Medline Ultrasound Probe Cover Kits recalled for inadequate seam barrier
Medline is recalling Probe Cover Kits that may have inadequate barrier at the seams, potentially compromising sterility during diagnostic ultrasound procedures. The recall affects kits distributed worldwide from December 2017 through May 2023.
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 recall with no reported illnesses or injuries. The hazard—inadequate seam barrier in probe covers—poses a potential risk to patient safety during diagnostic ultrasound procedures, but the risk remains theoretical with no documented adverse events.
Plain-English summary
Medline Industries is recalling Probe Cover Kits (Model DYNJ61476, labeled ANESTHESIA OH TOTE) that contain sterile Ultrasound Gel. The recalled kits consist of 100 units per order.
The probe covers in these kits may have an inadequate barrier at the seams. This defect could compromise the sterility or isolation properties of the ultrasound gel during diagnostic ultrasound procedures.
The affected kits were distributed worldwide between December 2017 and May 2023 to facilities in the United States, United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. All affected lots remain within their expiration dates.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ANESTHESIA OH TOTE, Model Number DYNJ61476
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 100
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) 40193489571999
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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