The Recall Desk
HighFDA (Devices)·Z-1363-2025·Announced 2025-03-26

Medline Proxima sterile surgical drapes recalled due to potential packaging breach

Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a potential packaging breach of sterile surgical drapes with no reported illnesses or injuries. As a risk-of-harm medical device where injury has not yet been reported, it meets the High (3) severity criterion.

Plain-English summary

Medline Industries, LP is recalling 1,482 units of Proxima sterile surgical drapes that were distributed nationwide. The Proxima Drape product line includes multiple configurations designed for different surgical procedures, including cesarean sections, laparoscopic cholecystectomy, abdominal surgery, orthopedic procedures, and robotic surgery.

The recall was initiated due to a potential breach in pouch packaging that could lead to loss of sterility. Breaches in sterile packaging can compromise the sterile barrier that protects surgical drapes from contamination.

The affected products were distributed across the United States to healthcare facilities and surgical centers. These facilities should verify the status of any Proxima Drape products they may have received.

Facilities that have received these drapes should contact Medline Industries for guidance regarding the specific lot numbers and item numbers involved in this recall.

The recalled product

Product
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; DRA
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Drapes
Hazard
Affected units
1,482

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Item No. DYNJCDCSEC01
  • DYNJP2498
  • DYNJP3102A
  • DYNJP3103
  • DYNJP4014
  • DYNJP4015
  • DYNJP4124
  • DYNJP6108
  • DYNJP8005UG
  • DYNJP8303
  • DYNJP8304A
  • DYNJP9108
  • UDI (case): 40888277367679
  • 40080196739494
  • 40080196778363
  • 40080196744221
  • 40080196287308
  • 40080196770039
  • 40080196164944
  • 20888277668840

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · packaging breach

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