Recall archive / FDA device enforcement
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, ... — FDA record Z-2186-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 18, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 14848 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2186-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 26, 2023
- Recall initiation date
- May 18, 2023
- Center classification date
- Jul 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.