Reported Mar 26, 2025 · Ongoing

Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS;…

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

16 of 16 products

Products covered by this recall
#	Product as published
1	Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW
2	SHEET, DRAPE, SPLIT, ST,10/CS
3	DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS
4	DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS
5	DRAPE,ABDOMINAL,MAJOR,ST,8/CS
6	DRAPE,ABDOMINAL,MAJOR,ST,8/CS
7	DRAPE,SPLIT,CVMAX,6/CS
8	DRAPE,ORTHOMAX ,BAR,6/CS
9	DRAPE,FEMORAL,RADIAL,5/CS
10	DRAPE,C-SECTION,FEN,CLR SCREEN,WIRE,7/CS
11	DRAPE,HAND,ULTRAGARD,18/CS
12	DRAPE,HAND,ULTRAGARD,18/CS
13	DRAPE,U,ORTHOMAX,6/CS
14	DRAPE,SPLIT,77X120",10/CS
15	DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS
16	DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS. Sterile surgical drape.

Lot codes and dates: 4 of 4 products
Products covered by this recall
Model / number Barcodes Product as published
DYNJCDCSEC01 DYNJP2498, DYNJP3102A, DYNJP3103, DYNJP4014, DYNJP4015, DYNJP4124, DYNJP6108, DYNJP8005UG, DYNJP8303, DYNJP8304A, DYNJP9108
— 408882773676794008019673949440080196778363400801967442214008019628730840080196770039400801961649442088827766884040080196574125400801967711114008019629243240080196152576 UDI (case): 40888277367679, 40080196739494, 40080196778363, 40080196744221, 40080196287308, 40080196770039, 40080196164944, 20888277668840, 40080196574125, 40080196771111, 40080196292432, 40080196152576
— 108882773676781008019673949310080196778362100801967442201008019628730710080196770038100801961649431088827766884310080196574124100801967711101008019629243110080196152575 UDI (each): 10888277367678, 10080196739493, 10080196778362, 10080196744220, 10080196287307, 10080196770038, 10080196164943, 10888277668843, 10080196574124, 10080196771110, 10080196292431, 10080196152575
— Lot No. 45024100168, 31124100039F, 31124090065F, 31124090066F, 31124090067F, 31124090068F, 45024090164, 31124090085F, 31124100084F, 45024100180, 72524050027, 72524060073, 31124090004H, 31124090045F, 45024100184, 45024100185.
Amount recalled: 1,482 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
`DYNJCDCSEC01`		DYNJP2498, DYNJP3102A, DYNJP3103, DYNJP4014, DYNJP4015, DYNJP4124, DYNJP6108, DYNJP8005UG, DYNJP8303, DYNJP8304A, DYNJP9108
—	`408882773676794008019673949440080196778363400801967442214008019628730840080196770039400801961649442088827766884040080196574125400801967711114008019629243240080196152576`	UDI (case): 40888277367679, 40080196739494, 40080196778363, 40080196744221, 40080196287308, 40080196770039, 40080196164944, 20888277668840, 40080196574125, 40080196771111, 40080196292432, 40080196152576
—	`108882773676781008019673949310080196778362100801967442201008019628730710080196770038100801961649431088827766884310080196574124100801967711101008019629243110080196152575`	UDI (each): 10888277367678, 10080196739493, 10080196778362, 10080196744220, 10080196287307, 10080196770038, 10080196164943, 10888277668843, 10080196574124, 10080196771110, 10080196292431, 10080196152575
—		Lot No. 45024100168, 31124100039F, 31124090065F, 31124090066F, 31124090067F, 31124090068F, 45024090164, 31124090085F, 31124100084F, 45024100180, 72524050027, 72524060073, 31124090004H, 31124090045F, 45024100184, 45024100185.