Agency classClass IIOur severity:High FDA (Devices)·Z-2190-2023·Announced 2023-07-26

Medline ultrasound probe cover kits recalled for inadequate seam barriers

Medline probe cover kits used in diagnostic ultrasound procedures may have inadequate barriers at the seams. The recall affects 540 units distributed worldwide between December 2017 and May 2023.

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: FDA Class II recall with no reported illnesses or injuries. The hazard—inadequate seam barriers in sterile probe covers—represents a risk-of-harm medical device where injury has not yet been reported, meeting the criteria for High severity.

Plain-English summary

Medline Industries is recalling probe cover kits containing sterile ultrasound gel, labeled as CATH LAB PACK with Model Number DYNJ58351A, used during diagnostic ultrasound procedures. The probe covers may have an inadequate barrier at the seams.

The recall affects 540 units distributed worldwide between December 2017 and May 2023. Distribution includes the United States and the following countries: United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. The affected products can be identified by Model Number DYNJ58351A and the UDI/DI codes: UDI/DI (EA) 10888277739390 and UDI/DI (CS) 40888277739391.

An inadequate seam barrier in a sterile medical device used in diagnostic procedures may compromise the intended sterile barrier function during ultrasound examinations.

The recalled product

Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYNJ58351A
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Ultrasound probe covers
Hazard: inadequate-barrier
contamination-risk
Affected units: 540

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 (3)

all lots within expiry
UDI/DI (EA) 10888277739390
UDI/DI (CS) 40888277739391

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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