Medline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk
Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 units distributed nationwide.
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: FDA Class II recall for sterile surgical drape with potential packaging breach leading to loss of sterility. No illnesses or injuries reported, placing this in the risk-of-harm products category where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling Proxima Drape sterile surgical drapes labeled as FACE LIFT. The product is a sterile surgical drape.
The recall is due to a potential breach in the pouch packaging that could result in loss of sterility.
The affected product consists of 16 units with lot number 24JMD608 (shelf life expiration 06/30/2026) that were distributed nationwide throughout the United States.
Persons who have received the recalled product should contact Medline Industries, LP for further information.
The recalled product
- Product
- Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Drapes
- Affected units
- 16
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 (4)
- Item No.DYNJ910462
- UDI (case): 40195327695638
- UDI (each): 10195327695637
- Lot No. (Shelf Life) 24JMD608 (06/30/2026).
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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