Given Imaging recalls
3 official recalls and safety alerts involving Given Imaging since 2023-03, from FDA · Device, FDA · Food. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Given Imaging or the relevant agency.
- 2026-09-16
USGiven Imaging Ltd. recalls Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used…
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,…
FDA · DeviceGiven Imaging Ltd.Worldwide distribution. US nationwide including Puerto Rico; Argentina,…Official notice →- 2025-07-16
- US
Given Imaging Ltd. recalls Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric…
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…
- 2023-03-15
- US
Given Imaging Ltd. recalls Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose syrup, soy crisps, oats, pea protein, puffed wheat…
Cereal bar may be contaminated with tobacco beetles.
FDA · FoodGiven Imaging Ltd.AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI,…Official notice →