Hearth Record

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel

Medical device recall Z-2320-2023. Published in FDA’s Enforcement Report on Aug 9, 2023.

FDA’s own record, on accessdata.fda.gov

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.

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.

Source:

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.

Source:

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. DR. ROSEN VEIN PACK, Model Number: DYNJ67517; b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B; c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A; d. ECMO PACK, Model Number: DYNJ61243; e. EGG RETRIEVAL PACK, Model Number: DYNJ66291, DYNJ66291A; f. EH TAVR PACK, Model Number: DYNJ57449A; g. ELVS PACK-LF, Model Number: DYNJ26940G; h. ENDO AAA HYBRID CHRG, Model Number: DYNJ60126; i. ENDOVASCULAR OR PACK, Model Number: DYNJ54265; j. ENDOVASCULAR PACK, Model Number: DYNJ59085; k. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831D; l. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435C; m. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456B; n. ENDOVENOUS CORE PACK, Model Number: DYNJ59168; o. ENDOVENOUS PACK, Model Number: DYNJ58228; p. ENS BIOPSIE THYROIDE-HEJ-LF, Model Number: DYNJ62443; q. EP LAB, Model Number: DYNJ59392C; r. EP MERCY JANESVILLE, Model Number: DYNJ907013; s. EP PACK, Model Number: DYNJ57594A; t. EVAR, Model Number: DYNJ900005L; u. EVLA PACK, Model Number: DYNJ66258; v. EVLT, Model Number: DYNJ62417, DYNJ64336; w. EVLT CORE PACK, Model Number: DYNJ45294; x. EVLT PACK, Model Number: DYNJ38674A, DYNJ45997C, DYNJ56548B, DYNJ65995, DYNJ65995A, DYNJ66005; y. FEM POP PACK, Model Number: DYNJ01964M, DYNJ67487A; z. FETAL OPEN/EXIT, Model Number: DYNJ904069C; aa. FH THORACIC PACK, Model Number: DYNJ58572B, DYNJ58572C; bb. FISTULAGRAM/C-ACCESS PACK, Model Number: DYNJ59657A; cc. FLAP, Model Number: DYNJ905146A; dd. FREE FLAP PACK CTX, Model Number: DYNJ68380C; ee. FREE FLAP PACK-LF, Model Number: DYNJ0271254P; ff. FREE FLAP TRAM ADD ON PACK, Model Number: DYNJ82179; gg. GEL ULTRASOUND 20G FOIL , Model Number: DYNJZ45357; hh. GENERAL USE PACK, Model Number: DYNJ41137B; ii. GU ROBOTIC PACK-LF, Model Number: DYNJ0972464Y; jj. GYN LITHOTOMY, Model Number: DYNJ906579C; kk. HH VARITHENA VEIN PACK, Model Number: DYNJ59500; ll. HH VEIN CLOSURE PACK, Model Number: DYNJ59501; mm. HH VEIN PICC MADISON PACK, Model Number: DYNJ59508; nn. HILLCREST PCNL PACK, Model Number: DYNJ69204B; oo. HL VEIN STRIPPING PACK, Model Number: DYNJ40374A; pp. HYBRID KIT, Model Number: DYNJ905335; qq. HYBRID OR PACK, Model Number: SYNJ10303B; rr. I.R. PACK, Model Number: DYNJ60343A; ss. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708F; tt. IR MINI KIT, Model Number: DYNJ44519F; uu. IR NEURO PACK, Model Number: DYNJ39198I; vv. IR PERIPHERAL PACK, Model Number: DYNJ45033A; ww. IR SONO PACK, Model Number: DYNDA2365, DYNDA2365B; xx. JBMH EVAR PACK, Model Number: DYNJ69820; yy. JOHNSON OH ACCESSORY PACK, Model Number: DYNJ51927A; zz. JUDKINS PACK-LF, Model Number: DYNJ0530948AR, DYNJ0586030P; aaa. JVL-PACK TUNNELED, Model Number: DYNJ66065; bbb. KF PACK, Model Number: DYNJ57547, DYNJ58647, DYNJ60127A; ccc. KF PACK 2.0, Model Number: DYNJ69619; ddd. KIDNEY CDS, Model Number: DYNJ903873C; eee. KIDNEY TRANSPLANT, Model Number: DYNJ905682; fff. KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173B; ggg. KIT LB OPEN HEART, Model Number: DYNJ902261D, DYNJ904401B; hhh. KT TAVR PACK, Model Number: DYNJ56283B; iii. LARGE PROCEDURE PACK, Model Number: DYNJ35524D; jjj. LASER ABLATION, Model Number: DYNJ80299; kkk. LASER KIT, Model Number: DYNJ64075A; lll. LASER PACK, Model Number: DYNJ39053A; mmm. LINE KIT, Model Number: DYNJ47987B; nnn. LINE PLACEMENT PACK-LF, Model Number: DYNJ0931376F; ooo. LIVER 2018, Model Number: DYNJ905655, DYNJ905655B; ppp. LIVER TRANSPLANT CDS, Model Number: CDS984951D; qqq. LIVER TRANSPLANT PACK, Model Number: DYNJ0271349T; rrr. LONESTAR RF PACK, Model Number: DYNJ83152; sss. MAD PERIPHERAL VASCULAR-LF, Model Number: DYNJ902168D; ttt. MAG FREE FLAP CDS-LF,

93,587 kits, in FDA’s words.

Source:

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: DYNJ67517, UPC Number: 019348940782. b. Model Number: DYNJ51416B, UPC Number: 088827774647. c.…

Every code shown here, 1,994 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: DYNJ67517, UPC Number: 019348940782. b. Model Number: DYNJ51416B, UPC Number: 088827774647. c. Model Number: DYNJ42913, UPC Number: 088827701320; Model Number: DYNJ42913A, UPC Number: 019532708060. d. Model Number: DYNJ61243, UPC Number: 019348955091. e. Model Number: DYNJ66291, UPC Number: 019348932808, Model Number: DYNJ66291A, UPC Number: 019348948000. f. Model Number: DYNJ57449A, UPC Number: 088994282753. g. Model Number: DYNJ26940G, UPC Number: 019348954079. h. Model Number: DYNJ60126, UPC Number: 088994295193. i. Model Number: DYNJ54265, UPC Number: 088994247400. j. Model Number: DYNJ59085, UPC Number: 088994293201. k. Model Number: DYNJ42831D, UPC Number: 088994284953. l. Model Number: DYNJ53435C, UPC Number: 019348920086. m. Model Number: DYNJ48456B, UPC Number: 088994273317. n. Model Number: DYNJ59168, UPC Number: 088827776444. o. Model Number: DYNJ58228, UPC Number: 088994283549. p. Model Number: DYNJ62443, UPC Number: 019348967919. q. Model Number: DYNJ59392C, UPC Number: 019348928224. r. Model Number: DYNJ907013, UPC Number: 019348931863. s. Model Number: DYNJ57594A, UPC Number: 088994296321. t. Model Number: DYNJ900005L, UPC Number: 019348930031. u. Model Number: DYNJ66258, UPC Number: 019348932547. v. Model Number: DYNJ62417, UPC Number: 019348965705; Model Number: DYNJ64336, UPC Number: 019348980187. w. Model Number: DYNJ45294, UPC Number: 088827709897. x. Model Number: DYNJ38674A, UPC Number: 019348956435; Model Number: DYNJ45997C, UPC Number: 088994268436; Model Number: DYNJ56548B, UPC Number: 019348981318; Model Number: DYNJ65995, UPC Number: 019348931154; Model Number: DYNJ65995A, UPC Number: 019532706812; Model Number: DYNJ66005, UPC Number: 019348931254. y. Model Number: DYNJ01964M, UPC Number: 019348956435; Model Number: DYNJ67487A, UPC Number: 019348988899. z. Model Number: DYNJ904069C, UPC Number:…

FDA’s list runs to 7,146 characters. The first part is shown; the rest is on FDA’s record.

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Barcodes and drug codes

  • UPC 019348940782
  • UPC 088827774647
  • UPC 088827701320
  • UPC 019532708060
  • UPC 019348955091
  • UPC 019348932808
  • UPC 019348948000
  • UPC 088994282753
  • UPC 019348954079
  • UPC 088994295193
  • UPC 088994247400
  • UPC 088994293201
  • UPC 088994284953
  • UPC 019348920086
  • UPC 088994273317
  • UPC 088827776444
  • UPC 088994283549
  • UPC 019348967919
  • UPC 019348928224
  • UPC 019348931863
  • UPC 088994296321
  • UPC 019348930031
  • UPC 019348932547
  • UPC 019348965705
  • UPC 019348980187
  • UPC 088827709897
  • UPC 019348956435
  • UPC 088994268436
  • UPC 019348981318
  • UPC 019348931154
  • UPC 019532706812
  • UPC 019348931254
  • UPC 019348988899
  • UPC 019348999549
  • UPC 019348989338
  • UPC 019532714262
  • UPC 019348954461
  • UPC 019348956922
  • UPC 019532734124
  • UPC 019532708953
  • UPC 019532718266
  • UPC 088994237354
  • UPC 088994226087
  • UPC 019348978326
  • UPC 019532702356
  • UPC 088827775013
  • UPC 088827775014
  • UPC 088827775130
  • UPC 019532736422
  • UPC 088827755794
  • UPC 088994287589
  • UPC 019348937374
  • UPC 019348957383
  • UPC 019348972521
  • UPC 019348946747
  • UPC 019348947580
  • UPC 019348951634
  • UPC 019348983644
  • UPC 019348998143
  • UPC 088827779416
  • UPC 019532714188
  • UPC 088994294714
  • UPC 019348931918
  • UPC 088994275104
  • UPC 088994287545
  • UPC 019348972904
  • UPC 019348995944
  • UPC 019348946309
  • UPC 088827779190
  • UPC 019532724075
  • UPC 088994275524
  • UPC 019348968343
  • UPC 019348969525
  • UPC 019348976610
  • UPC 019532702193
  • UPC 019348923132
  • UPC 019348986737
  • UPC 019348927150
  • UPC 088827778885
  • UPC 019532713015
  • UPC 019348925779
  • UPC 019532708969
  • UPC 019532723708
  • UPC 019348986615
  • UPC 019348946493
  • UPC 019348949239
  • UPC 088994242854
  • UPC 088994276548
  • UPC 088994286443
  • UPC 019348987717
  • UPC 088994205551
  • UPC 019532706928
  • UPC 088994272434
  • UPC 019348938162
  • UPC 088994273341
  • UPC 088994214185
  • UPC 088994273342
  • UPC 088994291165
  • UPC 019348920048
  • UPC 088827798141
  • UPC 088994294588
  • UPC 019348977143
  • UPC 019532725057
  • UPC 065316035433
  • UPC 019348975467
  • UPC 019348931026
  • UPC 019532706202
  • UPC 019532713938
  • UPC 019348957757
  • UPC 019532719797
  • UPC 019348974295
  • UPC 019348924708
  • UPC 019348944364
  • UPC 019348928093
  • UPC 019532730355
  • UPC 088994261150
  • UPC 10889942611508
  • UPC 088994243165
  • UPC 088994265471
  • UPC 088994274223
  • UPC 019348911124
  • UPC 019532729771
Source:

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.

Source:

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.

Source:

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.
Source:

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.
Source:

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 7,146 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

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Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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