The CapsoCam Plus recall
The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for…
Why was The CapsoCam Plus recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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 010086777000020913200204172107011001-19-007021A01536.700; S/N A015AJ.700, UDI 010086777000020913200204172107011001-19-007021A015AJ.700; S/N A015DD.700, UDI 010086777000020913200204172107011001-19-007021A015DD.700; S/N A015FB.700, UDI 010086777000020913200204172107011001-19-007021A015FB.700; S/N A015MK.700, UDI 010086777000020913200204172107011001-19-007021A015MK.700; S/N A015S1.700, UDI 010086777000020913200204172107011001-19-007021A015S1.700; S/N A015S2.700, UDI 010086777000020913200204172107011001-19-007021A015S2.700; S/N A015S9.700, UDI 010086777000020913200204172107011001-19-007021A015S9.700; S/N A015T3.700, UDI 010086777000020913200204172107011001-19-007021A015T3.700; S/N A015V7.700, UDI 010086777000020913200204172107011001-19-007021A015V7.700; S/N A015WH.700, UDI 010086777000020913200204172107011001-19-007021A015WH.700; S/N A015YC.700, UDI 010086777000020913200204172107011001-19-007021A015YC.700; S/N A01605.700, UDI 010086777000020913200204172107011001-19-007021A01605.700; S/N A016B1.700, UDI 010086777000020913200204172107011001-19-007021A016B1.700; S/N A016EN.700, UDI 010086777000020913200204172107011001-19-007021A016EN.700; S/N A016G4.700, UDI 010086777000020913200204172107011001-19-007021A016G4.700; S/N A016G7.700, UDI 010086777000020913200204172107011001-19-007021A016G7.700; S/N A016JB.700, UDI 010086777000020913200204172107011001-19-007021A016JB.700; S/N A01878.700, UDI 010086777000020913200204172107011001-19-007021A01878.700; S/N A01880.700, UDI 010086777000020913200204172107011001-19-007021A01880.700; S/N A0188Z.700, UDI 010086777000020913200204172107011001-19-007021A0188Z.700; S/N A0189M.700, UDI 010086777000020913200204172107011001-19-007021A0189M.700; S/N A018BZ.700, UDI 010086777000020913200204172107011001-19-007021A018BZ.700; S/N A018D2.700, UDI 010086777000020913200204172107011001-19-007021A018D2.700; S/N A018DY.700, UDI 010086777000020913200204172107011001-19-007021A018DY.700; S/N A018T7.700, UDI 010086777000020913200204172107011001-19-007021A018T7.700; S/N A018TA.700, UDI 010086777000020913200204172107011001-19-007021A018TA.700; S/N A018TD.700, UDI 010086777000020913200204172107011001-19-007021A018TD.700; S/N A018TF.700, UDI 010086777000020913200204172107011001-19-007021A018TF.700; S/N A018TN.700, UDI 010086777000020913200204172107011001-19-007021A018TN.700; S/N A018UC.700, UDI 010086777000020913200204172107011001-19-007021A018UC.700; S/N A018UL.700, UDI 010086777000020913200204172107011001-19-007021A018UL.700; S/N A018VF.700, UDI 010086777000020913200204172107011001-19-007021A018VF.700; S/N A018VG.700, UDI 010086777000020913200204172107011001-19-007021A018VG.700; S/N A018X5.700, UDI 010086777000020913200204172107011001-19-007021A018X5.700; S/N A018XP.700, UDI 010086777000020913200204172107011001-19-007021A018XP.700; S/N A018YR.700, UDI 010086777000020913200204172107011001-19-007021A018YR.700; S/N A01901.700, UDI 010086777000020913200204172107011001-19-007021A01901.700; S/N A0190B.700, UDI 010086777000020913200204172107011001-19-007021A0190B.700; S/N A0191F.700, UDI 010086777000020913200204172107011001-19-007021A0191F.700; S/N A0191L.700, UDI 010086777000020913200204172107011001-19-007021A0191L.700; S/N A0192C.700, UDI 010086777000020913200204172107011001-19-007021A0192C.700; S/N A0192G.700, UDI 010086777000020913200204172107011001-19-007021A0192G.700; S/N A0192J.700, UDI 010086777000020913200204172107011001-19-007021A0192J.700; S/N A0192X.700, UDI 010086777000020913200204172107011001-19-007021A0192X.700; S/N A0192Y.700, UDI 010086777000020913200204172107011001-19-007021A0192Y.700; S/N A01936.700, UDI 010086777000020913200204172107011001-19-007021A01936.700; S/N A0193A.700, UDI 010086777000020913200204172107011001-19-007021A0193A.700; S/N A0193S.700, UDI 010086777000020913200204172107011001-19-007021A0193S.700; S/N A0194A.700, UDI 010086777000020913200204172107011001-19-007021A0194A.700; S/N A0194D.700, UDI 010086777000020913200204172107011001-19-007021A0194D.700; S/N A0194K.700, UDI 010086777000020913200204172107011001-19-007021A0194K.700; S/N A0194P.700, UDI 010086777000020913200204172107011001-19-007021A0194P.700; S/N A0194X.700, UDI 010086777000020913200204172107011001-19-007021A0194X.700; S/N A01950.700, UDI 010086777000020913200204172107011001-19-007021A01950.700; S/N A0195S.700, UDI 010086777000020913200204172107011001-19-007021A0195S.700; S/N A0195Y.700, UDI 010086777000020913200204172107011001-19-007021A0195Y.700; S/N A01968.700, UDI 010086777000020913200204172107011001-19-007021A01968.700; S/N A0196W.700, UDI 010086777000020913200204172107011001-19-007021A0196W.700; S/N A0196Y.700, UDI 010086777000020913200204172107011001-19-007021A0196Y.700; S/N A0196Z.700, UDI 010086777000020913200204172107011001-19-007021A0196Z.700; S/N A01970.700, UDI 010086777000020913200204172107011001-19-007021A01970.700; S/N A0197C.700, UDI 010086777000020913200204172107011001-19-007021A0197C.700; S/N A0197W.700, UDI 010086777000020913200204172107011001-19-007021A0197W.700; S/N A01986.700, UDI 010086777000020913200204172107011001-19-007021A01986.700; S/N A0198Z.700, UDI 010086777000020913200204172107011001-19-007021A0198Z.700; S/N A01994.700, UDI 010086777000020913200204172107011001-19-007021A01994.700; S/N A0199V.700, UDI 010086777000020913200204172107011001-19-007021A0199V.700; S/N A0199Y.700, UDI 010086777000020913200204172107011001-19-007021A0199Y.700; S/N A019A1.700, UDI 010086777000020913200204172107011001-19-007021A019A1.700; S/N A019AN.700, UDI 010086777000020913200204172107011001-19-007021A019AN.700.
- Product
- The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for…
- Recalling firm
- Capso Vision, Inc.
- Quantity
- 82
- Distribution
- US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA.
- Recall date
- July 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)