Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers
Medline is recalling 2,304 probe cover kits because the seams may not provide adequate barrier protection during ultrasound procedures. Affected kits 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: FDA Class II recall with no reported illnesses or injuries. The hazard—inadequate seam barriers in ultrasound probe covers—presents a theoretical risk of patient exposure to contamination during diagnostic procedures.
Plain-English summary
Medline Industries is recalling Probe Cover Kits containing sterile Ultrasound Gel (labeled as CATH LAB BASIN PACK, Model Number DYNJ69864A) because the probe covers may have inadequate barrier protection at the seams.
These probe covers are used during diagnostic ultrasound procedures. An inadequate barrier at the seams could compromise the protective seal, potentially exposing patients to contamination during the procedure.
Approximately 2,304 units were distributed worldwide between December 2017 and May 2023 to facilities in the United States and internationally. Customers who have received these kits should discontinue use and contact Medline Industries for return or replacement information.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB BASIN PACK, Model Number DYNJ69864A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 2,304
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) 10195327132057
- UDI/DI (CS) 40195327132058
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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