FDAOctober 18, 2019device
CapsoCAM Plus, UDI: 00867770000209
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.
What to do
FDA enforcement status: Terminated
Brands named
capso visioncapso
UPCs
00867770000209
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAEverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH2022025-08-18
- FDACorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m2025-08-18
- FDAACUVUE¿ OASYS MAX 1-Day MULTIFOCAL2025-06-12
- FDACorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only2024-10-16
- FDAJohnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.2024-03-14
- FDATECNIS Toric II OptiBlue IOL Models ZCW2023-12-12
- FDATECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only2023-07-06
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