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
00-401185QNORTON CHILDRENS CATH LAB-LF
CDS840487IPERCUTANEOUS VASCULAR CDS
CDS983147IBAPTIST SOUTH OPEN HEART CV PK
CDS983394IENDOVASCULAR CDS
CDS983394JENDOVASCULAR CDS
CDS983394KENDOVASCULAR CDS
CDS983513FOPEN HEART CDS
CDS983849DOPEN HEART ANESTHESIA PACK
CDS983849FOPEN HEART ANESTHESIA PACK
CDS984292IVNUS
CDS984355GOPEN HEART CDS
CDS984642BEDSIDE PICC CDS
CDS984764GVASCULAR
CDS985105OOPEN HEART A
CDS985355DVASCULAR
CDS985355FVASCULAR
CVI4955ECMO KIT
DYKMBNDL21KIT CARDIAC CSICU ADULT ECMO
DYNDA2526VASCULAR ACCESS PROCEDURE KIT
DYNDC3038ARTERIAL/VENOUS ACCESS TRAY
Amount recalled
172722 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, 6:19 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.