Food, drugs, devices › Given Imaging Ltd.
Food recall: Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose syrup, soy crisps, oats, pea protein,
FDA enforcement event 91620 is a food recall by Given Imaging Ltd. of Mansfield, MA, initiated 2 Feb 2023 and classified Class II, with 1 product record.
FDA defines Class II as 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. 53% of the 478 food enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 22 Mar 2024. Initiation: voluntary: firm initiated. Given Imaging Ltd. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Given Imaging Ltd., Mansfield, MA.
Reason for recall
"Cereal bar may be contaminated with tobacco beetles."
Distribution
"AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI; Australia, Canada, New Zealand, Sweden,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-0418-2023 | Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose syrup, soy crisps, oats, pea protein, puffed wheat (wheat, sugar), concentrated pineapple juice, fructose, dried cranberries (cranberries, sugar, sunflower oil), dried apples, brown sugar, invert sugar, glycerin, honey, potassium… | 2,665 units | Class II | Terminated | 15 Mar 2023 |
Context
Other enforcement events for Given Imaging Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Aug 2026 | Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Num | Device | Class I | 1 |
| 3 Jun 2025 | Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic | Device | Class I | 1 |
All 3 events for Given Imaging Ltd.
Questions and answers
Why was this food recalled?
FDA's record gives the reason for recall as: "Cereal bar may be contaminated with tobacco beetles."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI; Australia, Canada, New Zealand, Sweden,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Mar 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA food enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.