High FDA (Devices)·Z-2186-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

Medline is recalling 14,848 ultrasound probe cover kits due to potentially inadequate barriers at the seams. The kits were distributed worldwide between December 2017 and May 2023 for use in diagnostic procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of probe covers used in invasive diagnostic procedures where an inadequate seam barrier could allow contamination. No illnesses or injuries have been reported; the hazard is theoretical, consistent with a High severity classification for risk-of-harm products without reported harm.

Plain-English summary

Medline Industries, LP is recalling 14,848 ultrasound probe cover kits containing sterile gel due to potentially inadequate barriers at the seams. These kits were distributed worldwide between December 2017 and May 2023 for use in diagnostic ultrasound procedures, including angiography and neurology applications.

The affected products include multiple model numbers such as DBS Packs, Neuro Arteriogram Packs, Angiographic Packs, and others. Distribution included the United States and international locations including United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

Users of these products should verify their products against the model numbers and UDI codes provided on the FDA website, and discontinue use of any affected units. Contact Medline Industries or your healthcare provider for guidance on replacement or disposal.

The recalled product

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 Numbe
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Ultrasound / Diagnostic
Hazard: inadequate-barrier
contamination
Affected units: 14,848

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

all lots within expiry
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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 52 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 52 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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