Procedural Kits Containing Ultrasound Gel Recalled for Sterility Concerns
Medline Industries is recalling 130 custom procedural kits containing ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 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 an FDA Class II medical device recall involving a potential sterility failure with no reported illnesses or injuries. Per the severity rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3. Non-sterile medical device components present a risk of serious infection.
Plain-English summary
Medline Industries, LP is recalling 130 custom sterile and non-sterile procedural kits that contain Turkuaz Ultrasound Gel. The affected product is Model DYNJ905655A (UPC 019348992579). The recall is due to a potential sterility failure in the ultrasound gel component contained within these kits, which may not meet required sterility specifications.
These procedural kits were distributed worldwide, including throughout the United States and to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. All lot numbers of this model distributed between April 1, 2020 and April 28, 2023 are affected.
Non-sterile components in medical procedural kits could pose a risk of infection if used. Healthcare facilities and providers who have received these kits should stop use and contact Medline Industries for return and replacement instructions.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. LIVER 2018, Model Number: DYNJ905655A;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Affected units
- 130
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: 019348992579.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 50 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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