Agency classClass IIOur severity:High FDA (Devices)·Z-2290-2023·Announced 2023-08-09

Medline Probe Cover Kits recalled for potential sterility specification failure

Medline is recalling 1,231,480 Probe Cover Kits distributed worldwide due to potential sterility specification failures in the ultrasound gel component.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FDA Class II recall involves a sterile medical device with potential specification failures. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High (3) severity rating.

Plain-English summary

Medline Industries, LP is recalling Probe Cover Kits containing Turkuaz Ultrasound Gel in six model configurations (DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, and DYNJEX5900). The recalled quantity is 1,231,480 kits.

The labeled sterile ultrasound gel component in these kits has the potential to not meet sterility specifications. The affected kits were distributed worldwide, including throughout the US and to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.

Healthcare facilities and individuals with affected kits should consult the FDA recall notice for specific lot numbers and contact Medline Industries for instructions regarding affected inventory.

The recalled product

Product: Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model…
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Ultrasound Probe Covers
Hazard: sterility-failure
non-sterile
Affected units: 1,231,480

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)

a. Model Number DYNJE5900
UDI-DI Each: 10884389114124
Case: 40884389114125
Lot Numbers: 06920030012
06920030021
06920040022
06920050011
06920070011
06920080012
06920100011
06920110011
06920120011
06921010011
06921010022
06921020011
06921020021
06921030021
06921030031
06921040011
06921050011

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 50 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 50 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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