Medline Pediatric EP Pack Procedural Kits with Sterile Ultrasound Gel Defect
Medline is recalling pediatric electrophysiology procedural kits because the ultrasound gel component may not meet sterility specifications. The recall affects 192 kits distributed worldwide from April 2020 to 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: FDA Class II recall with a theoretical hazard (potential failure to meet sterility specifications) and no reported illnesses or injuries. Medical device used in sterile procedures presents risk of harm, but no actual patient harm has been documented.
Plain-English summary
Medline Industries is recalling Custom Sterile and Non-Sterile Procedural Kits labeled as PEDIATRIC EP PACK (Model Number DYNJ45158A) that contain Turkuaz Ultrasound Gel. The ultrasound gel component in these kits may not meet sterility specifications, which could compromise the sterile conditions required for pediatric electrophysiology procedures.
This recall affects 192 kits with Model Number DYNJ45158A and UPC Number 088827750721, with all lot numbers distributed between April 1, 2020, and April 28, 2023. The affected kits were distributed worldwide to the United States and internationally to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.
No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 192
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 (3)
- Model Number: DYNJ45158A
- UPC Number: 088827750721
- all lot numbers distributed from Medline between 04/01/2020 and 04/28/2023.
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.
See all 50 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · sterility defect
See all →- SevereLidocaine Hydrochloride Injection Recalled for Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereIMULDOSA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-08
- HighChloraPrep One-Step antiseptic solution sterility assurance recall
FDA (Drugs) · 2026-07-01
- ModerateCodman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin
FDA (Devices) · 2026-05-20
- SevereGenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
Similar recalls
- HighMedline Ultrasound Probe Cover Kits Recalled Due to Barrier Defect
FDA (Devices) · 2023-07-26
- HighMedline Ultrasound Probe Cover Kits Recalled for Inadequate Seams
FDA (Devices) · 2023-07-26
- HighMedline Ultrasound Probe Cover Kits Recalled for Inadequate Sterile Barrier
FDA (Devices) · 2023-07-26
- HighFDA Recalls Medline Probe Cover Kits Due to Seam Defects
FDA (Devices) · 2023-07-26
- HighMedline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier
FDA (Devices) · 2023-07-26
- HighMedline Probe Cover Kits Recalled for Inadequate Seam Barrier
FDA (Devices) · 2023-07-26