Medline Probe Cover Kits Recalled for Inadequate Seam Barriers
Medline is recalling 4,644 sterile ultrasound gel probe cover kits with potentially inadequate seams that could compromise barrier integrity during ultrasound procedures.
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 of medical device with seam barrier defect that creates risk of contamination during sterile ultrasound procedures. No illnesses or injuries reported; hazard is theoretical but presents risk of harm in clinical use.
Plain-English summary
Medline Industries, LP is recalling 4,644 sterile ultrasound gel probe cover kits distributed from December 2017 through May 2023. The recall affects four model kits: CVC PACK (Model DYNJ46967F), ENDOVENOUS CORE PACK (Model DYNJ62557), ENSEMBLE CATHETER DIALYSE-LF (Model DYNJ81973), and TVS4000 ENDOVENOUS PACK (Model TVS4000K).
The probe covers may have an inadequate barrier at the seams. This defect could allow contamination during ultrasound procedures when the covers are used to maintain sterile conditions.
The affected devices were distributed worldwide to the United States and internationally to United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.
Affected healthcare facilities and users should verify their inventory using the provided model numbers and UDI codes to identify recalled units.
The recalled product
- Product
- Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Affected units
- 4,644
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 (8)
- all lots within expiry
- UDI/DI (EA) 10193489576047UDI/DI (CS) 40193489576048
- b) Model Number DYNJ62557
- UDI/DI (EA) 10193489669152UDI/DI (CS) 40193489669153
- c) Model Number DYNJ81973
- UDI/DI (EA) 10195327204877UDI/DI (CS) 40195327204878
- d) Model Number TVS4000K
- UDI/DI (EA) 10816982023862UDI/DI (CS) 40816982023863
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 52 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 52 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 · barrier defect
See all →- HighUltrasound probe covers recalled over defects that may cause contamination during use
FDA (Devices) · 2026-01-07
- HighMedline Probe Cover Kits Recalled for Inadequate Seam Barriers
FDA (Devices) · 2023-07-26
- HighMedline Ultrasound Probe Covers Recalled for Seam Barrier Defects
FDA (Devices) · 2023-07-26
- HighMedline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers
FDA (Devices) · 2023-07-26
- HighMedline ultrasound probe covers recalled for inadequate seam barrier
FDA (Devices) · 2023-07-26
Similar recalls
- HighMedline Probe Cover Kits recalled for potential sterility specification failure
FDA (Devices) · 2023-08-09
- HighMedline Procedural Kits Recalled for Potential Sterility Failure in Ultrasound Gel
FDA (Devices) · 2023-08-09
- HighMedline Procedural Kits Recalled for Ultrasound Gel Sterility Defect
FDA (Devices) · 2023-08-09
- HighMedline sterile procedural kits recalled for potentially non-sterile gel
FDA (Devices) · 2023-08-09
- HighMedline Procedural Kits Recalled Due to Potential Sterility Specification Failures
FDA (Devices) · 2023-08-09
- HighMedline Medical Procedural Kits Recalled for Potential Ultrasound Gel Sterility Failure
FDA (Devices) · 2023-08-09