Hearth Record

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

Medical device recall Z-2301-2023. 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. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G; d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C; e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567; f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N; g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880; h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K; i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067; j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F; k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D; l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F; m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C; n. ENDOVENOUS ABLATION PACK, Model Number: DYNJ80489; o. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456C, DYNJ69108A; p. ENDOVENOUS PACK, Model Number: DYNJ83606; q. ENT FREE FLAP, Model Number: SYNJ910018B; r. EP ANGIO PACK, Model Number: DYNJ25749S; s. EP DRAPE PACK-LF, Model Number: DYNJ47645C; t. EP LAB, Model Number: DYNJ59392D, DYNJ59392F; u. EP PACER PACK, Model Number: DYNJ67770; v. EP PACK, Model Number: DYNJ23456K, DYNJ68019, DYNJ81716, DYNJ81716A, DYNJ81716B; w. EP PROCEDURE PACK, Model Number: DYNJ67771; x. EP TRAY, Model Number: DYNJ31928D; y. FEM POP BYPASS PACK-LF, Model Number: DYNJ53480F; z. FEM POP PACK, Model Number: DYNJ67487C; aa. FISTULA PACK, Model Number: DYNJ82711; bb. FISTULA SAVANNAH PACK, Model Number: DYNJ69943A; cc. GENERAL HEART, Model Number: DYNJ907915; dd. GROTH LASER VEIN CDS, Model Number: CDS984193O; ee. GV PERIPHERAL VASCULAR PACK, Model Number: DYNJ46590I, DYNJ46590J, DYNJ46590K; ff. GWINNETT ENDOVASCULAR WSTE MGT, Model Number: DYNJ68198; gg. HCP OPEN HEART ACCESSORY PACK, Model Number: DYNJ51925F; hh. HEART A PACK, Model Number: DYNJ0541930N; ii. HEART FAILURE PACK, Model Number: DYNJ64877B; jj. HEART FAILURE PK, Model Number: DYNJ55528A, DYNJ55528B, DYNJ55528C; kk. HEART PACK, Model Number: DYNJ48424A; ll. HEART VALVE PACK, Model Number: DYNJ58365C, DYNJ58365F, DYNJ58365G, DYNJ58365J; mm. HEART VEIN NYC-ARTERIAL PACK, Model Number: DYNJ62851B; nn. HEART VEIN NYC LASER ABLATION, Model Number: DYNJ62850A; oo. HMT TAVR, Model Number: DYNJ905495D, DYNJ905495F; pp. HMT VEIN PACK, Model Number: DYNJ38756B; qq. HP MINOR VASCULAR, Model Number: DYNJ907571A, DYNJ907571B; rr. INTERVENTIONAL RAD L J-LF, Model Number: DYNJ40215C; ss. INTERVENTIONAL RADIOLOGY, Model Number: DYNJ52756A; tt. INTERVENTIONAL RADIOLOGY PACK, Model Number: DYNJ47138B; uu. IR ANGIOGRAM LIGHT PK, Model Number: DYNJ82858A; vv. IR ANGIOGRAM PACK, Model Number: DYNJ82859A; ww. JVL-PACK VNUS CLOSURE, Model Number: DYNJ66076; xx. KIT CARDIAC ROBOTIC MID CAB, Model Number: DYKMBNDL22C; yy. KIT LB OPEN HEART, Model Number: CDS840487G; zz. KIT MAJOR VASCULAR, Model Number: DYNJ907262, DYNJ907262B; aaa. KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148A; bbb. KIT OPEN HEART, Model Number: DYNJ906113; ccc. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086B; ddd. KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23; eee. KIT VASCULAR ACCESS PHT, Model Number: DYNJ906098, DYNJ906098A; fff. KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; ggg. KIT VASCULAR RF, Model Number: DYNJ906960A; hhh. KT TAVR PACK, Model Number: DYNJ56283C, DYNJ56283D, DYNJ56283F; iii. LASER ABLATION, Model Number: DYNJ48962B; jjj. LASER AND VEIN PACK, Model Number: DYNJ38995C, DYNJ67725; kkk. LASER PACK, Model Number: DYNJ65294; lll. LB OPEN HEART BOX, Model Number: DYNJ905859B; mmm. LEE VEIN PACK, Model Number: DYNJ54906B; nnn. LEG VASCULAR SUPPLY -LF, Model Number: D

41,123 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: DYNJ0842825D, UPC Number: 019532728861. b. Model Number: DYNJ49933I, UPC Number: 019348947168;…

Every code shown here, 1,993 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: DYNJ0842825D, UPC Number: 019532728861. b. Model Number: DYNJ49933I, UPC Number: 019348947168; Model Number: DYNJ49933J, UPC Number: 019532706561. c. Model Number: DYNJ44808G, UPC Number: 019348987585. d. Model Number: DYNJ51304B, UPC Number: 088994236595; Model Number: DYNJ51304C, UPC Number: 019348946098. e. Model Number: DYNJ0678934D, UPC Number: 019348956435; Model Number: DYNJ0678934F, UPC Number: 019348956435; Model Number: DYNJ82567, UPC Number: 019532719803. f. Model Number: DYNJ0676055N, UPC Number: 019348956435. g. Model Number: DYNJ63343A, UPC Number: 019348929199; Model Number: DYNJ63343B, UPC Number: 019348947045; Model Number: DYNJ63343D, UPC Number: 019348996760; Model Number: DYNJ63343F, UPC Number: 019532708613; Model Number: DYNJ908880, UPC Number: 019532720343. h. Model Number: CDS983394I, UPC Number: 019348981995; Model Number: CDS983394J, UPC Number: 019532706987; Model Number: CDS983394K, UPC Number: 019532729258. i. Model Number: DYNJVB91067, UPC Number: 019348980153. j. Model Number: DYNJ906354D, UPC Number: 019348998657; Model Number: DYNJ906354F, UPC Number: 019532702150. k. Model Number: DYNJ0678934I, UPC Number: 019348999786; Model Number: DYNJ44934F, UPC Number: 019348944613; Model Number: DYNJ905726C, UPC Number: 019348994337; Model Number: DYNJ905726D, UPC Number: 019532716151. l. Model Number: DYNJ42831F, UPC Number: 019348988032. m. Model Number: DYNJ67750, UPC Number: 019348942917, Model Number: DYNJ67750A, UPC Number: 019348983224, Model Number: DYNJ67750B, UPC Number: 019348991204, Model Number: DYNJ67750C, UPC Number: 019532734136. n. Model Number: DYNJ80489, UPC Number: 019532704584. o. Model Number: DYNJ48456C, UPC Number: 019532701586; Model Number: DYNJ69108A, UPC Number: 019532702571. p. Model Number: DYNJ83606, UPC Number: 019532728485. q. Model Number: SYNJ910018B, UPC Number:…

FDA’s list runs to 9,894 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 019532728861
  • UPC 019348947168
  • UPC 019532706561
  • UPC 019348987585
  • UPC 088994236595
  • UPC 019348946098
  • UPC 019348956435
  • UPC 019532719803
  • UPC 019348929199
  • UPC 019348947045
  • UPC 019348996760
  • UPC 019532708613
  • UPC 019532720343
  • UPC 019348981995
  • UPC 019532706987
  • UPC 019532729258
  • UPC 019348980153
  • UPC 019348998657
  • UPC 019532702150
  • UPC 019348999786
  • UPC 019348944613
  • UPC 019348994337
  • UPC 019532716151
  • UPC 019348988032
  • UPC 019348942917
  • UPC 019348983224
  • UPC 019348991204
  • UPC 019532734136
  • UPC 019532704584
  • UPC 019532701586
  • UPC 019532702571
  • UPC 019532728485
  • UPC 019532700730
  • UPC 019532705970
  • UPC 019532735517
  • UPC 019532705357
  • UPC 019532713598
  • UPC 019348943071
  • UPC 019348996776
  • UPC 019348946784
  • UPC 019532713806
  • UPC 019532720385
  • UPC 019532727726
  • UPC 019348943072
  • UPC 019532733528
  • UPC 019348942488
  • UPC 019532726074
  • UPC 019532720362
  • UPC 019532728463
  • UPC 019348994368
  • UPC 019348937708
  • UPC 019348975763
  • UPC 019348947369
  • UPC 019532709400
  • UPC 019348949917
  • UPC 019532715339
  • UPC 019348971892
  • UPC 019348941589
  • UPC 088994297663
  • UPC 019532704649
  • UPC 019532724820
  • UPC 088827792129
  • UPC 019348945985
  • UPC 019348982057
  • UPC 019348988393
  • UPC 019532701909
  • UPC 019348927121
  • UPC 019348978423
  • UPC 019348983924
  • UPC 019348992493
  • UPC 019348992612
  • UPC 019532726241
  • UPC 019532717650
  • UPC 019348941383
  • UPC 088994227421
  • UPC 019532724489
  • UPC 019532724490
  • UPC 019348931923
  • UPC 019532724096
  • UPC 019348967442
  • UPC 019348938515
  • UPC 019532711641
  • UPC 019532724129
  • UPC 019348965872
  • UPC 019532704635
  • UPC 019348947918
  • UPC 019348963877
  • UPC 019348920945
  • UPC 019532724067
  • UPC 019532700259
  • UPC 019348926872
  • UPC 019532709387
  • UPC 019532721185
  • UPC 088994212967
  • UPC 019348971314
  • UPC 019348942584
  • UPC 019348926426
  • UPC 019348941786
  • UPC 019348928963
  • UPC 019348963423
  • UPC 019532711766
  • UPC 019348989982
  • UPC 019348945421
  • UPC 019532714092
  • UPC 019348957669
  • UPC 019348921181
  • UPC 019348952766
  • UPC 019532703927
  • UPC 019348981669
  • UPC 019532702146
  • UPC 019348929999
  • UPC 019532712835
  • UPC 019532708832
  • UPC 019348949162
  • UPC 019532702036
  • UPC 019532732286
  • UPC 019348936735
  • UPC 019532731504
  • UPC 019348926312
  • UPC 019532703329
  • UPC 019532722220
  • UPC 019532729331
  • UPC 019532722211
  • UPC 088994221921
  • UPC 019348999322
  • UPC 019348997955
  • UPC 019348999413
  • UPC 019532704243
  • UPC 019532707449
  • UPC 019532722292
  • UPC 019348923136
  • UPC 019348945094
  • UPC 019348943924
  • UPC 019348983381
  • UPC 019532708831
  • UPC 019348952003
  • UPC 019532701206
  • UPC 019348983858
  • UPC 019348988394
  • UPC 019532700015
  • UPC 019348981281
  • UPC 019348962640
  • UPC 019348996186
  • UPC 019532716563
  • UPC 019532717651
  • UPC 019348968528
  • UPC 019348948908
  • UPC 019348936944
  • UPC 019532709613
  • UPC 019348947953
  • UPC 019348926126
  • UPC 019348999431
  • UPC 019532724695
  • UPC 019532727643
  • UPC 019348990229
  • UPC 019532703624
  • UPC 019348946612
  • UPC 019532736012
  • UPC 019348947065
  • UPC 019348927823
  • UPC 019532722831
  • UPC 019348955285
  • UPC 088827773796
  • UPC 019532723552
  • UPC 019348984372
  • UPC 088827777034
  • UPC 019348948463
  • UPC 019348990224
  • UPC 019532714621
  • UPC 019348987340
  • UPC 019532717419
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 9,894 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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An example nursing home

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.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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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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