The Recall Desk
ModerateFDA (Devices)·Z-2536-2020·Announced 2020-07-15

Capso Vision Recalls CapsoCam Plus Capsules Due to Data Recording Failure

Capso Vision is recalling 82 CapsoCam Plus capsules because they fail to record data when ingested, potentially delaying diagnosis.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a failure to record data, leading to delayed diagnosis and the need for repeat exams, but no physical injury or illness is reported.

Plain-English summary

Capso Vision, Inc. is recalling 82 units of the CapsoCam Plus (SV-3) wireless capsule endoscopy system. The affected devices are intended for the visualization of the small bowel mucosa in adults and may be used to detect abnormalities of the small bowel. The recall involves Lot number 01-19-0070, with specific serial numbers and Unique Device Identifiers (UDIs) listed in the official FDA record.

The recall was initiated because the capsules have an incorrect capture mode, which prevents them from recording data when ingested by patients. If these devices are used, there is a risk of delayed diagnosis, and patients may need to repeat the examination. The devices were distributed nationwide in the United States, including in the states of Arizona, California, Delaware, Maryland, New Jersey, New York, South Carolina, and Virginia.

Healthcare providers and patients should check their device serial numbers against the list provided in the FDA recall notice. If a device is affected, it should not be used for diagnostic purposes. Capso Vision, Inc. is the recalling firm responsible for this action.

The recalled product

Product
The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
Manufacturer
Capso Vision, Inc.
Category
Medical Device — Gastrointestinal Imaging
Hazard
Affected units
82

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI 010086777000020913200204172107011001-19-007021A00Y2K.700
  • S/N A00Z9J.700
  • UDI 010086777000020913200204172107011001-19-007021A00Z9J.700
  • S/N A011EP.700
  • UDI 010086777000020913200204172107011001-19-007021A011EP.700
  • S/N A011F3.700
  • UDI 010086777000020913200204172107011001-19-007021A011F3.700
  • S/N A013BM.700
  • UDI 010086777000020913200204172107011001-19-007021A013BM.700
  • S/N A013D8.700
  • UDI 010086777000020913200204172107011001-19-007021A013D8.700
  • S/N A013EH.700
  • UDI 010086777000020913200204172107011001-19-007021A013EH.700
  • S/N A013F9.700
  • UDI 010086777000020913200204172107011001-19-007021A013F9.700
  • S/N A013FP.700
  • UDI 010086777000020913200204172107011001-19-007021A013FP.700
  • S/N A014ZB.700
  • UDI 010086777000020913200204172107011001-19-007021A014ZB.700
  • S/N A01535.700

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

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