The Recall Desk
HighFDA (Devices)·Z-2198-2023·Announced 2023-07-26

Medline Probe Cover Kits recalled due to inadequate seam barriers

Medline Probe Cover Kits may have inadequate seam barriers that could allow contamination during diagnostic ultrasound procedures. Approximately 575 units have been distributed worldwide since December 2017.

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 a medical device with a potential contamination risk due to inadequate seam barriers on sterile probe covers. No illnesses or injuries are documented in the recall notice, placing this at the High severity level per the rubric criteria for risk-of-harm products where injury has not been reported.

Plain-English summary

Medline Industries, LP is recalling Probe Cover Kits containing sterile Ultrasound Gel. The recall includes three models: ULTRASOUND PACK (Model DYNDH1112), PARA THORACENTESIS TRAY (Model DYNDH1165A), and ULTRASOUND TRAY (Model DYNDH1204). A total of 575 units have been distributed worldwide, with distribution dates ranging from December 2017 through May 2023.

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

The affected kits were distributed throughout the United States and internationally to United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Diagnostic Ultrasound / Sterile Kits
Hazard
  • contamination
  • infection

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 (9)

  • All lots within expiry
  • UDI/DI (EA) 10889942277360
  • UDI/DI (CS) 40889942277361
  • b) Model Number DYNDH1165A
  • UDI/DI (EA) 10889942611508
  • UDI/DI (CS) 40889942611509
  • c) Model Number DYNDH1204
  • UDI/DI (EA) 10889942519835
  • UDI/DI (CS) 40889942519836

Distribution

Distributed nationwide across the United States.

Related recalls

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