Mansfield, MA, United States
Given Imaging Ltd. recalls
3 recalls recorded since 2018, most recently on 6 August 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 6 August 2026
- Reason
- Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Czech Republic, Dominican Republic, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Kazakhstan, Kenya, Luxembourg, Netherlan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3090-2026
- Bravo 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.
Ongoing Class I Medical devices
- Recall started
- 3 June 2025
- Reason
- It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2047-2025
- Bravo 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)
Terminated Class II Food
- Recall started
- 2 February 2023
- Terminated
- 22 March 2024
- Reason
- 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, Switzerland, Taiwan, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.