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
DYNJ906102GSILVER CROSS OPEN HEART
DYNJ906102ISILVER CROSS OPEN HEART
DYNJ906108CCUSTOM CARDIAC CABG
DYNJ906440AVASCULAR STENT INOVA
DYNJ906878ACABG
DYNJ906882AVALVE
DYNJ906883AVASCULAR
DYNJ907552ADR WILLIAMS HEART
DYNJ907554CPUH PERCUTANEOUS ECMO
DYNJ907561ATAVR
DYNJ907561BTAVR
DYNJ907561CTAVR
DYNJ907607AOPEN HEART CDS
DYNJ907607BOPEN HEART CDS
DYNJ907607COPEN HEART CDS
DYNJ907858AOPEN VASCULAR UE
DYNJ907907PACEMAKER
DYNJ907914ADEBOER HEART
DYNJ907914BDEBOER HEART
DYNJ907914CDEBOER HEART
Lot codes and dates

26 of 26 products

Products covered by this recall
#BarcodesProduct as published
11019532729079540195327290796Model Numbers DYNJ906102G, UDI/DI (EA)10195327290795, UDI/DI (CS)40195327290796
21019532732334940195327323340Model Numbers DYNJ906102I, UDI/DI (EA)10195327323349, UDI/DI (CS)40195327323340
31019532711827340195327118274Model Numbers DYNJ906108C, UDI/DI (EA)10195327118273, UDI/DI (CS)40195327118274
41019348931287440193489312875Model Numbers DYNJ906440A, UDI/DI (EA)10193489312874, UDI/DI (CS)40193489312875
51019348939130540193489391306Model Numbers DYNJ906878A, UDI/DI (EA)10193489391305, UDI/DI (CS)40193489391306
61019348939123740193489391238Model Numbers DYNJ906882A, UDI/DI (EA)10193489391237, UDI/DI (CS)40193489391238
71019348939820540193489398206Model Numbers DYNJ906883A, UDI/DI (EA)10193489398205, UDI/DI (CS)40193489398206
81019532716605240195327166053Model Numbers DYNJ907552A, UDI/DI (EA)10195327166052, UDI/DI (CS)40195327166053
91019532718383740195327183838Model Numbers DYNJ907554C, UDI/DI (EA)10195327183837, UDI/DI (CS)40195327183838
101019532702884840195327028849Model Numbers DYNJ907561A, UDI/DI (EA)10195327028848, UDI/DI (CS)40195327028849
111019532729083240195327290833Model Numbers DYNJ907561B, UDI/DI (EA)10195327290832, UDI/DI (CS)40195327290833
121019532732327140195327323272Model Numbers DYNJ907561C, UDI/DI (EA)10195327323271, UDI/DI (CS)40195327323272
131019348987340540193489873406Model Numbers DYNJ907607A, UDI/DI (EA)10193489873405, UDI/DI (CS)40193489873406
141019532717419440195327174195Model Numbers DYNJ907607B, UDI/DI (EA)10195327174194, UDI/DI (CS)40195327174195
151019532733551940195327335510Model Numbers DYNJ907607C, UDI/DI (EA)10195327335519, UDI/DI (CS)40195327335510
161019532713135740195327131358Model Numbers DYNJ907858A, UDI/DI (EA)10195327131357, UDI/DI (CS)40195327131358
171019348993973640193489939737Model Numbers DYNJ907907, UDI/DI (EA)10193489939736, UDI/DI (CS)40193489939737
181019532714952940195327149520Model Numbers DYNJ907914A, UDI/DI (EA)10195327149529, UDI/DI (CS)40195327149520
191019532718060740195327180608Model Numbers DYNJ907914B, UDI/DI (EA)10195327180607, UDI/DI (CS)40195327180608
201019532732943340195327329434Model Numbers DYNJ907914C, UDI/DI (EA)10195327329433, UDI/DI (CS)40195327329434
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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Other recalls from MEDLINE INDUSTRIES, LP - Northfield

80 in total.

All recall categories · Browse the whole archive

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:38 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.