Sterile Surgical Drape Recalled Due to Potential Packaging Breach
Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were 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: This is a risk-of-harm product (sterile surgical drape where sterility is critical to patient safety). A packaging breach could allow contamination and compromise the drape's intended function. However, the hazard is potential and theoretical with no reported illnesses or injuries, placing this at the maximum score of 3 per the rubric.
Plain-English summary
Medline Industries, LP is recalling Proxima Drape labeled as ENT-PLASTICS PACK, a sterile surgical drape used in medical procedures. The recall was initiated because of a potential breach in the pouch packaging that could lead to loss of sterility.
The affected product consists of 114 units that were distributed nationwide. The recalled items have specific lot numbers and universal device identifiers (UDI) listed by the FDA: Item No. DYNJ84258A & DYNJ84258B; Case UDI: 40195327650743 & 40198459117986; Each UDI: 10195327650742 & 10198459117985; Lot numbers 24HBK264 (expiring 12/31/26) and 24IBD271 (expiring 7/31/26).
Consumers and healthcare facilities that have received this product should immediately discontinue use and contact Medline Industries. Healthcare providers should verify whether any of the affected drapes were used in patient care. Although no illnesses or injuries have been reported, use of a compromised sterile drape could pose a risk to patients.
The recalled product
- Product
- Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 114
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. DYNJ84258A & DYNJ84258B
- UDI (case): 40195327650743 & 40198459117986
- UDI (each): 10195327650742 & 10198459117985
- Lot No. (Shelf Life) 24HBK264 (12/31/26) & 24IBD271 (7/31/26). .
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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