Given Imaging Inc Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging system. The device is an ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging system. The device is an ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an
Brand
Given Imaging Inc
Lot Codes / Batch Numbers
GMB-0253-01-GLR Card-Proposed Diagnostic Algorithm for Suspected Crohn's Disease.
Products Sold
GMB-0253-01-GLR Card-Proposed Diagnostic Algorithm for Suspected Crohn's Disease.
Given Imaging Inc is recalling Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging system. The devi due to The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected Crohn's disease), w. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected Crohn's disease), were printed incorrectly.
Recommended Action
Per FDA guidance
Consignees were notified by letter on 12/13/2007. The letter contains a diagram illustrating the error on the incorrect card and a diagram illustrating the corrected card. Consignees were instructed to discard the incorrect card if they still have it and to complete a response form and return it via fax to Given Imaging.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026