Ultrasound Gel in Medline Procedural Kits Recalled Over Sterility Specification Concerns
Medline Industries recalled approximately 154,900 Custom Sterile and Non-Sterile Procedural Kits worldwide because the sterile ultrasound gel component may not meet sterility specifications.
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: No illnesses or injuries are reported, and the hazard is theoretical—the gel may not meet sterility specifications. Per the rubric, Class II recalls with theoretical hazards and no reported adverse health consequences are scored at level 3 (High).
Plain-English summary
Medline Industries, LP is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel (model DYNDA1219). Approximately 154,900 kits were distributed worldwide between April 1, 2020, and April 28, 2023.
The labeled sterile ultrasound gel component within the kits may not meet FDA sterility specifications. The distribution included the United States and Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROBE COVER PACK, Model Number: DYNDA1219
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 154,900
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: 10888277283879.
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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