Recall Register

Food, drugs, devices › Firms

Given Imaging Ltd.

FDA recalling firm · 3 enforcement events · 3 product records · 2023–2026 · MA, N/A

Given Imaging Ltd. has 3 FDA enforcement events on this register (3 product records) between 2023 and 2026: 2 device and 1 food; the busiest year was 2023 with 1.

67% of its events are Class I; the most common class is Class I (2). 2 events are listed as ongoing; the recalling firm's address is in MA and N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
6 Aug 2026Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.DeviceClass I1Ongoing
3 Jun 2025Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)DeviceClass I1Ongoing
2 Feb 2023Given 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…FoodClass II1Terminated

By type and class

Device2
Food1
Class I2
Class II1

Class I: 67% of this firm's events; 18% of all events on the register.

Events by year

23
24
25
26
Enforcement events for Given Imaging Ltd. by year initiated.

Questions and answers

How many FDA recalls has Given Imaging Ltd. had?

3 enforcement events (3 product records) on this register, 2023–2026: 2 device, 1 food.

Are any Given Imaging Ltd. recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Given Imaging Ltd. recalls?

2 Class I, 1 Class II. 67% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.