Medline procedural kits with potentially non-sterile ultrasound gel recalled
Medline Industries is recalling 80 custom procedural kits containing ultrasound gel that may not meet sterility specifications. Kits were distributed worldwide from April 2020 to April 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 recall of a risk-of-harm medical device with potential for patient contamination from non-sterile components. No illnesses or injuries are reported in the source material.
Plain-English summary
Medline Industries, LP has issued a Class II recall of custom sterile and non-sterile procedural kits (Model DYNJ60126B, UPC 019532711883) containing Turkuaz ultrasound gel. Approximately 80 kits were distributed worldwide between April 1, 2020 and April 28, 2023, including to the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
The recall was issued due to the potential for the sterile ultrasound gel component to not meet sterility specifications. Gel labeled as sterile may not actually be sterile, creating a risk of contamination or infection during medical procedures where these kits are used.
All lot numbers of the affected model (DYNJ60126B) that were distributed during the specified timeframe are included in this recall. Facilities or providers that may have received these kits should verify whether they possess any affected products and contact Medline Industries for further guidance on product replacement or return.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PACK ENDO AAA HYBRID CHRG, Model Number: DYNJ60126B;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-failure
- contamination-risk
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 (1)
- UPC Number: 019532711883.
Distribution
Distributed nationwide across the United States.
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