Lower risk Medical device recall · FDA · Published February 13, 2025

Medline Proxima Drape: Risk of Sterility Loss in Packaging

Medline recalls Proxima Drape surgical drapes due to potential pouch packaging breach that could compromise sterility. Affected items include specific model numbers and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1364-2025Medical device Medline ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753

✎ GovInfoNow plain-language explainer

Medline is recalling certain Proxima Drape surgical drapes because the packaging might not stay sterile. This could lead to infections during surgery if the drapes are used without proper sterility. Read more at govinfonow.com/recall/52863-medline-proxima-drape-risk-of-sterility-loss-in-packaging.

Source Summary by GovInfoNow · govinfonow.com/recall/52863-medline-proxima-drape-risk-of-sterility-loss-in-packaging · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1364-2025

Cite this page

“Medline Proxima Drape: Risk of Sterility Loss in Packaging.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52863-medline-proxima-drape-risk-of-sterility-loss-in-packaging. Based on FDA recall #Z-1364-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1364-2025%22&limit=1).

The FDA announced on Feb. 13, 2025, that Medline Industries LP is recalling Proxima Drape products due to potential packaging breaches that could compromise sterility. The voluntary Class II recall affects 1,490 units distributed nationwide.

How to tell if you have it

Brand: Medline
Product: 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 DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS; PACK,LAVH,AURORA,4/CS
Item No.: DYNJP1020S, DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, DYNJP9120A
UDI (case): 40080196308126, 40080196308133, 40080196722892, 40080196308195, 40080196722946, 40080196753391, 40884389110295, 40080196915416
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
Distribution: US Nationwide

The hazard

The recall cites a potential breach in the pouch packaging which could lead to loss of sterility for these sterile surgical drapes.

Context

GovInfoNow's records show Medline Industries LP has issued 119 other recalls since Oct. 22, 2021. Recent brand recalls include medical kits with light failures on July 25, 2025, and Foley tray kits with incorrect labeling on July 23, 2025. Other recent recalls of similar products include Medline Surgical Drapes Recall regarding sterility risk from calibration issues (Jan. 7, 2026) and Medline Quick-Strip Bandages Recall for open packaging compromising sterility (Oct. 27, 2025).

How to tell if you have this one

Check for model numbers DYNJP1020S, DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, DYNJP9120A or lot numbers like 31124090044H. These drapes were sold with specific packaging labels.

Brand
Medline
Category
Medical device

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-1363-2025	Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRAPE,FEMORAL,RADIAL,5/CS; DRAPE,C-SECTION,FEN,CLR SCREEN,WIRE,7/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,U,ORTHOMAX,6/CS; DRAPE,SPLIT,77X120",10/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS. Sterile surgical drape.; Item No. DYNJCDCSEC01, DYNJP2498, DYNJP3102A, DYNJP3103, DYNJP4014, DYNJP4015, DYNJP4124, DYNJP6108, DYNJP8005UG, DYNJP8303, DYNJP8304A, DYNJP9108; UDI (case): 40888277367679, 40080196739494, 40080196778363, 40080196744221, 40080196287308, 40080196770039, 40080196164944, 20888277668840, 40080196574125, 40080196771111, 40080196292432, 40080196152576; 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.	1,482 units
Z-1364-2025	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 DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,CYSTOSCOPY,PK VI,14/CS; PACK,OB III,GRADUATED UNDERBUTTOCK,6/CS; PACK,LAVH,AURORA,4/CS. Sterile surgical drape.; Item No. DYNJP1020S, DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, DYNJP9120A; UDI (case): 40080196308126, 40080196308133, 40080196722892, 40080196308195, 40080196722946, 40080196753391, 40884389110295, 40080196915416; 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.	1,490 units
Z-1365-2025	Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.; Item No. DYNJ84258A & DYNJ84258B; UDI (case): 40195327650743 & 40198459117986; UDI (each): 10195327650742 & 10198459117985; Lot No. (Shelf Life) 24HBK264 (12/31/26) & 24IBD271 (7/31/26). .	114 units
Z-1366-2025	Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.; Item No. DYNJ34603F & DYNJ903916I; UDI (case): 40198459143596 & 40195327580118; UDI (each): 10198459143595 & 10195327580117; Lot No. (Shelf Life) 25AMD464(11/30/2029), 24JMC011(04/30/2029), 25ABA362(09/30/2025), 24KBT718(02/28/2026), 24JBE997(09/30/2025), 24IBM203(02/28/2026).	506 units
Z-1367-2025	Proxima Drape labeled as FACE LIFT. Sterile surgical drape.; Item No.DYNJ910462; UDI (case): 40195327695638; UDI (each): 10195327695637; Lot No. (Shelf Life) 24JMD608 (06/30/2026).	16 units
Z-1368-2025	Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.; Item No. DYNJ35520B, DYNJ38529F, DYNJ43406F, DYNJ43421D, DYNJ69185A, DYNJ69340B, DYNJ88923; UDI (case): 40198459106904, 40195327693870, 40198459074005, 40198459074784, 40195327582839, 40198459026127, 40198459216856; UDI (each): 10198459106903, 10195327693879, 10198459074004, 10198459074783, 10195327582838, 10198459026126, 10198459216855; Lot No. (Shelf Life) 24KMB843(05/31/2027), 24IMD400(01/31/2027), 24IMB784(01/31/2027), 24LBK460(02/28/2027), 24JBY288(12/31/2026), 24LBJ155(01/31/2027), 24JBU154(12/31/2026), 24HBP361(11/30/2026), 24HBA919(10/31/2026), 24JBX700(06/30/2026), 24JBC370(04/30/2026), 24IBI711(04/30/2026), 24HBO453(04/30/2026), 24HBA954(01/31/2026), 24JBK365(04/30/2026), 24HBR810(04/30/2026), 24GBX503(03/31/2026), 24LBO297(06/30/2026), 24JBV432(06/30/2026), 24IBU974(05/31/2026), 24HBR072(04/30/2026), 25ABB569(02/10/2026).	2,422 units
Z-1369-2025	Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.; Item No. DYNJ53968P; UDI (case): 40195327532759; UDI (each): 10195327532758; Lot No. (Shelf Life) 24KMC372 (3/31/2026), 24IMJ082 (4/30/2026), 24HMK377 (4/30/2026). .	220 units
Z-1370-2025	Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.; Item No. CDS985210G, CDS985210G, CDS985210G, DYNJ65826A, DYNJ65826A, DYNJ65826A, DYNJ65826A, DYNJ87398, DYNJ87398, DYNJ908743C, DYNJ908743C, DYNJ908743C, DYNJ908743C, DYNJ908744C, DYNJ908744C, DYNJ908744C, DYNJ910326B; UDI (case): 40195327553310, 40195327516193, 40198459034405, 40195327636297, 40195327636280, 40198459075002; UDI (each): 10195327553319, 10195327516192, 10198459034404, 10195327636296, 10195327636289, 10198459075001; Lot No. (Shelf Life) 24LBK011(04/30/2026), 24JBR548(02/28/2026), 24IBN166(02/28/2026), 24KMF425(06/30/2026), 24JMI243(06/30/2026), 24IMI316(05/31/2026), 24HMH127(04/30/2026), 24JBW476(02/28/2026), 24HBK163(02/28/2026), 24KBA490(02/28/2026), 24JBM980(02/28/2026), 24JBB973(02/28/2026), 24IBQ750(03/31/2026), 24JBM981(02/28/2026), 24JBH713(02/28/2026), 24HBJ792(02/28/2026), 24KBQ357(12/31/2025).	1,118 units

Based on the official FDA remedy

What to do — step by step

Check Product Labels
Look for model numbers DYNJP1020S, DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, DYNJP9120A or lot numbers listed in the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 41 days after the firm started it.

Feb 13, 2025Firm started the recall
Mar 14, 2025FDA classified it Class II
Mar 26, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/52863-medline-proxima-drape-risk-of-sterility-loss-in-packaging">Medline Proxima Drape: Risk of Sterility Loss in Packaging (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1364-2025 (February 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1364-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.