The Recall Desk
HighFDA (Devices)·Z-1364-2025·Announced 2025-03-26

Surgical Drape Packs Recalled for Potential Sterility Breach in Packaging

Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 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: The recall addresses a potential breach in sterile surgical drape packaging that could lead to loss of sterility. No illnesses or injuries have been reported. This meets the High severity criterion as a risk-of-harm medical device where injury has not yet been reported.

Plain-English summary

Medline Industries, LP (Northfield) is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The affected drapes include various surgical configurations such as basic drapes, IV drapes, setups without drapes, universal drapes, laparotomy packs, and cystoscopy packs used in operating rooms and surgical settings.

The recall affects 1,490 units distributed nationwide. The affected products are identified by item numbers DYNJP1020S, DYNJP1025S, DYNJP1040, DYNJP1055S, DYNJP3000, DYNJP5050, DYNJP6060S, and DYNJP9120A, with specific lot numbers 31124090044H, 31124090028F, 31124080024F, 31124080061F, 31124090029F, 31124090089F, 31124100077F, 31124090030H, 31124090054F, 31124070070F, 31124080063F, 45024090166, and 31124100007F.

No illnesses or injuries have been reported to date in connection with this recall. Healthcare facilities should verify whether they have received the affected lot numbers and ensure that any such products are not used in surgical procedures.

The recalled product

Product
Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PAC
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Drapes
Hazard
  • sterility-breach
  • 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 (20)

  • Item No. DYNJP1020S
  • DYNJP1025S
  • DYNJP1040
  • DYNJP1055S
  • DYNJP3000
  • DYNJP5050
  • DYNJP6060S
  • DYNJP9120A
  • UDI (case): 40080196308126
  • 40080196308133
  • 40080196722892
  • 40080196308195
  • 40080196722946
  • 40080196753391
  • 40884389110295
  • 40080196915416
  • UDI (each): 10080196308125
  • 10080196308132
  • 10080196722891
  • 10080196308194

Distribution

Distributed nationwide across the United States.

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