The Recall Desk
HighFDA (Devices)·Z-2165-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seams

Medline Industries is recalling probe cover kits used in diagnostic ultrasound procedures due to inadequate barrier protection at the seams. Over 3.7 million units distributed worldwide from December 2017 through 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 recall of sterile medical device with design defect (inadequate seam barrier) that poses risk of pathogen contamination during invasive diagnostic procedures. No illnesses or injuries have been reported, limiting severity to 3 per rubric criterion 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medline Industries, LP (Northfield) is recalling multiple models of probe cover kits containing sterile ultrasound gel. The kits are used in diagnostic and interventional ultrasound procedures for vascular, cardiac, and stroke applications. The recalled products include more than 80 model variants sold under different branded pack names.

The probe covers may have an inadequate barrier at the seams. This design defect could compromise the sterile integrity of the kit and potentially allow pathogen contamination during diagnostic ultrasound procedures.

Approximately 3.74 million units have been distributed worldwide, including throughout the United States and to international locations including Canada, India, China, Saudi Arabia, Qatar, United Arab Emirates, Singapore, Lebanon, Costa Rica, and Panama. All units with expiration dates still valid were distributed by Medline between December 2017 and May 2023.

Patients and healthcare providers with affected kits should discontinue use. Healthcare facilities should contact Medline Industries for instructions on product returns or replacements. Consult your facility's compliance officer or infection prevention team if there are concerns about exposure during past procedures.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PACK, Model Number DYNJ67771; c) EP PACK, Model Number DYNJ68019; d) GWINNETT ENDOVASCULAR WSTE MGT, Model Number DYNJ68198; e) TA
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound / Probe Covers
Hazard
  • inadequate-barrier
  • 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)10195327290979
  • UDI/DI (CS)40195327290970
  • b) Model Numbers DYNJ67771
  • UDI/DI (EA)10193489430721
  • UDI/DI (CS)40193489430722
  • c) Model Numbers DYNJ68019
  • UDI/DI (EA)10193489467840
  • UDI/DI (CS)40193489467841
  • d) Model Numbers DYNJ68198
  • UDI/DI (EA)10193489499179
  • UDI/DI (CS)40193489499170
  • e) Model Numbers DYNJ68499B
  • UDI/DI (EA)10195327034054
  • UDI/DI (CS)40195327034055
  • f) Model Numbers DYNJ68667
  • UDI/DI (EA)10193489837315
  • UDI/DI (CS)40193489837316
  • g) Model Numbers DYNJ68863
  • UDI/DI (EA)10193489845402

Distribution

Distributed nationwide across the United States.

Related recalls

Same category