Sterile surgical drapes recalled due to potential packaging breach
Medline Industries is recalling 220 Proxima Drape sterile surgical drapes nationwide due to a potential breach in pouch packaging that could compromise sterility.
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 FDA Class II recall involves a potential packaging breach that could lead to loss of sterility in a surgical device. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed. Per the rubric, when no illnesses are reported and the hazard is theoretical, the score is at most 3. The product poses a risk of harm (loss of sterility), justifying a High severity classification.
Plain-English summary
Medline Industries, LP is recalling 220 units of Proxima Drape sterile surgical drapes labeled as UNIVERSAL DAVINCI ROBOTIC P. The affected lot numbers are 24KMC372 (shelf life 3/31/2026), 24IMJ082 (shelf life 4/30/2026), and 24HMK377 (shelf life 4/30/2026).
The recall is due to a potential breach in the pouch packaging that could result in loss of sterility.
The affected drapes were distributed nationwide. No illnesses or injuries have been reported.
Healthcare providers with the affected drapes should stop using them and contact Medline Industries for replacement or disposal instructions.
The recalled product
- Product
- Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Drapes
- Affected units
- 220
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 (6)
- Item No. DYNJ53968P
- UDI (case): 40195327532759
- UDI (each): 10195327532758
- Lot No. (Shelf Life) 24KMC372 (3/31/2026)
- 24IMJ082 (4/30/2026)
- 24HMK377 (4/30/2026). .
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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