CapsoCAM Plus, UDI: 00867770000209
Medical device recall Z-1827-2020. Published in FDA’s Enforcement Report on May 6, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 6, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 11 states named in where it went
- 1882 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CapsoCAM Plus, UDI: 00867770000209
1882, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: A017NP.699 A0168D.699 A016RR.699 A016W3.699 A016SA.699 A0175B.699 A016SY.699 A017AY.699 A016T0.699 A017D6.699 A016U9.699 A017NF.699 A016VC.699 A017Q0.699 A016XA.699 A017Q3.699 A016YB.699 A0189A.699 A016Z5.699 A018BB.699…
Every code shown here, 1,996 characters
Serial Numbers: A017NP.699 A0168D.699 A016RR.699 A016W3.699 A016SA.699 A0175B.699 A016SY.699 A017AY.699 A016T0.699 A017D6.699 A016U9.699 A017NF.699 A016VC.699 A017Q0.699 A016XA.699 A017Q3.699 A016YB.699 A0189A.699 A016Z5.699 A018BB.699 A0171D.699 A018C5.699 A0171W.699 A018FY.699 A0172S.699 A018JF.699 A0173D.699 A0195K.699 A01749.699 A016FA.699 A0174N.699 A017GD.699 A0175J.699 A0180X.699 A0176P.699 A0182Z.699 A01772.699 A0186Q.699 A0177Q.699 A0187Y.699 A0178D.699 A0189J.699 A0178F.699 A0189X.699 A0178G.699 A018FS.699 A0178S.699 A018J3.699 A0178W.699 A0192E.699 A01790.699 A016CV.699 A01794.699 A016D1.699 A01799.699 A016D4.699 A0179E.699 A016D6.699 A0179H.699 A016DA.699 A0179K.699 A016DB.699 A0179P.699 A016DF.699 A0179Q.699 A016DH.699 A0179R.699 A016DP.699 A0179S.699 A016DQ.699 A0179W.699 A016ET.699 A0179Y.699 A016EV.699 A017AH.699 A016F3.699 A017AP.699 A016F8.699 A017AS.699 A016FN.699 A017B8.699 A016FR.699 A017BH.699 A016FX.699 A017BJ.699 A016FY.699 A017BK.699 A016FZ.699 A017BP.699 A016G3.699 A017BS.699 A016G9.699 A017BU.699 A016GA.699 A017C7.699 A016GF.699 A017CD.699 A016GK.699 A017CE.699 A016GM.699 A017CN.699 A016GS.699 A017CP.699 A016H1.699 A017CX.699 A016HQ.699 A017D5.699 A016JE.699 A017DD.699 A016JP.699 A017DF.699 A016JX.699 A017DG.699 A016K1.699 A017DR.699 A016K3.699 A017E1.699 A016K7.699 A017EC.699 A016KK.699 A017EF.699 A016KX.699 A017EH.699 A016L6.699 A017EK.699 A016L9.699 A017ER.699 A016LF.699 A017EV.699 A016LJ.699 A017EY.699 A016LU.699 A017F5.699 A016LX.699 A017F6.699 A016M0.699 A017FE.699 A016M3.699 A017FJ.699 A016M7.699 A017FL.699 A016M8.699 A017FM.699 A016MB.699 A017FP.699 A016ME.699 A017FR.699 A0179L.699 A017FT.699 A017G1.699 A017FX.699 A017LN.699 A017G2.699 A017Q2.699 A017G5.699 A017RE.699 A017GB.699 A017UG.699 A017GJ.699 A016D9.699 A017GL.699 A016J9.699 A017GN.699 A016L3.699 A017GS.699 A017AV.699 A017GT.699 A017FV.699 A017GU.699 A017QL.699 A017GV.699 A017UK.699 A017GY.699 A016CP.699 A017H1.699 A016CS.699 A017H4.699 A016CU.699 A017H6.699 A016CW.699…
FDA’s list runs to 20,737 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
U.S.: CA, TX, FL, VA, PA, SC, HI, DC, NJ, UT, LA. Foreign: FR, AR, IT, UK, BE, TC, AU, CO, GM, GR, SP, SI, HR, MO, SW, EZ.
The states and territories these words name
- California
- District of Columbia
- Florida
- Hawaii
- Louisiana
- New Jersey
- Pennsylvania
- South Carolina
- Texas
- Utah
- Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 18, 2019.
- FDA classified it on Apr 30, 2020.
- FDA’s Enforcement Report published it on May 6, 2020.
- FDA terminated it on Jan 8, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Capso Vision, Inc., of Saratoga, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 20,737 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.