Reported Aug 9, 2023 · Ongoing

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz 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?

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following

26 of 26 products

Products covered by this recall
Model / number	Product as published
`DYNJ0842825D`	ELECTROPHYSIOLOGY PACK-LF
`DYNJ49933I`	EMANUEL EP TRAY, , DYNJ49933J
`DYNJ44808G`	ENDO LASER ABLATION PK-LF
`DYNJ51304B`	ENDO VASCULAR, , DYNJ51304C
—	ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567
`DYNJ0676055N`	ENDO VASCULAR PACK-LF
—	ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880
`CDS983394I`	ENDOVASCULAR CDS, , CDS983394J, CDS983394K
`DYNJVB91067`	ENDOVASCULAR IMF 88370-LF
`DYNJ906354D`	ENDOVASCULAR KIT, , DYNJ906354F
`DYNJ0678934I`	ENDOVASCULAR PACK, , DYNJ44934F, DYNJ905726C, DYNJ905726D
`DYNJ42831F`	ENDOVASCULAR PACK-LF
`DYNJ67750`	ENDOVASCULAR -TEMPLE, , DYNJ67750A, DYNJ67750B, DYNJ67750C
`DYNJ80489`	ENDOVENOUS ABLATION PACK
`DYNJ48456C`	ENDOVENOUS BASIC PACK, , DYNJ69108A
`DYNJ83606`	ENDOVENOUS PACK
`SYNJ910018B`	ENT FREE FLAP
`DYNJ25749S`	EP ANGIO PACK
`DYNJ47645C`	EP DRAPE PACK-LF
`DYNJ59392D`	EP LAB, , DYNJ59392F

Lot codes and dates: 26 of 26 products
Products covered by this recall
Model / number Barcodes Product as published
DYNJ0842825D 019532728861 UPC Number: 019532728861.
DYNJ49933J 019348947168019532706561 Model Number: DYNJ49933I, UPC Number: 019348947168; , UPC Number: 019532706561.
DYNJ44808G 019348987585 UPC Number: 019348987585.
DYNJ51304C 088994236595019348946098 Model Number: DYNJ51304B, UPC Number: 088994236595; , UPC Number: 019348946098.
DYNJ82567 019348956435019348956435019532719803 Model Number: DYNJ0678934D, UPC Number: 019348956435; Model Number: DYNJ0678934F, UPC Number: 019348956435; , UPC Number: 019532719803.
DYNJ0676055N 019348956435 UPC Number: 019348956435.
DYNJ908880 019348929199019348947045019348996760019532708613019532720343 Model Number: DYNJ63343A, UPC Number: 019348929199; Model Number: DYNJ63343B, UPC Number: 019348947045; Model Number: DYNJ63343D, UPC Number: 019348996760; Model Number: DYNJ63343F, UPC Number: 019532708613; , UPC Number: 019532720343.
CDS983394K 019348981995019532706987019532729258 Model Number: CDS983394I, UPC Number: 019348981995; Model Number: CDS983394J, UPC Number: 019532706987; , UPC Number: 019532729258.
DYNJVB91067 019348980153 UPC Number: 019348980153.
DYNJ906354F 019348998657019532702150 Model Number: DYNJ906354D, UPC Number: 019348998657; , UPC Number: 019532702150.
DYNJ905726D 019348999786019348944613019348994337019532716151 Model Number: DYNJ0678934I, UPC Number: 019348999786; Model Number: DYNJ44934F, UPC Number: 019348944613; Model Number: DYNJ905726C, UPC Number: 019348994337; , UPC Number: 019532716151.
DYNJ42831F 019348988032 UPC Number: 019348988032.
DYNJ67750C 019348942917019348983224019348991204019532734136 Model Number: DYNJ67750, UPC Number: 019348942917, Model Number: DYNJ67750A, UPC Number: 019348983224, Model Number: DYNJ67750B, UPC Number: 019348991204, , UPC Number: 019532734136.
DYNJ80489 019532704584 UPC Number: 019532704584.
DYNJ69108A 019532701586019532702571 Model Number: DYNJ48456C, UPC Number: 019532701586; , UPC Number: 019532702571.
DYNJ83606 019532728485 UPC Number: 019532728485.
SYNJ910018B 019532700730 UPC Number: 019532700730.
DYNJ25749S 019532705970 UPC Number: 019532705970.
DYNJ47645C 019532735517 UPC Number: 019532735517.
DYNJ59392F 019532705357019532713598 Model Number: DYNJ59392D, UPC Number: 019532705357; , UPC Number: 019532713598.
Page 1 of 2
Amount recalled: 41,123 kits

This recall covers 50 products

The agency filed one notice per product. You are reading one of them; the other 49 are below.

37 more are in the archive.

Where it was sold

Nationwide

Why it was recalled

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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

Model / number	Barcodes	Product as published
`DYNJ0842825D`	`019532728861`	UPC Number: 019532728861.
`DYNJ49933J`	`019348947168019532706561`	Model Number: DYNJ49933I, UPC Number: 019348947168; , UPC Number: 019532706561.
`DYNJ44808G`	`019348987585`	UPC Number: 019348987585.
`DYNJ51304C`	`088994236595019348946098`	Model Number: DYNJ51304B, UPC Number: 088994236595; , UPC Number: 019348946098.
`DYNJ82567`	`019348956435019348956435019532719803`	Model Number: DYNJ0678934D, UPC Number: 019348956435; Model Number: DYNJ0678934F, UPC Number: 019348956435; , UPC Number: 019532719803.
`DYNJ0676055N`	`019348956435`	UPC Number: 019348956435.
`DYNJ908880`	`019348929199019348947045019348996760019532708613019532720343`	Model Number: DYNJ63343A, UPC Number: 019348929199; Model Number: DYNJ63343B, UPC Number: 019348947045; Model Number: DYNJ63343D, UPC Number: 019348996760; Model Number: DYNJ63343F, UPC Number: 019532708613; , UPC Number: 019532720343.
`CDS983394K`	`019348981995019532706987019532729258`	Model Number: CDS983394I, UPC Number: 019348981995; Model Number: CDS983394J, UPC Number: 019532706987; , UPC Number: 019532729258.
`DYNJVB91067`	`019348980153`	UPC Number: 019348980153.
`DYNJ906354F`	`019348998657019532702150`	Model Number: DYNJ906354D, UPC Number: 019348998657; , UPC Number: 019532702150.
`DYNJ905726D`	`019348999786019348944613019348994337019532716151`	Model Number: DYNJ0678934I, UPC Number: 019348999786; Model Number: DYNJ44934F, UPC Number: 019348944613; Model Number: DYNJ905726C, UPC Number: 019348994337; , UPC Number: 019532716151.
`DYNJ42831F`	`019348988032`	UPC Number: 019348988032.
`DYNJ67750C`	`019348942917019348983224019348991204019532734136`	Model Number: DYNJ67750, UPC Number: 019348942917, Model Number: DYNJ67750A, UPC Number: 019348983224, Model Number: DYNJ67750B, UPC Number: 019348991204, , UPC Number: 019532734136.
`DYNJ80489`	`019532704584`	UPC Number: 019532704584.
`DYNJ69108A`	`019532701586019532702571`	Model Number: DYNJ48456C, UPC Number: 019532701586; , UPC Number: 019532702571.
`DYNJ83606`	`019532728485`	UPC Number: 019532728485.
`SYNJ910018B`	`019532700730`	UPC Number: 019532700730.
`DYNJ25749S`	`019532705970`	UPC Number: 019532705970.
`DYNJ47645C`	`019532735517`	UPC Number: 019532735517.
`DYNJ59392F`	`019532705357019532713598`	Model Number: DYNJ59392D, UPC Number: 019532705357; , UPC Number: 019532713598.