Reported Jul 26, 2023 · Ongoing

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following

26 of 26 products

Products covered by this recall
Model / numberProduct as published
DYNDA1224BBREAST BIOPSY KIT
DYNDH1121CU/S CORE BIOPSY KIT
DYNDH1124BIOPSY PACK
DYNDH1147AREVAMP BIOPSY TRAY
DYNDH1266BREAST BIOPSY TRAY
DYNDH1345ABREAST BIOPSY TRAY
DYNDH1496AULTRASOUND BREAST BIOPSY
DYNDH1534BASIC BIOPSY TRAY
DYNDH1542BULTRASOUND BIOPSY
DYNDH1670CABARRUS BIOPSY TRAY
DYNDH1677BREAST BIOPSY TRAY
DYNDH1748NORTH PARK BIOPSY TRAY
DYNDH1750SOFT TISSUE BIOPSY
DYNDH1750ASOFT TISSUE BIOPSY
DYNDH1778UL BIOPSY TRAY
DYNDH1822BREAST BIOPSY KIT
DYNDH1828ULTRASOUND BIOPSY
DYNJ0747885GBIOPSY PACK-LF
DYNJ34637GBIOPSY TRAY
DYNJ38616AIGT BIOPSY PACK-LF
Amount recalled
47185 units

This recall covers 53 products

The agency filed one notice per product. You are reading one of them; the other 52 are below.

40 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.