Class II FDA device recall · Z-2301-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was recalled

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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: 019532700730.  r. Model Number: DYNJ25749S, UPC Number: 019532705970.  s. Model Number: DYNJ47645C, UPC Number: 019532735517.  t. Model Number: DYNJ59392D, UPC Number: 019532705357; Model Number: DYNJ59392F, UPC Number: 019532713598.  u. Model Number: DYNJ67770, UPC Number: 019348943071.  v. Model Number: DYNJ23456K, UPC Number: 019348996776; Model Number: DYNJ68019, UPC Number: 019348946784; Model Number: DYNJ81716, UPC Number: 019532713806;  Model Number: DYNJ81716A, UPC Number: 019532720385; Model Number: DYNJ81716B, UPC Number: 019532727726.  w. Model Number: DYNJ67771, UPC Number: 019348943072.  x. Model Number: DYNJ31928D, UPC Number: 019532733528.  y. Model Number: DYNJ53480F, UPC Number: 019348942488.  z. Model Number: DYNJ67487C, UPC Number: 019532726074.  aa. Model Number: DYNJ82711, UPC Number: 019532720362.  bb. Model Number: DYNJ69943A, UPC Number: 019532728463.  cc. Model Number: DYNJ907915, UPC Number: 019348994368.  dd. Model Number: CDS984193O, UPC Number: 019348937708.  ee. Model Number: DYNJ46590I, UPC Number: 019348975763; Model Number: DYNJ46590J, UPC Number: 019348947369; Model Number: DYNJ46590K, UPC Number: 019532709400.  ff. Model Number: DYNJ68198, UPC Number: 019348949917.  gg. Model Number: DYNJ51925F, UPC Number: 019532715339.  hh. Model Number: DYNJ0541930N, UPC Number: 019348971892.   ii. Model Number: DYNJ64877B, UPC Number: 019348941589.   jj. Model Number: DYNJ55528A, UPC Number: 088994297663; Model Number: DYNJ55528B, UPC Number: 019532704649; Model Number: DYNJ55528C, UPC Number: 019532724820.  kk. Model Number: DYNJ48424A, UPC Number: 088827792129.  ll. Model Number: DYNJ58365C, UPC Number: 019348945985; Model Number: DYNJ58365F, UPC Number: 019348982057; Model Number: DYNJ58365G, UPC Number: 019348988393; Model Number: DYNJ58365J, UPC Number: 019532701909.  mm. Model Number: DYNJ62851B, UPC Number: 019348927121.  nn. Model Number: DYNJ62850A, UPC Number: 019348978423.  oo. Model Number: DYNJ905495D, UPC Number: 019348983924; Model Number: DYNJ905495F, UPC Number: 019348992493.  pp. Model Number: DYNJ38756B, UPC Number: 019348956435.  qq. Model Number: DYNJ907571A, UPC Number: 019348992612; Model Number: DYNJ907571B, UPC Number: 019532726241.  rr. Model Number: DYNJ40215C, UPC Number: 019532717650.  ss. Model Number: DYNJ52756A, UPC Number: 019348941383.   tt. Model Number: DYNJ47138B, UPC Number: 088994227421.  uu. Model Number: DYNJ82858A, UPC Number: 019532724489.  vv. Model Number: DYNJ82859A, UPC Number: 019532724490.  ww. Model Number: DYNJ66076, UPC Number: 019348931923.  xx. Model Number: DYKMBNDL22C, UPC Number: 019532724096.  yy. Model Number: CDS840487G, UPC Number: 019348967442.  zz. Model Number: DYNJ907262, UPC Number: 019348938515, Model Number: DYNJ907262B, UPC Number: 019532711641.  aaa. Model Number: DYKMBNDL148A, UPC Number: 019532724129.  bbb. Model Number: DYNJ906113, UPC Number: 019348965872.  ccc. Model Number: DYNJ906086B, UPC Number: 019532704635.  ddd. Model Number: DYKMBNDL23, UPC Number: 019348947918.  eee. Model Number: DYNJ906098, UPC Number: 019348963877; Model Number: DYNJ906098A, UPC Number: 019348920945.  fff. Model Number: DYKMBNDL118A, UPC Number: 019532724067.  ggg. Model Number: DYNJ906960A, UPC Number: 019532700259.  hhh.  Model Number: DYNJ56283C, UPC Number: 019348926872; Model Number: DYNJ56283D, UPC Number: 019532709387; Model Number: DYNJ56283F, UPC Number: 019532721185.  iii. Model Number: DYNJ48962B, UPC Number: 088994212967.  jjj. Model Number: DYNJ38995C, UPC Number: 019348971314, Model Number: DYNJ67725, UPC Number: 019348942584.   kkk. Model Number: DYNJ65294, UPC Number: 019348926426.  lll. Model Number: DYNJ905859B, UPC Number: 019348941786.  mmm. Model Number: DYNJ54906B, UPC Number: 019348928963.  nnn. Model Number: DYNJ905626B, UPC Number: 019348963423.  ooo. Model Number: DYNJ81407, UPC Number: 019532711766.  ppp. Model Number: DYNJ41100C, UPC Number: 019348989982.  qqq. Model Number: DYNJ0678934G, UPC Number: 019348956435.  rrr. Model Number: DYNJ902168C, UPC Number: 019348945421.    sss. Model Number: DYNJ908687, UPC Number: 019532714092.  ttt. Model Number: DYNJ61373, UPC Number: 019348957669.  uuu. Model Number: DYNJ901062D, UPC Number: 019348921181; Model Number: DYNJ905641, UPC Number: 019348952766; Model Number: DYNJ905641A, UPC Number: 019532703927; Model Number: DYNJ906371B, UPC Number: 019348981669; Model Number: DYNJ906371C, UPC Number: 019532702146; Model Number: DYNJ906951, UPC Number: 019348929999; Model Number: DYNJ906951A, UPC Number: 019532712835; Model Number: DYNJ908390, UPC Number: 019532708832.  vvv. Model Number: CDS840368M, UPC Number: 019348949162; Model Number: CDS840368N, UPC Number: 019532702036; Model Number: CDS840368P, UPC Number: 019532732286.  www. Model Number: DYNJ45515D, UPC Number: 019348936735; Model Number: DYNJ81610A, UPC Number: 019532731504.  xxx. Model Number: DYNJC9307F, UPC Number: 019348926312; Model Number: DYNJC9307G, UPC Number: 019532703329.  yyy. Model Number: DYNJ82988, UPC Number: 019532722220; Model Number: DYNJ82988A, UPC Number: 019532729331.  zzz. Model Number: DYNJ82987, UPC Number: 019532722211.   aaaa. Model Number: DYNJ0622403O, UPC Number: 088994221921.   bbbb. Model Number: DYNJ66916A, UPC Number: 019348999322.   cccc. Model Number: DYNJ903705I, UPC Number: 019348997955.   dddd. Model Number: DYNJ903706K, UPC Number: 019348999413.   eeee. Model Number: DYNJ53433G, UPC Number: 019532704243; Model Number: DYNJ53433I, UPC Number: 019532707449; Model Number: DYNJ53433J, UPC Number: 019532722292.   ffff. Model Number: DYNJ44122B, UPC Number: 019348923136.   gggg.Model Number: DYNJ904171D, UPC Number: 019348945094; Model Number: DYNJ904171F, UPC Number: 019348943924; Model Number: DYNJ907063A, UPC Number: 019348983381; Model Number: DYNJ908391, UPC Number: 019532708831.   hhhh. Model Number: DYNJ60713, UPC Number: 019348952003; Model Number: DYNJ60713A, UPC Number: 019532701206; Model Number: DYNJ68616, UPC Number: 019348983858; Model Number: DYNJ69036, UPC Number: 019348988394.   iiii. Model Number: DYNJ0349727D, UPC Number: 019532700015.   jjjj. Model Number: DYNJ31148I, UPC Number: 019348956435.   kkkk. Model Number: DYNJ61584A, UPC Number: 019348981281.   llll. Model Number: CDS984231T, UPC Number: 019348962640.   mmmm. Model Number: CDS984241L, UPC Number: 019348996186; Model Number: CDS984241M, UPC Number: 019532716563.   nnnn. Model Number: DYNJ63892A, UPC Number: 019532717651.   oooo. Model Number: DYNJ62735, UPC Number: 019348968528.   pppp. Model Number: 00-401185Q, UPC Number: 019348948908.   qqqq. Model Number: DYNJ52056C, UPC Number: 019348936944; Model Number: DYNJ52056D, UPC Number: 019532709613.   rrrr. Model Number: DYNJ904261B, UPC Number: 019348947953; Model Number: DYNJ905311D, UPC Number: 019348926126; Model Number: DYNJ906760C, UPC Number: 019348999431; Model Number: DYNJ906760D, UPC Number: 019532724695; Model Number: DYNJ9718008AS, UPC Number: 019348926312; Model Number: CDS981161AC, UPC Number: 019532727643.     ssss. Model Number: CDS985105N, UPC Number: 019348990229; Model Number: CDS985105O, UPC Number: 019532703624.   tttt. Model Number: DYNJ0450131AI, UPC Number: 019348946612.   uuuu. Model Number: DYNJ20888K, UPC Number: 019532736012.   vvvv. Model Number: DYNJ23533B, UPC Number: 019348956435; Model Number: DYNJ23533D, UPC Number: 019348947065.   wwww. Model Number: CDS983849D, UPC Number: 019348927823, Model Number: CDS983849F, UPC Number: 019532722831.   xxxx. Model Number: DYNJ55836A, UPC Number: 019348955285.   yyyy. Model Number: DYNJ0149567B, UPC Number: 088827773796; Model Number: DYNJ0149567C, UPC Number: 019532723552.   zzzz. Model Number: CDS983513F, UPC Number: 019348984372; Model Number: CDS984355F, UPC Number: 088827777034; Model Number: CDS984355G, UPC Number: 019348948463; Model Number: DYNJ905311F, UPC Number: 019348990224; Model Number: DYNJ905311I, UPC Number: 019532714621; Model Number: DYNJ907607A, UPC Number: 019348987340; Model Number: DYNJ907607B, UPC Number: 019532717419.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-2301-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2023-05-15

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2301-2023 · Source: openFDA enforcement.