Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Proxima Sterile Surgical Drapes Recalled for Potential Sterility Loss

Agency Publication Date: March 14, 2025
Share:
Sign in to monitor this recall

Summary

Medline Industries, LP has recalled 7,368 Proxima Sterile Surgical Drapes and various surgical procedure packs due to a potential breach in the pouch packaging. This defect could cause the devices to lose their sterility, which is critical for preventing infections during surgery. The recall affects specialized drapes used in C-sections, laparoscopy, orthopedic surgeries, and robotic-assisted procedures. Healthcare facilities and surgical centers should stop using the affected products and contact Medline or their distributor for a return or replacement.

Risk

A breach in sterile packaging could allow bacteria or other contaminants to enter, increasing the risk of surgical site infections for patients. No incidents or injuries have been reported to date regarding this issue.

What You Should Do

  1. This recall involves several models of Proxima Sterile Surgical Drapes and procedure packs, including specialized drapes for C-sections, abdominal surgery, orthopedic procedures, and robotic surgery.
  2. Check the item number, lot number, and Unique Device Identifier (UDI) printed on the product label or packaging to determine if your surgical products are affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Medline Industries, LP or your authorized medical supply distributor to arrange for a return, replacement, or correction of the inventory.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) or visit the FDA medical device recall website for additional consumer safety information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Proxima Drape (C-Section, Laparoscopy, Abdominal, Ortho, and Hand variants)
Variants: C-SECTION W/ WINDOW, SHEET, DRAPE, SPLIT, ST, 10/CS, LAPAROSCOPY, CHOLE, W/TROUGH, ST, 8/CS, ABDOMINAL, MAJOR, ST, 8/CS, SPLIT, CVMAX, 6/CS, ORTHOMAX, BAR, 6/CS, FEMORAL, RADIAL, 5/CS, C-SECTION, FEN, CLR SCREEN, WIRE, 7/CS, HAND, ULTRAGARD, 18/CS, U, ORTHOMAX, 6/CS, SPLIT, 77X120", 10/CS, ROBOTIC, W/LEGGING, W/POUCH, 5/CS
Model / REF:
DYNJCDCSEC01
DYNJP2498
DYNJP3102A
DYNJP3103
DYNJP4014
DYNJP4015
DYNJP4124
DYNJP6108
DYNJP8005UG
DYNJP8303
DYNJP8304A
DYNJP9108
Lot Numbers:
45024100168
31124100039F
31124090065F
31124090066F
31124090067F
31124090068F
45024090164
31124090085F
31124100084F
45024100180
72524050027
72524060073
31124090004H
31124090045F
45024100184
45024100185
UDI:
40888277367679
40080196739494
40080196778363
40080196744221
40080196287308
40080196770039
40080196164944
20888277668840
40080196574125
40080196771111
40080196292432
40080196152576
10888277367678
10080196739493
10080196778362
10080196744220
10080196287307
10080196770038
10080196164943
10888277668843
10080196574124
10080196771110
10080196292431
10080196152575

Recall #: Z-1363-2025; Quantity: 1,482 units.

Product: Proxima Drape Packs (Sirus, Basic, Laparotomy, and Cystoscopy variants)
Variants: PACK, BASIC, SIRUS, V, PACK, BASIC IV, SIRUS, PACK, SET UP, NO DRAPE, PACK, UNIVERSAL II, SIRUS, PACK, LAPAROTOMY, NO GOWN, PACK, CYSTOSCOPY, PK VI, PACK, OB III, GRADUATED UNDERBUTTOCK, PACK, LAVH, AURORA
Model / REF:
DYNJP1020S
DYNJP1025S
DYNJP1040
DYNJP1055S
DYNJP3000
DYNJP5050
DYNJP6060S
DYNJP9120A
Lot Numbers:
31124090044H
31124090028F
31124080024F
31124080061F
31124090029F
31124090089F
31124100077F
31124090030H
31124090054F
31124070070F
31124080063F
45024090166
31124100007F
UDI:
40080196308126
40080196308133
40080196722892
40080196308195
40080196722946
40080196753391
40884389110295
40080196915416
10080196308125
10080196308132
10080196722891
10080196308194
10080196722945
10080196753390
10884389110294
10080196915415

Recall #: Z-1364-2025; Quantity: 1,490 units.

Product: Proxima Drape ENT-PLASTICS PACK
Model / REF:
DYNJ84258A
DYNJ84258B
Lot Numbers:
24HBK264 (Exp 12/31/26)
24IBD271 (Exp 7/31/26)
UDI:
40195327650743
40198459117986
10195327650742
10198459117985

Recall #: Z-1365-2025; Quantity: 114 units.

Product: Proxima Drape MINOR PACK and LAPAROSCOPY
Model / REF:
DYNJ34603F
DYNJ903916I
Lot Numbers:
25AMD464 (Exp 11/30/2029)
24JMC011 (Exp 04/30/2029)
25ABA362 (Exp 09/30/2025)
24KBT718 (Exp 02/28/2026)
24JBE997 (Exp 09/30/2025)
24IBM203 (Exp 02/28/2026)
UDI:
40198459143596
40195327580118
10198459143595
10195327580117

Recall #: Z-1366-2025; Quantity: 506 units.

Product: Proxima Drape FACE LIFT
Model / REF:
DYNJ910462
Lot Numbers:
24JMD608 (Exp 06/30/2026)
UDI:
40195327695638
10195327695637

Recall #: Z-1367-2025; Quantity: 16 units.

Product: Proxima Drape Specialized Procedure Packs (Shoulder, Hip, Extremity, Neck, Vein)
Variants: HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK
Model / REF:
DYNJ35520B
DYNJ38529F
DYNJ43406F
DYNJ43421D
DYNJ69185A
DYNJ69340B
DYNJ88923
Lot Numbers:
24KMB843 (Exp 05/31/2027)
24IMD400 (Exp 01/31/2027)
24IMB784 (Exp 01/31/2027)
24LBK460 (Exp 02/28/2027)
24JBY288 (Exp 12/31/2026)
24LBJ155 (Exp 01/31/2027)
24JBU154 (Exp 12/31/2026)
24HBP361 (Exp 11/30/2026)
24HBA919 (Exp 10/31/2026)
24JBX700 (Exp 06/30/2026)
24JBC370 (Exp 04/30/2026)
24IBI711 (Exp 04/30/2026)
24HBO453 (Exp 04/30/2026)
24HBA954 (Exp 01/31/2026)
24JBK365 (Exp 04/30/2026)
24HBR810 (Exp 04/30/2026)
24GBX503 (Exp 03/31/2026)
24LBO297 (Exp 06/30/2026)
24JBV432 (Exp 06/30/2026)
24IBU974 (Exp 05/31/2026)
24HBR072 (Exp 04/30/2026)
25ABB569 (Exp 02/10/2026)
UDI:
40198459106904
40195327693870
40198459074005
40198459074784
40195327582839
40198459026127
40198459216856
10198459106903
10195327693879
10198459074004
10198459074783
10195327582838
10198459026126
10198459216855

Recall #: Z-1368-2025; Quantity: 2,422 units.

Product: Proxima Drape UNIVERSAL DAVINCI ROBOTIC P
Model / REF:
DYNJ53968P
Lot Numbers:
24KMC372 (Exp 3/31/2026)
24IMJ082 (Exp 4/30/2026)
24HMK377 (Exp 4/30/2026)
UDI:
40195327532759
10195327532758

Recall #: Z-1369-2025; Quantity: 220 units.

Product: Proxima Drape Orthopedic and Spine Procedure Packs
Variants: ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL KNEE, SPINE
Model / REF:
CDS985210G
DYNJ65826A
DYNJ87398
DYNJ908743C
DYNJ908744C
DYNJ910326B
Lot Numbers:
24LBK011 (Exp 04/30/2026)
24JBR548 (Exp 02/28/2026)
24IBN166 (Exp 02/28/2026)
24KMF425 (Exp 06/30/2026)
24JMI243 (Exp 06/30/2026)
24IMI316 (Exp 05/31/2026)
24HMH127 (Exp 04/30/2026)
24JBW476 (Exp 02/28/2026)
24HBK163 (Exp 02/28/2026)
24KBA490 (Exp 02/28/2026)
24JBM980 (Exp 02/28/2026)
24JBB973 (Exp 02/28/2026)
24IBQ750 (Exp 03/31/2026)
24JBM981 (Exp 02/28/2026)
24JBH713 (Exp 02/28/2026)
24HBJ792 (Exp 02/28/2026)
24KBQ357 (Exp 12/31/2025)
UDI:
40195327553310
40195327516193
40198459034405
40195327636297
40195327636280
40198459075002
10195327553319
10195327516192
10198459034404
10195327636296
10195327636289
10198459075001

Recall #: Z-1370-2025; Quantity: 1,118 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96401
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries, LP; Authorized medical supply distributors
Manufactured In: United States
Units Affected: 8 products (1,482 units; 1,490 units; 114 units; 506 units; 16 units; 2,422 units; 220 units; 1,118 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.