The Recall Desk
HighFDA (Devices)·Z-2180-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers

Medline Industries is recalling ultrasound probe cover kits with inadequate barriers at the seams that could allow contamination during procedures. Approximately 3.7 million units distributed worldwide between December 2017 and May 2023 are affected.

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: FDA Class II medical device with a critical sterile barrier defect affecting approximately 3.7 million units globally. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, per High severity criteria.

Plain-English summary

Medline Industries, LP is recalling multiple models of ultrasound probe cover kits containing sterile ultrasound gel. The recalled products include numerous kit variants such as Vein Kits, Facelift Packs, Clot Retrieval Packs, Venous Packs, and specialized procedure packs for various medical procedures. Approximately 3.7 million units were distributed worldwide, including to the United States and to countries including the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. Products were distributed between December 2017 and May 2023.

The probe covers may have inadequate barriers at the seams, which could allow contamination during diagnostic ultrasound procedures.

Healthcare facilities that have received these probe cover kits should consult the FDA recall notice for the specific model numbers and UDI codes to identify affected products. Patients who have undergone ultrasound procedures using these probe covers should contact their healthcare provider with any concerns.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC ULTRASOUND
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device
Hazard
  • barrier-defect
  • contamination

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) 10888277757684
  • UDI/DI (CS) 40888277757685
  • b) Model Number DYNJ55954B
  • UDI/DI (EA) 10193489214239
  • UDI/DI (CS) 40193489214230
  • c) Model Number DYNJ56140B
  • UDI/DI (EA) 10193489547672
  • UDI/DI (CS) 40193489547673
  • d) Model Number DYNJ56260B
  • UDI/DI (EA) 10193489569827
  • UDI/DI (CS) 40193489569828
  • e) Model Number DYNJ56392
  • UDI/DI (EA) 10889942640676
  • UDI/DI (CS) 40889942640677
  • f) Model Number DYNJ56392A
  • UDI/DI (EA) 10195327261405
  • UDI/DI (CS) 40195327261406
  • g) Model Number DYNJ56392B
  • UDI/DI (EA) 10195327323677

Distribution

Distributed nationwide across the United States.

Related recalls

Same category