Medline Ultrasound Probe Cover Kits Recalled Due to Barrier Defect
Medline is recalling Pediatric EP Pack ultrasound probe cover kits with sterile gel because the probe covers may have inadequate barriers at the seams, potentially compromising sterility during diagnostic procedures.
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 sterile barrier defect in medical device components used during diagnostic procedures, carrying inherent risk of contamination. FDA classified this as a Class II recall. However, no illnesses or injuries have been reported, making the hazard theoretical. Per the rubric, risk-of-harm products with no reported injury warrant a High severity rating.
Plain-English summary
Medline Industries is recalling Probe Cover Kits containing sterile Ultrasound Gel, model DYNJ45158A, labeled as PEDIATRIC EP PACK. The probe covers may have an inadequate barrier at the seams, which could compromise the sterile barrier during diagnostic ultrasound procedures.
The affected kits were distributed worldwide from December 2017 through May 2023. Distribution included the United States (nationwide) and international locations including the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. The recalled kits had UDI codes: UDI/DI (EA) 10888277507210 and UDI/DI (CS) 40888277507211.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 36
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 (2)
- all lots within expiry
- UDI/DI (CS) 40888277507211
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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