The Recall Desk
HighFDA (Devices)·Z-2186-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barrier

Medline is recalling 14,848 ultrasound probe cover kits due to potentially inadequate barriers at the seams. The kits were distributed worldwide between December 2017 and May 2023 for use in 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 probe covers used in invasive diagnostic procedures where an inadequate seam barrier could allow contamination. No illnesses or injuries have been reported; the hazard is theoretical, consistent with a High severity classification for risk-of-harm products without reported harm.

Plain-English summary

Medline Industries, LP is recalling 14,848 ultrasound probe cover kits containing sterile gel due to potentially inadequate barriers at the seams. These kits were distributed worldwide between December 2017 and May 2023 for use in diagnostic ultrasound procedures, including angiography and neurology applications.

The affected products include multiple model numbers such as DBS Packs, Neuro Arteriogram Packs, Angiographic Packs, and others. Distribution included the United States and international locations including United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

Users of these products should verify their products against the model numbers and UDI codes provided on the FDA website, and discontinue use of any affected units. Contact Medline Industries or your healthcare provider for guidance on replacement or disposal.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G; b) DBS PACK-LF, Model Number DYNJ0878178J; c) DBS PACK-LF, Model Number DYNJ0878178K; d) NEURO ARTERIOGRAM PACK-LF, Model Numbe
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound / Diagnostic
Hazard
  • inadequate-barrier
  • 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) 10193489711554
  • UDI/DI (CS) 40193489711555
  • b) Model Number DYNJ0878178J
  • UDI/DI (EA) 10193489914368
  • UDI/DI (CS) 40193489914369
  • c) Model Number DYNJ0878178K
  • UDI/DI (EA) 10195327328788
  • UDI/DI (CS) 40195327328789
  • d) Model Number DYNJ0948060F
  • UDI/DI (EA) 10889942825103
  • UDI/DI (CS) 40889942825104
  • e) Model Number DYNJ35066I
  • UDI/DI (EA) 10193489262292
  • UDI/DI (CS) 40193489262293
  • f) Model Number DYNJ35066J
  • UDI/DI (EA) 10195327091071
  • UDI/DI (CS) 40195327091072
  • g) Model Number DYNJ39198L
  • UDI/DI (EA) 10193489262919

Distribution

Distributed nationwide across the United States.

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