Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
Medical device recall Z-2331-2023. Published in FDA’s Enforcement Report on Aug 9, 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 Aug 9, 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
- 15,945 kits 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?
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRAPHY PACK, Model Number: DYNJ65963; e. ANGIOPLASTY PACK-LF, Model Number: DYNJ64655; f. ARTHROGRAM TRAY, Model Number: SPEC0232; g. BASIC CATH/ANGIO, Model Number: DYNJ62591A; h. BASIC PACK, Model Number: DYNJ39752A; i. C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B; j. CATH ANGIO PACK, Model Number: DYNJ64050; k. DBD-KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148; l. DBS PACK-LF, Model Number: DYNJ0878178I; m. GENERAL ANGIO PACK, Model Number: DYNJ57760A; n. GHIASSI NEURO ANGIO PACK-LF, Model Number: DYNJ57032C; o. IR NEURO PACK, Model Number: DYNJ39198L, DYNJ39198N; p. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086A; q. MAIN BASIC NEURO, Model Number: DYNJ908260; r. NEURO ACCESSORY PACK, Model Number: DYNJ66790, DYNJ66790A, DYNJ66790B; s. NEURO CATH PACK, Model Number: DYNJ69129, DYNJ83090; t. NEURO IR PACK, Model Number: DYNJ35066I, DYNJ35066J, DYNJ60701A, DYNJ60701B, DYNJ60701C; u. NEURO PACK, Model Number: DYNJ43934A, DYNJ61798D, DYNJ66241, DYNJ66241A, DYNJ66241B, DYNJ66241C, DYNJ66241D, DYNJ68956A, DYNJ68956B; v. NEURO RADIOLOGY PACK, Model Number: DYNJ51107A, DYNJ59903A, DYNJ59903B; w. NEURO TRAY, Model Number: DYNJ67075, DYNJ67075A; x. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112A; y. PEDI ANGIO PACK-LF, Model Number: PHS41743B; z. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755C; aa. RADIOLOGY NEURO DRAPE PAC, Model Number: DYNJ61449; bb. RO-DIEP PACK, Model Number: DYNJ82393A;
15,945 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ905151A, UPC Number: 019348981341. b. Model Number: DYNJ58346A, UPC Number: 019348977463. c.…
Every code shown here, 1,988 characters
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ905151A, UPC Number: 019348981341. b. Model Number: DYNJ58346A, UPC Number: 019348977463. c. Model Number: DYNJ57442C, UPC Number: 019348920853; Model Number: DYNJ64081A, UPC Number: 019348927374. d. Model Number: DYNJ65963, UPC Number: 019348930770. e. Model Number: DYNJ64655, UPC Number: 019348921040. f. Model Number: SPEC0232, UPC Number: 088827750741. g. Model Number: DYNJ62591A, UPC Number: 019348979331. h. Model Number: DYNJ39752A, UPC Number: 088438990723. i. Model Number: DYNJ53064B, UPC Number: 019348978916. j. Model Number: DYNJ64050, UPC Number: 019348978046. k. Model Number: DYKMBNDL148, UPC Number: 019348947839. l. Model Number: DYNJ0878178I, UPC Number: 019348956435. m. Model Number: DYNJ57760A, UPC Number: 019348922023. n. Model Number: DYNJ57032C, UPC Number: 019348945147. o. Model Number: DYNJ39198L, UPC Number: 019348956435 Model Number: DYNJ39198N, UPC Number: 019532710200. p. Model Number: DYNJ906086A, UPC Number: 019348920868. q. Model Number: DYNJ908260, UPC Number: 019532701744. r. Model Number: DYNJ66790, UPC Number: 019348938243; Model Number: DYNJ66790A, UPC Number: 019348992247; Model Number: DYNJ66790B, UPC Number: 019532709926. s. Model Number: DYNJ69129, UPC Number: 019348989241; Model Number: DYNJ83090, UPC Number: 019532723093. t. Model Number: DYNJ35066I, UPC Number: 019348956435; Model Number: DYNJ35066J, UPC Number: 019532709107; Model Number: DYNJ60701A, UPC Number: 019348969378; Model Number: DYNJ60701B, UPC Number: 019348987733; Model Number: DYNJ60701C, UPC Number: 019532703379. u. Model Number: DYNJ43934A, UPC Number: 019348973360; Model Number: DYNJ61798D, UPC Number: 019348999263; Model Number: DYNJ66241, UPC Number: 019348932296; Model Number: DYNJ66241A, UPC Number: 019348993803; Model Number: DYNJ66241B, UPC Number: 019532705348; Model Number: DYNJ66241C, UPC Number:…
FDA’s list runs to 2,697 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.
Barcodes and drug codes
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UPC
019348981341 -
UPC
019348977463 -
UPC
019348920853 -
UPC
019348927374 -
UPC
019348930770 -
UPC
019348921040 -
UPC
088827750741 -
UPC
019348979331 -
UPC
088438990723 -
UPC
019348978916 -
UPC
019348978046 -
UPC
019348947839 -
UPC
019348956435 -
UPC
019348922023 -
UPC
019348945147 -
UPC
019532710200 -
UPC
019348920868 -
UPC
019532701744 -
UPC
019348938243 -
UPC
019348992247 -
UPC
019532709926 -
UPC
019348989241 -
UPC
019532723093 -
UPC
019532709107 -
UPC
019348969378 -
UPC
019348987733 -
UPC
019532703379 -
UPC
019348973360 -
UPC
019348999263 -
UPC
019348932296 -
UPC
019348993803 -
UPC
019532705348 -
UPC
019532709685 -
UPC
019532713837 -
UPC
019348987629 -
UPC
019532709434 -
UPC
019348971558 -
UPC
019532704286 -
UPC
019532713120 -
UPC
019348938847 -
UPC
019532705453 -
UPC
019348924703 -
UPC
019348978493 -
UPC
019348977837 -
UPC
019348956734 -
UPC
019532729232
As FDA’s description and codes give them; the UPCs written as digits only.
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 the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
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 15, 2023.
- FDA classified it on Aug 3, 2023.
- FDA’s Enforcement Report published it on Aug 9, 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 2,697 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.