FDA Device recall Z-2536-2020

The CapsoCam Plus (SV-3)

FDA Device
Class II
terminated
Published 2020-07-15

On 2020-07-15 the FDA classified a Class II recall of The CapsoCam Plus (SV-3) by Capso Vision, citing 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 d….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2536-2020
Classification	Class II
Status	terminated
Initiated	2020-02-26
Published	2020-07-15
Last updated	2026-09-13 11:55 UTC
Company	Capso Vision
Distribution	US

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.

Reason

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.

Identifiers

code_info	Lot number 01-19-0070 with the following S/N and associated UDIs: S/N A00Y2K.700, UDI 01008677700002091320020417210701… Lot number 01-19-0070 with the following S/N and associated UDIs: S/N A00Y2K.700, 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, UDI 010086777000020913200204172107011001-19-007021A01535.700; S/N A01536.700, UDI 010086777000020913200204172107011001-19-0070

code_info

Lot number 01-19-0070 with the following S/N and associated UDIs: S/N A00Y2K.700, UDI 01008677700002091320020417210701…

Lot number 01-19-0070 with the following S/N and associated UDIs: S/N A00Y2K.700, 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, UDI 010086777000020913200204172107011001-19-007021A01535.700; S/N A01536.700, UDI 010086777000020913200204172107011001-19-0070

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2536-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.