The Recall Desk
HighFDA (Devices)·Z-1370-2025·Announced 2025-03-26

Surgical drapes recalled due to potential sterility breach in packaging

Medline Industries is recalling Proxima Drape surgical drapes nationwide due to a potential breach in pouch packaging that could lead to loss of sterility. The recall affects 1,118 units distributed in the US.

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 an FDA Class II device recall involving a potential breach in sterile packaging. The hazard—loss of sterility in surgical drapes—is serious and could affect surgical safety, but no illnesses or injuries have been reported. Per the rubric, this constitutes a 'risk-of-harm product where injury has not yet been reported,' warranting a High severity score.

Plain-English summary

Medline Industries, LP is recalling Proxima Drape surgical drapes distributed throughout the United States. The affected product includes drapes labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, and SPINE variants. Approximately 1,118 units have been distributed nationwide.

The recall was initiated due to a potential breach in the pouch packaging which could lead to loss of sterility of the surgical drapes.

Healthcare facilities and surgical centers that received affected drapes should verify their inventory using the item numbers and lot numbers provided. Affected products include Item Nos. CDS985210G, DYNJ65826A, DYNJ87398, DYNJ908743C, DYNJ908744C, and DYNJ910326B, with lot numbers and expiration dates listed in the recall notice.

Facilities should discontinue use of affected drapes and contact Medline Industries for instructions regarding product return or replacement.

The recalled product

Product
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Drapes
Hazard
  • sterility-loss

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. CDS985210G
  • CDS985210G
  • DYNJ65826A
  • DYNJ87398
  • DYNJ908743C
  • 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)

Distribution

Distributed nationwide across the United States.

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