Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN…
Medical device recall Z-2166-2023. Published in FDA’s Enforcement Report on Jul 26, 2023.
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 Jul 26, 2023. 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
- # included in 3,740,814 units total 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?
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) CUSTOM CARDIAC CABG, Model Number DYNJ906108C; d) VASCULAR STENT INOVA, Model Number DYNJ906440A; e) CABG, Model Number DYNJ906878A; f) VALVE, Model Number DYNJ906882A; g) VASCULAR, Model Number DYNJ906883A; h) DR WILLIAMS HEART, Model Number DYNJ907552A; i) PUH PERCUTANEOUS ECMO, Model Number DYNJ907554C; j) TAVR, Model Number DYNJ907561A; k) TAVR, Model Number DYNJ907561B; l) TAVR, Model Number DYNJ907561C; m) OPEN HEART CDS, Model Number DYNJ907607A; n) OPEN HEART CDS, Model Number DYNJ907607B; o) OPEN HEART CDS, Model Number DYNJ907607C; p) OPEN VASCULAR UE, Model Number DYNJ907858A; q) PACEMAKER, Model Number DYNJ907907; r) DEBOER HEART, Model Number DYNJ907914A; s) DEBOER HEART, Model Number DYNJ907914B; t) DEBOER HEART, Model Number DYNJ907914C; u) GENERAL HEART, Model Number DYNJ907915; v) AV FISTULA, Model Number DYNJ907975; w) AV FISTULA, Model Number DYNJ907975A; x) AV FISTULA, Model Number DYNJ907975B; y) SAC OPEN HEART DR. RUDERSDORF, Model Number DYNJ908074B; z) CARDIAC CABG B, Model Number DYNJ908121B; aa) OPEN HEART LINE SET UP, Model Number DYNJ908179A; bb) STEWARD VASCULAR SAS, Model Number DYNJ908563; cc) TAVR, Model Number DYNJ908646; dd) TAVR, Model Number DYNJ908646A; ee) ENDOVASCULAR, Model Number DYNJ908880; ff) ENDOVASCULAR, Model Number DYNJ908880A; gg) VASCULAR, Model Number DYNJ909091; hh) ENDOVASCULAR, Model Number DYNJ909253; ii) TAVR, Model Number DYNJ909270; jj) CABG, Model Number DYNJ9372030G; kk) OPEN HEART, Model Number DYNJ9718008AS; ll) ADULT CORONARY PACK, Model Number DYNJV0275M; mm) RADIOLOGY SPECIALS TRAY, Model Number DYNJVB1302A; nn) VASCULAR PACK, Model Number DYNJVB1307; oo) VASCULAR PACK, Model Number DYNJVB1307A; pp) VASCULAR EXTREMITY PPS, Model Number DYNJVB91063C; qq) ENDOVASCULAR #IMF 88370-LF, Model Number DYNJVB91067; rr) PERIPHERAL CONTINUOUS NERVE BL, Model Number PAIN1423A; ss) VEIN PACK-LF, Model Number PHS151095000; tt) E P PACK-LF, Model Number PHS41732B; uu) PICC VASCULAR ACCESS PACK, Model Number PICCNC0010; vv) TVS4000 ENDOVENOUS PACK, Model Number TVS4000L;
# included in 3,740,814 units total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Numbers DYNJ906102G, UDI/DI (EA)10195327290795, UDI/DI (CS)40195327290796; b) Model Numbers DYNJ906102I, UDI/DI (EA)10195327323349, UDI/DI…
Every code shown here, 1,992 characters
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Numbers DYNJ906102G, UDI/DI (EA)10195327290795, UDI/DI (CS)40195327290796; b) Model Numbers DYNJ906102I, UDI/DI (EA)10195327323349, UDI/DI (CS)40195327323340; c) Model Numbers DYNJ906108C, UDI/DI (EA)10195327118273, UDI/DI (CS)40195327118274; d) Model Numbers DYNJ906440A, UDI/DI (EA)10193489312874, UDI/DI (CS)40193489312875; e) Model Numbers DYNJ906878A, UDI/DI (EA)10193489391305, UDI/DI (CS)40193489391306; f) Model Numbers DYNJ906882A, UDI/DI (EA)10193489391237, UDI/DI (CS)40193489391238; g) Model Numbers DYNJ906883A, UDI/DI (EA)10193489398205, UDI/DI (CS)40193489398206; h) Model Numbers DYNJ907552A, UDI/DI (EA)10195327166052, UDI/DI (CS)40195327166053; i) Model Numbers DYNJ907554C, UDI/DI (EA)10195327183837, UDI/DI (CS)40195327183838; j) Model Numbers DYNJ907561A, UDI/DI (EA)10195327028848, UDI/DI (CS)40195327028849; k) Model Numbers DYNJ907561B, UDI/DI (EA)10195327290832, UDI/DI (CS)40195327290833; l) Model Numbers DYNJ907561C, UDI/DI (EA)10195327323271, UDI/DI (CS)40195327323272; m) Model Numbers DYNJ907607A, UDI/DI (EA)10193489873405, UDI/DI (CS)40193489873406; n) Model Numbers DYNJ907607B, UDI/DI (EA)10195327174194, UDI/DI (CS)40195327174195; o) Model Numbers DYNJ907607C, UDI/DI (EA)10195327335519, UDI/DI (CS)40195327335510; p) Model Numbers DYNJ907858A, UDI/DI (EA)10195327131357, UDI/DI (CS)40195327131358; q) Model Numbers DYNJ907907, UDI/DI (EA)10193489939736, UDI/DI (CS)40193489939737; r) Model Numbers DYNJ907914A, UDI/DI (EA)10195327149529, UDI/DI (CS)40195327149520; s) Model Numbers DYNJ907914B, UDI/DI (EA)10195327180607, UDI/DI (CS)40195327180608; t) Model Numbers DYNJ907914C, UDI/DI (EA)10195327329433, UDI/DI (CS)40195327329434; u) Model Numbers DYNJ907915, UDI/DI (EA)10193489943689, UDI/DI (CS)40193489943680; v) Model Numbers DYNJ907975, UDI/DI (EA)10193489965605, UDI/DI (CS)40193489965606; w) Model Numbers DYNJ907975A, UDI/DI (EA)10195327155070, UDI/DI…
FDA’s list runs to 4,122 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) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
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.
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 May 18, 2023.
- FDA classified it on Jul 20, 2023.
- FDA’s Enforcement Report published it on Jul 26, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- MEDLINE INDUSTRIES, LP - Northfield, of Northfield, 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 4,122 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.