CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is 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.

Class I - Dangerous

🏥 Medical Devices Recalled: July 3, 2019 Capso Vision Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
Lot Number: 02-18-0036 Serial Number and UDI Codes: A00ZD4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZD4.699; A00ZJ2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZJ2.699; A00ZK2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZK2.699; A00ZM0.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZM0.699; A00ZM3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZM3.699; A00ZN3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZN3.699; A00ZQ5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZQ5.699; A00ZW6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZW6.699; A01004.699 0100867770000209 13180921 17200921 1002-18-0036 21A01004.699; A0100H.699 0100867770000209 13180921 17200921 1002-18-0036 21A0100H.699; A0102J.699 0100867770000209 13180921 17200921 1002-18-0036 21A0102J.699; A0104G.699 0100867770000209 13180921 17200921 1002-18-0036 21A0104G.699; A0104U.699 0100867770000209 13180921 17200921 1002-18-0036 21A0104U.699; A00ZD6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZD6.699; A00ZJ5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZJ5.699; A00ZK4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZK4.699; A00ZX4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZX4.699; A010AA.699 0100867770000209 13180921 17200921 1002-18-0036 21A010AA.699; A00ZL7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL7.699; A00ZL8.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL8.699; A0102T.699 0100867770000209 13180921 17200921 1002-18-0036 21A0102T.699 A010A8.699 0100867770000209 13180921 17200921 1002-18-0036 21A010A8.699; A010TD.699 0100867770000209 13180921 17200921 1002-18-0036 21A010TD.699; A00ZY5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY5.699; A010QP.699 0100867770000209 13180921 17200921 1002-18-0036 21A010QP.699; A010T9.699 0100867770000209 13180921 17200921 1002-18-0036 21A010T9.699; A010UC.699 0100867770000209 13180921 17200921 1002-18-0036 21A010UC.699; A00ZL4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL4.699; A00ZN4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZN4.699; A00ZP5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZP5.699; A00ZQ4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZQ4.699; A00ZW9.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZW9.699; A00ZY1.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY1.699; A00ZY4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY4.699; A00ZY6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY6.699; A00ZZ7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZZ7.699; A010N1.699 0100867770000209 13180921 17200921 1002-18-0036 21A010N1.699; A00ZC7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC7.699; A00ZG3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZG3.699; A00ZX7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZX7.699; A010PH.699 0100867770000209 13180921 17200921 1002-18-0036 21A010PH.699; A00ZC2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC2.699; A00ZC6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC6.699; A00ZH4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZH4.699
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Capso Vision, Inc.
Reason for Recall:: Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is 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.

Product Codes/Lot Numbers:

Lot Number: 02-18-0036 Serial Number and UDI Codes: A00ZD4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZD4.699; A00ZJ2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZJ2.699; A00ZK2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZK2.699; A00ZM0.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZM0.699; A00ZM3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZM3.699; A00ZN3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZN3.699; A00ZQ5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZQ5.699; A00ZW6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZW6.699; A01004.699 0100867770000209 13180921 17200921 1002-18-0036 21A01004.699; A0100H.699 0100867770000209 13180921 17200921 1002-18-0036 21A0100H.699; A0102J.699 0100867770000209 13180921 17200921 1002-18-0036 21A0102J.699; A0104G.699 0100867770000209 13180921 17200921 1002-18-0036 21A0104G.699; A0104U.699 0100867770000209 13180921 17200921 1002-18-0036 21A0104U.699; A00ZD6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZD6.699; A00ZJ5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZJ5.699; A00ZK4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZK4.699; A00ZX4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZX4.699; A010AA.699 0100867770000209 13180921 17200921 1002-18-0036 21A010AA.699; A00ZL7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL7.699; A00ZL8.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL8.699; A0102T.699 0100867770000209 13180921 17200921 1002-18-0036 21A0102T.699 A010A8.699 0100867770000209 13180921 17200921 1002-18-0036 21A010A8.699; A010TD.699 0100867770000209 13180921 17200921 1002-18-0036 21A010TD.699; A00ZY5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY5.699; A010QP.699 0100867770000209 13180921 17200921 1002-18-0036 21A010QP.699; A010T9.699 0100867770000209 13180921 17200921 1002-18-0036 21A010T9.699; A010UC.699 0100867770000209 13180921 17200921 1002-18-0036 21A010UC.699; A00ZL4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZL4.699; A00ZN4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZN4.699; A00ZP5.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZP5.699; A00ZQ4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZQ4.699; A00ZW9.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZW9.699; A00ZY1.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY1.699; A00ZY4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY4.699; A00ZY6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZY6.699; A00ZZ7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZZ7.699; A010N1.699 0100867770000209 13180921 17200921 1002-18-0036 21A010N1.699; A00ZC7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC7.699; A00ZG3.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZG3.699; A00ZX7.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZX7.699; A010PH.699 0100867770000209 13180921 17200921 1002-18-0036 21A010PH.699; A00ZC2.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC2.699; A00ZC6.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZC6.699; A00ZH4.699 0100867770000209 13180921 17200921 1002-18-0036 21A00ZH4.699

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2073-2020

Related Recalls

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.

Capso Vision

Class I - Dangerous

Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the patient may need to repeat the exam.

Feb 26, 2020 Diagnostic Equipment Nationwide View Details →

CapsoCAM Plus, UDI: 00867770000209

Capso Vision

Class I - Dangerous

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.

Oct 18, 2019 Other Medical Devices Nationwide View Details →