FDA recall Z-1477-2022
Medical device recall Z-1477-2022. Published in FDA’s Enforcement Report on Aug 3, 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 Aug 3, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 28745 units 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?
Kits contain leaking bottles of isopropyl alcohol
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
FDA’s description of the product isn’t shown here yet: this record is being refreshed. FDA’s own record has it.
28745 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a. Model CDS981510J, Lot Numbers: 22BDB532; b. Model CDS984260I, Lot Numbers: 22CBM678, 22CBM679, 21FBJ127, 21GBV813, 21KBA497; c. Model CDS984263L, Lot Numbers: 22DBD966, 22CBV297, 21GBV822; c. Model DYNJ906469D, Lot Numbers: 22DDA747,…
Every code shown here, 1,995 characters
a. Model CDS981510J, Lot Numbers: 22BDB532; b. Model CDS984260I, Lot Numbers: 22CBM678, 22CBM679, 21FBJ127, 21GBV813, 21KBA497; c. Model CDS984263L, Lot Numbers: 22DBD966, 22CBV297, 21GBV822; c. Model DYNJ906469D, Lot Numbers: 22DDA747, 22DDA652, 22CDC430; c. Model DYNJ908097, Lot Numbers: 22ABN864, 22BBU902, 22BBX706, 21IBO640; c. Model DYNJ906469B, Lot Numbers: 21EDA002, 21HDB515; d. Model DYKMBNDL141, Lot Numbers: 22ABL303, 22BBR667, 22CBV519, 21GBJ360, 21GBO489, 21IBJ315, 21IBK151, 21VBB503, 21CBJ601, 21EBM705, 21FBF908; e. Model DYKMBNDL143, Lot Numbers: 22ABN016, 21KBA482, 21CBS017, 21CBT399; f. Model DYKMBNDL144, Lot Numbers: 22CLA771, 21LLA651, 22BLA947, 21DLA534, 21FLA052, 21GLA640, 21GLA871, 21HLA178, 21HLA660, 21ILA240, 21JLA461, 21KLB158, 21LLA431; g. Model DYKMBNDL145A, Lot Numbers: 22ABL304, 21GBA981, 21GBJ361, 21JBQ909; h. Model DYKMBNDL160A, Lot Numbers: 22DBD150, 21LBX974, 22CBT054, 21FBO540, 21GBB011, 21GBR032, 21HBO270, 21IBU144, 21JBJ233, 21LBP525, 21CBM831, 21EBQ761 i. Model DYKMBNDL5A, Lot Numbers: 22OBI934, 22DBE579, 22ABG023, 22CBX205, 21KBC488, 21LBD743, 21EBG521; j. Model DYNJ44044B, Lot Numbers: 21GBO678, 21GBO688; k. Model DYNJ46505I, Lot Numbers: 21KBK061; l. Model DYNJ46531M, Lot Numbers: 22DBG277, 22DBL697, 22OBB278, 22OBB279, 21JBQ708, 21KBQ426; m. Model DYNJ46533G, Lot Numbers: 21JBH068; n. Model DYNJ56778F, Lot Numbers: 21EBC732; n. Model DYNJ904660D, Lot Numbers: 22BBO231, 22CBB857, 22CBJ576, 21FBM621, 21GBQ436, 21KBD961, 21KBZ632, 21LBI692, 21DBU774; n. Model DYNJ906666J, Lot Numbers: 22DDA329; n. Model DYNJ908094, Lot Numbers: 22DBG252, 22CLA375, 21IBS818, 21KBF456; n. Model DYNJ905337A, Lot Numbers: 21GBB871, 21IBL645, 21VBC385, 21FBE200; n. Model DYNJ906666B, Lot Numbers: 21BDB196; n. Model DYNJ906666C, Lot Numbers: 21EDB515, 21EDB761; n. Model DYNJ906666F, Lot Numbers: 21GDD196, 21IDA250; n. Model DYNJ906666G, Lot Numbers: 21LDB106, 21KDC158; n. Model DYNJ906666I, Lot Numbers: 22CDB427, 22BDC525; n. Model DYNJ907974, Lot…
FDA’s list runs to 10,390 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.
US Nationwide distribution.
These words name no state.
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.
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 Jun 6, 2022.
- FDA classified it on Jul 27, 2022.
- FDA’s Enforcement Report published it on Aug 3, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- MEDLINE INDUSTRIES, LP - SPT, of Waukegan, IL.
- 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 10,390 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.