The Recall Desk
HighFDA (Devices)·Z-1367-2025·Announced 2025-03-26

Medline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk

Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 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 recall for sterile surgical drape with potential packaging breach leading to loss of sterility. No illnesses or injuries reported, placing this in the risk-of-harm products category where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling Proxima Drape sterile surgical drapes labeled as FACE LIFT. The product is a sterile surgical drape.

The recall is due to a potential breach in the pouch packaging that could result in loss of sterility.

The affected product consists of 16 units with lot number 24JMD608 (shelf life expiration 06/30/2026) that were distributed nationwide throughout the United States.

Persons who have received the recalled product should contact Medline Industries, LP for further information.

The recalled product

Product
Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • sterility-loss
  • contamination-risk

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 (4)

  • Item No.DYNJ910462
  • UDI (case): 40195327695638
  • UDI (each): 10195327695637
  • Lot No. (Shelf Life) 24JMD608 (06/30/2026).

Distribution

Distributed nationwide across the United States.