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
| Model / number | Product as published |
|---|---|
DYNJ53433K | MHC VASCULAR HYBRID PK-LF |
DYNJ53616A | VEIN SPECIALISTS PACK |
DYNJ54014B | SUMMIT SKIN AND VEIN PACK |
DYNJ54153B | VEIN PACK |
DYNJ54265A | RFD-ENDOVASCULAR OR PACK |
DYNJ54750G | PEDI EP PACK |
DYNJ54803C | EL PASO VERICOSE VEIN PACK |
DYNJ54906B | LEE VEIN PACK |
DYNJ55528A | HEART FAILURE PK |
DYNJ55528B | HEART FAILURE PK |
DYNJ55528C | HEART FAILURE PK |
DYNJ55757C | ROCKWAY VASCULAR PACK-LF |
DYNJ55836B | OPEN HEART ANGIO PACK |
DYNJ56235 | DR NACKMAN VEIN PACK |
DYNJ56283D | KT TAVR PACK |
DYNJ56283F | KT TAVR PACK |
DYNJ56724B | VEIN PACK |
DYNJ56791A | VASCULAR PACK |
DYNJ56791B | VASCULAR PACK |
DYNJ56904 | ECMO PACK |
- Lot codes and dates
26 of 26 products
Products covered by this recall # Barcodes Product as published 1 1019532733948740195327339488Model Numbers DYNJ53433K, UDI/DI (EA)10195327339487, UDI/DI (CS)40195327339488 2 1088994268856240889942688563Model Numbers DYNJ53616A, UDI/DI (EA)10889942688562, UDI/DI (CS)40889942688563 3 1088994276032940889942760320Model Numbers DYNJ54014B, UDI/DI (EA)10889942760329, UDI/DI (CS)40889942760320 4 1088994271442140889942714422Model Numbers DYNJ54153B, UDI/DI (EA)10889942714421, UDI/DI (CS)40889942714422 5 1019532715233840195327152339Model Numbers DYNJ54265A, UDI/DI (EA)10195327152338, UDI/DI (CS)40195327152339 6 1019532702135140195327021352Model Numbers DYNJ54750G, UDI/DI (EA)10195327021351, UDI/DI (CS)40195327021352 7 1019348920261840193489202619Model Numbers DYNJ54803C, UDI/DI (EA)10193489202618, UDI/DI (CS)40193489202619 8 1019348928963340193489289634Model Numbers DYNJ54906B, UDI/DI (EA)10193489289633, UDI/DI (CS)40193489289634 9 1088994297663840889942976639Model Numbers DYNJ55528A, UDI/DI (EA)10889942976638, UDI/DI (CS)40889942976639 10 1019532704649140195327046492Model Numbers DYNJ55528B, UDI/DI (EA)10195327046491, UDI/DI (CS)40195327046492 11 1019532724820840195327248209Model Numbers DYNJ55528C, UDI/DI (EA)10195327248208, UDI/DI (CS)40195327248209 12 1019532711653840195327116539Model Numbers DYNJ55757C, UDI/DI (EA)10195327116538, UDI/DI (CS)40195327116539 13 1019348995117240193489951173Model Numbers DYNJ55836B, UDI/DI (EA)10193489951172, UDI/DI (CS)40193489951173 14 1088994262155240889942621553Model Numbers DYNJ56235, UDI/DI (EA)10889942621552, UDI/DI (CS)40889942621553 15 1019532709387740195327093878Model Numbers DYNJ56283D, UDI/DI (EA)10195327093877, UDI/DI (CS)40195327093878 16 1019532721185140195327211852Model Numbers DYNJ56283F, UDI/DI (EA)10195327211851, UDI/DI (CS)40195327211852 17 1019348946631740193489466318Model Numbers DYNJ56724B, UDI/DI (EA)10193489466317, UDI/DI (CS)40193489466318 18 1019348959411940193489594110Model Numbers DYNJ56791A, UDI/DI (EA)10193489594119, UDI/DI (CS)40193489594110 19 1019532704567840195327045679Model Numbers DYNJ56791B, UDI/DI (EA)10195327045678, UDI/DI (CS)40195327045679 20 1088994269345040889942693451Model Numbers DYNJ56904, UDI/DI (EA)10889942693450, UDI/DI (CS)40889942693451 - 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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