Medline procedural kits recalled for ultrasound gel sterility defect
Medline recalls 100,549 procedural kits because the sterile ultrasound gel component may not meet sterility specifications. No illnesses or injuries have been reported.
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 recall for a potential sterility defect in a medical device component used in invasive procedures. With no reported illnesses or injuries and the hazard being theoretical, the maximum score per the rubric is 3.
Plain-English summary
Medline Industries, LP is recalling 100,549 custom sterile and non-sterile procedural kits distributed between April 1, 2020 and April 28, 2023. The recalled products are labeled as various vascular procedure packs and related kits, each containing Turkuaz Ultrasound Gel.
The recall was issued because the sterile ultrasound gel component within the kits may not meet sterility specifications. No illnesses or injuries have been reported in connection with this recall.
The recalled kits were distributed worldwide to the United States and international locations including Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. Consumers who have received these products should discontinue use and contact Medline Industries for replacement or return.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 100,549
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 (20)
- UPC Number: 019348956435
- Model Number: DYNJ22350L
- UPC Number: 019348944525
- Model Number: DYNJ22676J
- Model Number: DYNJ23445F
- UPC Number: 019532715035
- Model Number: DYNJ31902L
- Model Number: DYNJ31902M
- UPC Number: 019532729658
- Model Number: DYNJ39432I
- UPC Number: 019348933454
- Model Number: DYNJ39432J
- UPC Number: 019532710115
- Model Number: DYNJ39432K
- UPC Number: 019532730509
- Model Number: DYNJ41625B
- UPC Number: 088994293420
- Model Number: DYNJ46246A
- UPC Number: 088994258496
- Model Number: DYNJ53438A
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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