The Recall Desk
HighFDA (Devices)·Z-1366-2025·Announced 2025-03-26

Proxima Drape surgical drapes recalled due to potential sterility loss

Medline Industries recalls 506 units of Proxima Drape surgical drapes nationwide due to potential packaging breaches that could compromise sterility. Affected drapes were labeled as MINOR PACK or LAPAROSCOPY variants.

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 recall of a medical device with a potential packaging defect that could compromise sterility. The hazard is described as potential rather than confirmed. Per the rubric, recalls involving theoretical hazards and risk-of-harm products score at 3 (High).

Plain-English summary

Medline Industries, LP has recalled 506 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could result in loss of sterility. The product was distributed nationwide and is available in MINOR PACK (Item No. DYNJ34603F) and LAPAROSCOPY (Item No. DYNJ903916I) variants.

Affected lot numbers include 25AMD464, 24JMC011, 25ABA362, 24KBT718, 24JBE997, and 24IBM203, with expiration dates ranging from February 2026 through November 2029. The FDA classified this as a Class II recall (Z-1366-2025).

The recalled product

Product
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Drape
Hazard
  • packaging-breach
  • loss-of-sterility

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 (9)

  • Item No. DYNJ34603F & DYNJ903916I
  • UDI (case): 40198459143596 & 40195327580118
  • UDI (each): 10198459143595 & 10195327580117
  • Lot No. (Shelf Life) 25AMD464(11/30/2029)
  • 24JMC011(04/30/2029)
  • 25ABA362(09/30/2025)
  • 24KBT718(02/28/2026)
  • 24JBE997(09/30/2025)
  • 24IBM203(02/28/2026).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category