolls No Seeds 24-pack (033474504941)Piantedosi Baking Co., Inc.Products may be contaminated with Cronobacter sakazakii and/or Clostridium botulinumClass II

All 18 records for Piantedosi Baking Co., Inc.

All 2022 recalls · All FDA food recall data

21 CFR 113 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.