Capso Vision Recalls CapsoCAM Plus Capsule Endoscopy Systems
Capso Vision is recalling 1,882 CapsoCAM Plus capsule endoscopy systems because a defect in the capsule window may cause the housing to crack and leak during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (device failure and need for repeat exam) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Capso Vision, Inc. is recalling 1,882 units of the CapsoCAM Plus capsule endoscopy system (UDI: 00867770000209). The recall was initiated due to a defect in the capsule window that may be stressed during the production process and final packaging. This defect could cause the capsule housing to crack and leak when ingested by a patient.
If the capsule leaks, fluid from the patient may enter the device, potentially damaging internal components. This damage may prevent the retrieval of patient data, which could require the patient to repeat the endoscopic exam. The affected units were distributed in the United States (CA, TX, FL, VA, PA, SC, HI, DC, NJ, UT, LA) and in foreign countries including France, Argentina, Italy, the United Kingdom, Belgium, Turkey, Australia, Colombia, Gambia, Greece, Spain, Slovenia, Croatia, Morocco, and Sweden.
Healthcare providers and patients should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a unit is affected, it should be removed from service and returned to Capso Vision, Inc. according to the instructions provided by the manufacturer.
The recalled product
- Product
- CapsoCAM Plus, UDI: 00867770000209
- Manufacturer
- Capso Vision, Inc.
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 1,882
Distribution
Related recalls
Same manufacturer · Capso Vision, Inc.
See all →- ModerateCapso Vision Recalls CapsoCam Plus Capsules Due to Data Recording Failure
FDA (Devices) · 2020-07-15
- ModerateCapso Vision Recalls CapsoCam Plus Capsule Endoscopy Systems Due to Labeling Errors
FDA (Devices) · 2020-05-27
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12