The Recall Desk
HighFDA (Devices)·Z-1368-2025·Announced 2025-03-26

Proxima Drape sterile drapes recalled for potential packaging breach risk

Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. The recall affects 2,422 units distributed nationwide.

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: FDA Class II medical device recall for potential sterility breach in surgical drapes. Per the rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).

Plain-English summary

Medline Industries, LP is recalling Proxima Drape sterile surgical drapes in multiple configurations, including HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, and VEIN PACK. A total of 2,422 units have been identified as subject to this recall.

The recall was issued because of a potential breach in the pouch packaging of these drapes. A breach in the sterile packaging could lead to loss of sterility, which could compromise the safety and effectiveness of the surgical drapes if used in sterile procedures.

The affected drapes were distributed nationwide throughout the United States. Healthcare facilities and surgical centers that received these products should check the lot numbers and UDI codes in the FDA's recall notice.

Consumers and healthcare facilities should stop using the affected products immediately and contact Medline Industries for instructions on return or disposal.

The recalled product

Product
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.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Drape
Hazard
  • loss-of-sterility
  • packaging-breach

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. DYNJ35520B
  • DYNJ38529F
  • DYNJ43406F
  • DYNJ43421D
  • DYNJ69185A
  • DYNJ69340B
  • DYNJ88923
  • UDI (case): 40198459106904
  • 40195327693870
  • 40198459074005
  • 40198459074784
  • 40195327582839
  • 40198459026127
  • 40198459216856
  • UDI (each): 10198459106903
  • 10195327693879
  • 10198459074004
  • 10198459074783
  • 10195327582838
  • 10198459026126

Distribution

Distributed nationwide across the United States.

Related recalls

Same category