Reported Mar 26, 2025 · Ongoing

Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO…

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

13 of 13 products

Products covered by this recall
#	Product as published
1	Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS
2	PACK,BASIC IV,SIRUS,5/CS
3	PACK,SET UP,NO DRAPE,12/CS
4	PACK,SET UP,NO DRAPE,12/CS
5	PACK,SET UP,NO DRAPE,12/CS
6	PACK,SET UP,NO DRAPE,12/CS
7	PACK,SET UP,NO DRAPE,12/CS
8	PACK,UNIVERSAL II,SIRUS,7/CS
9	PACK,LAPAROTOMY,NO GOWN,10/CS
10	PACK,CYSTOSCOPY,PK VI,14/CS
11	PACK,CYSTOSCOPY,PK VI,14/CS
12	PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS
13	PACK,LAVH,AURORA,4/CS. Sterile surgical drape.

Lot codes and dates: 4 of 4 products
Products covered by this recall
Model / number Barcodes Product as published
DYNJP1020S DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, DYNJP9120A
— 4008019630812640080196308133400801967228924008019630819540080196722946400801967533914088438911029540080196915416 UDI (case): 40080196308126, 40080196308133, 40080196722892, 40080196308195, 40080196722946, 40080196753391, 40884389110295, 40080196915416
— 1008019630812510080196308132100801967228911008019630819410080196722945100801967533901088438911029410080196915415 UDI (each): 10080196308125, 10080196308132, 10080196722891, 10080196308194, 10080196722945, 10080196753390, 10884389110294, 10080196915415
— Lot No. 31124090044H, 31124090028F, 31124080024F, 31124080061F, 31124090029F, 31124090089F, 31124100077F, 31124090030H, 31124090054F, 31124070070F, 31124080063F, 45024090166, 31124100007F.
Amount recalled: 1,490 units

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Potential breach in pouch packaging which could lead to loss of sterility.

This product could cause temporary or reversible health problems — stop using it.

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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80 in total.

Model / number	Barcodes	Product as published
`DYNJP1020S`		DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, DYNJP9120A
—	`4008019630812640080196308133400801967228924008019630819540080196722946400801967533914088438911029540080196915416`	UDI (case): 40080196308126, 40080196308133, 40080196722892, 40080196308195, 40080196722946, 40080196753391, 40884389110295, 40080196915416
—	`1008019630812510080196308132100801967228911008019630819410080196722945100801967533901088438911029410080196915415`	UDI (each): 10080196308125, 10080196308132, 10080196722891, 10080196308194, 10080196722945, 10080196753390, 10884389110294, 10080196915415
—		Lot No. 31124090044H, 31124090028F, 31124080024F, 31124080061F, 31124090029F, 31124090089F, 31124100077F, 31124090030H, 31124090054F, 31124070070F, 31124080063F, 45024090166, 31124100007F.