---
title: "Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape. — FDA record Z-1365-2025 | Is It on Recall"
description: "Potential breach in pouch packaging which could lead to loss of sterility."
url: https://isitonrecall.com/recall/fda-device-z-1365-2025-proxima-drape-labeled-as-ent-plastics-pack-sterile-surgical-drape/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape. — FDA record Z-1365-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 13, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
- **Reason**: Potential breach in pouch packaging which could lead to loss of sterility.
- **Classification**: Class II
- **Recalling firm**: MEDLINE INDUSTRIES, LP - Northfield
- **Quantity**: 114 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1365-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1365-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Item No. DYNJ84258A & DYNJ84258B; UDI (case): 40195327650743 & 40198459117986; UDI (each): 10195327650742 & 10198459117985; Lot No. (Shelf Life) 24HBK264 (12/31/26) & 24IBD271 (7/31/26). . |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US Nationwide distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

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- [Oregon](https://isitonrecall.com/state/oregon/)
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- [South Dakota](https://isitonrecall.com/state/south-dakota/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
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- [Utah](https://isitonrecall.com/state/utah/)
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- [Wyoming](https://isitonrecall.com/state/wyoming/)

## Dates in the source

- **Report date**: Mar 26, 2025
- **Recall initiation date**: Feb 13, 2025
- **Center classification date**: Mar 14, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1365-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [MEDLINE INDUSTRIES, LP - Northfield records](https://isitonrecall.com/brand/medline-industries-lp-northfield/)