Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 575

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.

Part of a larger recall action

This product is one of 52 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 52 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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