The Recall Desk
HighFDA (Devices)·Z-2188-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers

Medline Industries is recalling ultrasound probe cover kits due to inadequate barriers at the seams. The defect may allow contaminants to reach the patient during diagnostic ultrasound 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: FDA Class II medical device with a functional defect (inadequate seam barrier) creating a theoretical risk of contamination during diagnostic procedures. As a risk-of-harm product without reported illnesses or injuries, this fits the High severity category.

Plain-English summary

Medline Industries, LP is recalling Medline Probe Cover Kits containing sterile ultrasound gel, Model Number DYNJ902540N. The recall was issued because the probe covers may have an inadequate barrier at the seams, which could allow fluid or other contaminants to reach the patient's skin during diagnostic ultrasound procedures.

The affected product consists of 78 units that were distributed worldwide from December 2017 through May 2023. Distribution includes the United States as well as facilities in the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

Patients or healthcare facilities who have received or used these probe cover kits should contact Medline Industries for product replacement or additional guidance.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model Number DYNJ902540N
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound / Diagnostic
Hazard
Affected units
78

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) 10193489916669
  • UDI/DI (CS) 40193489916660

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 →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · seam defect

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