The Recall Desk
HighFDA (Devices)·Z-2164-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

Medline is recalling ultrasound probe cover kits containing sterile gel due to inadequate barriers at the seams, which may fail to maintain sterility during diagnostic procedures.

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 an FDA Class II recall of sterile medical device components with an identified product defect—inadequate seam barriers—that poses a risk of contamination during invasive diagnostic procedures. No injuries or illnesses have been reported; the hazard represents a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling ultrasound probe cover kits with sterile gel used during diagnostic ultrasound procedures. The recalled kits may have inadequate barriers at the seams, which could compromise sterility during use.

The affected kits include multiple model numbers distributed from December 2017 through May 2023, representing 3,740,814 units total. Distribution included the United States and international locations: United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

Healthcare providers should immediately discontinue use of the affected probe cover kits. Customers should check their inventory against the model numbers and UDI codes listed in the FDA recall notice. Contact Medline Industries for replacement or credit. No injuries or illnesses have been reported.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A; c) SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B; d) VEIN PACK, Model Number DY
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Diagnostic Ultrasound Equipment
Hazard
  • barrier-failure
  • contamination-risk

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)

  • all lots within expiry
  • UDI/DI (EA)10195327339487
  • UDI/DI (CS)40195327339488
  • b) Model Numbers DYNJ53616A
  • UDI/DI (EA)10889942688562
  • UDI/DI (CS)40889942688563
  • c) Model Numbers DYNJ54014B
  • UDI/DI (EA)10889942760329
  • UDI/DI (CS)40889942760320
  • d) Model Numbers DYNJ54153B
  • UDI/DI (EA)10889942714421
  • UDI/DI (CS)40889942714422
  • e) Model Numbers DYNJ54265A
  • UDI/DI (EA)10195327152338
  • UDI/DI (CS)40195327152339
  • f) Model Numbers DYNJ54750G
  • UDI/DI (EA)10195327021351
  • UDI/DI (CS)40195327021352
  • g) Model Numbers DYNJ54803C
  • UDI/DI (EA)10193489202618

Distribution

Distributed nationwide across the United States.

Related recalls

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