ORAcollect Dx
Medical device recall Z-0981-2022. Published in FDA’s Enforcement Report on Apr 27, 2022.
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 Apr 27, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 38 states named
- 2,375,514 (US: 2,148,222 OUS: 227,292) 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?
Evaporation of stabilizing liquid reducing shelf life.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
2,375,514 (US: 2,148,222 OUS: 227,292), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
627595000309 01006275950003091722091210XI512, Lot XI512 627595000309 01006275950003091722091310XI513, Lot XI513 627595000309 01006275950003091722091410XI514, Lot XI514 627595000309 01006275950003091722091610XI519, Lot XI519 627595000309…
Every code shown here, 1,973 characters
627595000309 01006275950003091722091210XI512, Lot XI512 627595000309 01006275950003091722091310XI513, Lot XI513 627595000309 01006275950003091722091410XI514, Lot XI514 627595000309 01006275950003091722091610XI519, Lot XI519 627595000309 01006275950003091722091610XI520, Lot XI520 627595000309 01006275950003091722091710XI521, Lot XI521 627595000309 01006275950003091722091810XI522, Lot XI522 627595000309 01006275950003091722093010XI534, Lot XI534 627595000309 01006275950003091722102810XJ536, Lot XJ536 627595000309 01006275950003091722102810XJ537, Lot XJ537 627595000309 01006275950003091722111510XK518, Lot XK518 627595000309 01006275950003091722111610XK519, Lot XK519 627595000309 01006275950003091722120310XL503, Lot XL503 627595000309 01006275950003091722120310XL506, Lot XL506 627595000309 01006275950003091722120410XL510, Lot XL510 627595000309 01006275950003091722120510XL511, Lot XL511 627595000309 01006275950003091722120610XL512, Lot XL512 627595000309 01006275950003091722121410XL521, Lot XL521 627595000309 01006275950003091722121510XL522, Lot XL522 627595000309 01006275950003091722123110XL535, Lot XL535 627595000309 01006275950003091723010410YA501, Lot YA501 627595000309 01006275950003091723011110YA510, Lot YA510 627595000309 01006275950003091723011510YA515, Lot YA515 627595000309 01006275950003091723011610YA516, Lot YA516 627595000309 01006275950003091723013010YA531, Lot YA531 627595000309 01006275950003091723013110YA532, Lot YA532 627595000309 01006275950003091723021510YB522, Lot YB522 627595000309 01006275950003091723021610YB523, Lot YB523 627595000309 01006275950003091723022610YB534, Lot YB534 627595000309 01006275950003091723031910YC525, Lot YC525 627595000309 01006275950003091723032010YC526, Lot YC526 627595000309 01006275950003091723032110YC527, Lot YC527 627595000309 01006275950003091723032510YC532, Lot YC532 627595000309 01006275950003091723032610YC533, Lot YC533 627595000309 01006275950003091723041210YD512, Lot YD512 627595000309…
FDA’s list runs to 8,455 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.
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WI and the countries of Australia Belgium, Brazil, Canada, Chile, China, Croatia Denmark, Finland, Germany, Great Britain, Italy, Japan, Netherlands, South Africa, and Thailand.
The states and territories these words name
38 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Feb 18, 2022.
- FDA classified it on Apr 21, 2022.
- FDA’s Enforcement Report published it on Apr 27, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- DNA Genotek Inc., of Kanata, Canada.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
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 8,455 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
-
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.