Custom Procedural Kits May Contain Non-Sterile Ultrasound Gel
Medline is recalling sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications. Approximately 6,939 kits were distributed between April 2020 and 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: This is a Class II recall of sterile medical device components where the labeled sterile gel may not meet sterility specifications. Per the rubric, this qualifies as a high-risk product where injury has not yet been reported, warranting a score of 3.
Plain-English summary
Medline Industries, LP is recalling custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel. The recalled products include central catheter insertion trays (Model CVI680C), CVC insertion accessory kits (Model ECVC7880), CVL insertion trays (Model DYNDC1786A), ultrasound-guided PIV insertion kits (Model IVS3635B), and USG PIV insertion kits (Model DYNDV2480A). Approximately 6,939 kits are affected.
The sterile ultrasound gel component within these kits may not meet sterility specifications. The affected kits were distributed between April 1, 2020, and April 28, 2023.
The recalled kits were distributed worldwide to healthcare facilities and distributors in the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
Healthcare facilities that received these kits should cease use immediately and contact Medline Industries for further instructions regarding the affected lot numbers.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCESSORY KIT, Model Number: ECVC7880; c. CVL INSERTION TRAY, Model Number: DYNDC
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kit
- Hazard
- sterility-failure
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 (5)
- UPC Number: 065316099294. b. Model Number: ECVC7880
- UPC Number: 019532712961. c. Model Number: DYNDC1786A
- UPC Number: 019348919911. d. Model Number: IVS3635B
- UPC Number: 019348936055. e. Model Number: DYNDV2480A
- UPC Number: 019532732721.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03