Class II FDA device recall · Z-2186-2023

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.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G; b) DBS PACK-LF, Model Number DYNJ0878178J; c) DBS PACK-LF, Model Number DYNJ0878178K; d) NEURO ARTERIOGRAM PACK-LF, Model Number DYNJ0948060F; e) NEURO IR PACK, Model Number DYNJ35066I; f) NEURO IR PACK, Model Number DYNJ35066J; g) IR NEURO PACK, Model Number DYNJ39198L; h) IR NEURO PACK, Model Number DYNJ39198N; i) BASIC PACK, Model Number DYNJ39752A; j) C.I.C.N. ANGIO PACK, Model Number DYNJ53064B; k) ANGIOGRAPHIC PACK, Model Number DYNJ57442C; l) ANGIO/VENO PACK, Model Number DYNJ58346A; m) NEURO RADIOLOGY PACK, Model Number DYNJ59903A; n) NEURO RADIOLOGY PACK, Model Number DYNJ59903B; o) PACK PERCUTANEOUS ANGIO CHRG, Model Number DYNJ60112A; p) NEURO IR PACK, Model Number DYNJ60701D; q) RADIOLOGY NEURO DRAPE PAC, Model Number DYNJ61449; r) NEURO PACK, Model Number DYNJ61798D; s) BASIC CATH/ANGIO, Model Number DYNJ62591A; t) ANGIOGRAPHIC PACK, Model Number DYNJ64081A; u) ANGIO PACK, Model Number DYNJ64676; v) ANGIOGRAPHY PACK, Model Number DYNJ65963; w) NEURO PACK, Model Number DYNJ66241A; x) NEURO PACK, Model Number DYNJ66241B; y) NEURO PACK, Model Number DYNJ66241C; z) NEURO PACK, Model Number DYNJ66241D; aa) NEURO ACCESSORY PACK, Model Number DYNJ66790A; bb) NEURO ACCESSORY PACK, Model Number DYNJ66790B; cc) NEURO TRAY, Model Number DYNJ67075A; dd) NEURO PACK, Model Number DYNJ68956A; ee) NEURO PACK, Model Number DYNJ68956B; ff) NEURO CATH PACK, Model Number DYNJ69129; gg) NEURO CATH PACK, Model Number DYNJ83090; hh) ANGIO, Model Number DYNJ905151A; ii) KIT OR AORTOGRM ANGIOPLAST PHT, Model Number DYNJ906086A; jj) ARTHROGRAM TRAY, Model Number SPEC0232

Why it was recalled

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

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 lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Number DYNJ0429121G, UDI/DI (EA) 10193489711554, UDI/DI (CS) 40193489711555;  b) Model Number DYNJ0878178J, UDI/DI (EA) 10193489914368, UDI/DI (CS) 40193489914369;  c) Model Number DYNJ0878178K, UDI/DI (EA) 10195327328788, UDI/DI (CS) 40195327328789;  d) Model Number DYNJ0948060F, UDI/DI (EA) 10889942825103, UDI/DI (CS) 40889942825104;  e) Model Number DYNJ35066I, UDI/DI (EA) 10193489262292, UDI/DI (CS) 40193489262293;  f) Model Number DYNJ35066J, UDI/DI (EA) 10195327091071, UDI/DI (CS) 40195327091072;  g) Model Number DYNJ39198L, UDI/DI (EA) 10193489262919, UDI/DI (CS) 40193489262910;  h) Model Number DYNJ39198N, UDI/DI (EA) 10195327102005, UDI/DI (CS) 40195327102006;  i) Model Number DYNJ39752A, UDI/DI (EA) 10884389907238, UDI/DI (CS) 40884389907239;  j) Model Number DYNJ53064B, UDI/DI (EA) 10193489789164, UDI/DI (CS) 40193489789165;  k) Model Number DYNJ57442C, UDI/DI (EA) 10193489208535, UDI/DI (CS) 40193489208536;  l) Model Number DYNJ58346A, UDI/DI (EA) 10193489774634, UDI/DI (CS) 40193489774635;  m) Model Number DYNJ59903A, UDI/DI (EA) 10195327042868, UDI/DI (CS) 40195327042869;  n) Model Number DYNJ59903B, UDI/DI (EA) 10195327131203, UDI/DI (CS) 40195327131204;  o) Model Number DYNJ60112A, UDI/DI (EA) 10193489247039, UDI/DI (CS) 40193489247030;  p) Model Number DYNJ60701D, UDI/DI (EA) 10195327383312, UDI/DI (CS) 40195327383313;  q) Model Number DYNJ61449, UDI/DI (EA) 10193489567342, UDI/DI (CS) 40193489567343;  r) Model Number DYNJ61798D, UDI/DI (EA) 10193489992632, UDI/DI (CS) 40193489992633;  s) Model Number DYNJ62591A, UDI/DI (EA) 10193489793314, UDI/DI (CS) 40193489793315;  t) Model Number DYNJ64081A, UDI/DI (EA) 10193489273748, UDI/DI (CS) 40193489273749;  u) Model Number DYNJ64676, UDI/DI (EA) 10193489214383, UDI/DI (CS) 40193489214384;  v) Model Number DYNJ65963, UDI/DI (EA) 10193489307702, UDI/DI (CS) 40193489307703;  w) Model Number DYNJ66241A, UDI/DI (EA) 10193489938036, UDI/DI (CS) 40193489938037;  x) Model Number DYNJ66241B, UDI/DI (EA) 10195327053482, UDI/DI (CS) 40195327053483;  y) Model Number DYNJ66241C, UDI/DI (EA) 10195327096854, UDI/DI (CS) 40195327096855;  z) Model Number DYNJ66241D, UDI/DI (EA) 10195327138370, UDI/DI (CS) 40195327138371;  aa) Model Number DYNJ66790A, UDI/DI (EA) 10193489922479, UDI/DI (CS) 40193489922470;  bb) Model Number DYNJ66790B, UDI/DI (EA) 10195327099268, UDI/DI (CS) 40195327099269;  cc) Model Number DYNJ67075A, UDI/DI (EA) 10195327054533, UDI/DI (CS) 40195327054534;  dd) Model Number DYNJ68956A, UDI/DI (EA) 10193489876291, UDI/DI (CS) 40193489876292;  ee) Model Number DYNJ68956B, UDI/DI (EA) 10195327094348, UDI/DI (CS) 40195327094349;  ff) Model Number DYNJ69129, UDI/DI (EA) 10193489892413, UDI/DI (CS) 40193489892414;  gg) Model Number DYNJ83090, UDI/DI (EA) 10195327230937, UDI/DI (CS) 40195327230938;  hh) Model Number DYNJ905151A, UDI/DI (EA) 10193489813418, UDI/DI (CS) 40193489813419;  ii) Model Number DYNJ906086A, UDI/DI (EA) 10193489208689, UDI/DI (CS) 40193489208680;  jj) Model Number SPEC0232, UDI/DI (EA) 10888277507418, UDI/DI (CS) 40888277507419

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-2186-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2023-05-18

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-2186-2023 · Source: openFDA enforcement.