Medline Probe Cover Kits Recalled Due to Inadequate Seam Barriers
Medline is recalling Probe Cover Kits because probe covers may have inadequate seam barriers that could allow contamination during ultrasound procedures. Approximately 24,192 units were distributed worldwide from December 2017 to 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: This is a medical device defect involving a compromised barrier function on a product designed to prevent contamination during diagnostic procedures. Although no illnesses or injuries have been reported, the inadequate seam barriers represent a risk-of-harm for potential infection, meeting the rubric criterion for High severity.
Plain-English summary
Medline Industries, LP is recalling Probe Cover Kits (Model DYND41472) containing sterile ultrasound gel due to inadequate barriers at the seams. These probe covers are used during diagnostic ultrasound procedures and are designed to provide a sterile barrier between the ultrasound probe and the patient.
The inadequate seam barriers could potentially allow contaminants to penetrate during ultrasound procedures. No illnesses or injuries have been reported in connection with this recall. Approximately 24,192 units have been distributed worldwide, including throughout the United States and internationally to the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.
Affected units include all lots distributed between December 2017 and May 2023 with Model Number DYND41472. Healthcare facilities that received these probe cover kits should stop using them immediately and contact Medline Industries for replacement products or disposal instructions. Patients who may have undergone ultrasound procedures with these probe covers should consult their healthcare provider with any concerns about their health.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 24,192
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) 10080196996537
- UDI/DI (CS) 40080196996538
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.
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