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

16 of 16 products

Products covered by this recall
Model / numberProduct as published
DYNJRA1755BLOCK SUPPLIES NDL CNTR
DYNJTESTCFP4VNUS TEST KIT CFP-LF
IV8635DULTRASOUND PIV BUNDLE
IVS3300ULTRASOUND GUIDED PIV KIT
IVS3485AULTRASOUND GUIDED PIV INSERTIO
IVS3825EPIV PROCEDURE TRAY
IVS3840AULTRASOUND GUIDED PIV INSERTIO
MNS11625RADIOLOGY TRAY
MNS7695ABEDSIDE PROCEDURE PREP KIT
NG410ANGHS EVOR ANGIO PACK
PHS41739APICC INSERT KIT-LESS THAN 3 FR
PHS479840MRADIOLOGY SPECIALS PACK
SYNJ10303BHYBRID OR PACK
TVS4500ATVS4500 MULTI PURPOSE VEIN
TVS4500BTVS4500 MULTI PURPOSE VEIN
VC PROCEDURE KIT, Model Number VC-PK
Amount recalled
# included in 3,740,814 units total

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, 4:50 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.