Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK SUPPLIES NDL…
Medical device recall Z-2181-2023. 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) BLOCK SUPPLIES NDL CNTR, Model Number DYNJRA1755; b) VNUS TEST KIT CFP-LF, Model Number DYNJTESTCFP4; c) ULTRASOUND PIV BUNDLE, Model Number IV8635D; d) ULTRASOUND GUIDED PIV KIT, Model Number IVS3300; e) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3485A; f) EPIV PROCEDURE TRAY, Model Number IVS3825; g) ULTRASOUND GUIDED PIV INSERTIO, Model Number IVS3840A; h) RADIOLOGY TRAY, Model Number MNS11625; i) BEDSIDE PROCEDURE PREP KIT, Model Number MNS7695A; j) NGHS EVOR ANGIO PACK, Model Number NG410A; k) PICC INSERT KIT-LESS THAN 3 FR, Model Number PHS41739A; l) RADIOLOGY SPECIALS PACK, Model Number PHS479840M; m) HYBRID OR PACK, Model Number SYNJ10303B; n) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500A; o) TVS4500 MULTI PURPOSE VEIN, Model Number TVS4500B; p) VC PROCEDURE KIT, Model Number VC-PK
# 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 Number DYNJRA1755, UDI/DI (EA) 10193489842845, UDI/DI (CS) 40193489842846; b) Model Number DYNJTESTCFP4, UDI/DI (EA) 10193489472813, UDI/DI (CS)…
Every code shown here, 1,397 characters
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJRA1755, UDI/DI (EA) 10193489842845, UDI/DI (CS) 40193489842846; b) Model Number DYNJTESTCFP4, UDI/DI (EA) 10193489472813, UDI/DI (CS) 40193489472814; c) Model Number IV8635D, UDI/DI (EA) 10653160990260, UDI/DI (CS) 40653160990261; d) Model Number IVS3300, UDI/DI (EA) 10653160307662, UDI/DI (CS) 40653160307663; e) Model Number IVS3485A, UDI/DI (EA) 10653160990154, UDI/DI (CS) 40653160990155; f) Model Number IVS3825, UDI/DI (EA) 10653160330752, UDI/DI (CS) 40653160330753; g) Model Number IVS3840A, UDI/DI (EA) 10193489476736, UDI/DI (CS) 40193489476737; h) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 40653160322130; i) Model Number MNS7695A, UDI/DI (EA) 10653160343455, UDI/DI (CS) 40653160343456; j) Model Number NG410A, UDI/DI (EA) 10889942945887, UDI/DI (CS) 40889942945888; k) Model Number PHS41739A, UDI/DI (EA) 10889942906802, UDI/DI (CS) 40889942906803; l) Model Number PHS479840M, UDI/DI (EA) 10193489682724, UDI/DI (CS) 40193489682725; m) Model Number SYNJ10303B, UDI/DI (EA) 10193489373745, UDI/DI (CS) 40193489373746; n) Model Number TVS4500A, UDI/DI (EA) 10816982023374, UDI/DI (CS) 40816982023375; o) Model Number TVS4500B, UDI/DI (EA) 10195327223564, UDI/DI (CS) 40195327223565; p) Model Number VC-PK, UDI/DI (EA) 10195327176891, UDI/DI (CS) 40195327176892;
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.”
- 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.