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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 506
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.
Part of a larger recall action
This product is one of 8 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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