MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2162-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATH PACK, Model Number DYNJ83105; b) TESIO, Model Number DYNJ83251; c) ANGIOGRAPHY PACK-LF, Model Number DYNJ83508; d) OR ANGIOGRAM PACK-LF, Model Number DYNJ83656; e) FERRELL-DUCAN ANGIO, Model Number DYNJ83696; f) ANGIO KIT PACK, Model Number DYNJ83746; g) M&E ARTERIOGRAM PK, Model Number DYNJ83815; h) ANGIOGRAPHY CV RAD PACK, Model Number DYNJ83918; i) ANGIO PACK, Model Number DYNJ83936; j) ARTERIOGRAM - SUMMIT PACK, Model Number DYNJ84040; k) ANGIO PACK, Model Number DYNJ84190; l) ANGIO, Model Number DYNJ902507C; m) ANGIO, Model Number DYNJ902507D; n) ANGIO, Model Number DYNJ905151B; o) PACK ANGIOPLASTY CV,8405, Model Number DYNJ906766B; p) (13) STC IVC FILTER/ANGIOGRAM, Model Number DYNJ908249A; q) OR ANGIOGRAM, Model Number DYNJ909267; r) RADIOLOGY PACK #108402-LF, Model Number DYNJVB1000; s) HYBRID OR PACK, Model Number SYNJ10303C

Product Classification:

Class II

Date Initiated: May 18, 2023

Date Posted: July 26, 2023

Recall Number: Z-2162-2023

Event ID: 92466

Reason for Recall:

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

Status: Ongoing

Product Quantity: # included in 3,740,814 units total

Code Information:

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ83105, UDI/DI (EA)10195327231514, UDI/DI (CS)40195327231515; b) Model Number DYNJ83251, UDI/DI (EA)10195327248659, UDI/DI (CS)40195327248650; c) Model Number DYNJ83508, UDI/DI (EA)10195327273163, UDI/DI (CS)40195327273164; d) Model Number DYNJ83656, UDI/DI (EA)10195327288228, UDI/DI (CS)40195327288229; e) Model Number DYNJ83696, UDI/DI (EA)10195327299125, UDI/DI (CS)40195327299126; f) Model Number DYNJ83746, UDI/DI (EA)10195327300692, UDI/DI (CS)40195327300693; g) Model Number DYNJ83815, UDI/DI (EA)10195327311018, UDI/DI (CS)40195327311019; h) Model Number DYNJ83918, UDI/DI (EA)10195327313807, UDI/DI (CS)40195327313808; i) Model Number DYNJ83936, UDI/DI (EA)10195327318550, UDI/DI (CS)40195327318551; j) Model Number DYNJ84040, UDI/DI (EA)10195327329709, UDI/DI (CS)40195327329700; k) Model Number DYNJ84190, UDI/DI (EA)10195327341961, UDI/DI (CS)40195327341962; l) Model Number DYNJ902507C, UDI/DI (EA)10195327137885, UDI/DI (CS)40195327137886; m) Model Number DYNJ902507D, UDI/DI (EA)10195327336561, UDI/DI (CS)40195327336562; n) Model Number DYNJ905151B, UDI/DI (EA)10195327219963, UDI/DI (CS)40195327219964; o) Model Number DYNJ906766B, UDI/DI (EA)10195327250195, UDI/DI (CS)40195327250196; p) Model Number DYNJ908249A, UDI/DI (EA)10195327240509, UDI/DI (CS)40195327240500; q) Model Number DYNJ909267, UDI/DI (EA)10195327314613, UDI/DI (CS)40195327314614; r) Model Number DYNJVB1000, UDI/DI (EA)10193489800999, UDI/DI (CS)40193489800990; s) Model Number SYNJ10303C, UDI/DI (EA)10195327118891, UDI/DI (CS)40195327118892

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated