The Recall Desk
HighFDA (Devices)·Z-2161-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Defective Seam Barriers

Medline Industries recalls probe cover kits used in diagnostic ultrasound procedures because the covers may have inadequate barriers at the seams. Approximately 3.7 million units 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 recall with no reported illnesses or injuries. The hazard—inadequate barriers at seams—is a structural defect affecting the protective function of the covers. This represents a risk-of-harm product where injury has not yet been reported, placing it in the High severity category.

Plain-English summary

Medline Industries, LP is recalling multiple models of probe cover kits containing sterile ultrasound gel used during diagnostic ultrasound procedures. The covers may have inadequate barriers at the seams.

Approximately 3,740,814 units are affected by this recall. The kits were distributed worldwide between December 2017 and May 2023. Distribution included the United States and international locations including United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

The recall affects 89 different model numbers of Medline probe cover kits, each with specific UDI identifiers. All affected lots within their expiration dates are included.

Healthcare facilities and medical professionals using these probe covers should discontinue use and verify their inventory against the affected model numbers and UDI identifiers provided. Contact Medline Industries, LP for information about replacement or return of affected products.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c) CATH LAB 2, Model Number DYNJ55680A; d) IR ANGIO TRAY, Model Number DYNJ56038A; e) CATH PACK, Mod
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound Probe Covers
Hazard
  • seam-defect
  • barrier-defect

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)10195327267919
  • UDI/DI (CS)40195327267910
  • b) Model Number DYNJ55455A
  • UDI/DI (EA)10193489386233
  • UDI/DI (CS)40193489386234
  • c) Model Number DYNJ55680A
  • UDI/DI (EA)10889942639786
  • UDI/DI (CS)40889942639787
  • d) Model Number DYNJ56038A
  • UDI/DI (EA)10195327347840
  • UDI/DI (CS)40195327347841
  • e) Model Number DYNJ56547C
  • UDI/DI (EA)10193489879834
  • UDI/DI (CS)40193489879835
  • f) Model Number DYNJ57049G
  • UDI/DI (EA)10195327110390
  • UDI/DI (CS)40195327110391
  • g) Model Number DYNJ57049I
  • UDI/DI (EA)10195327207731

Distribution

Distributed nationwide across the United States.

Related recalls

Same category