---
title: "DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15 — FDA record Z-0561-2023 | Is It on Recall"
description: "DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled."
url: https://isitonrecall.com/recall/fda-device-z-0561-2023-deroyal-major-oral-pack-rf-ref-89-3936-15/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15 — FDA record Z-0561-2023

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 Nov 3, 2022. 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**: DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
- **Reason**: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
- **Classification**: Class II
- **Recalling firm**: DeRoyal Industries Inc
- **Quantity**: 828 kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0561-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0561-2023%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 | Lot Numbers: Lot 56185163 exp 2/1/2024; Lot 56390466 exp 2/1/2024; Lot 56616859 exp 2/1/2024; Lot 57390901 exp 1/1/2024; Lot 57466813 exp 10/1/2024; Lot 57589987 exp 6/1/2024; Lot 57674444 exp 6/1/2024 |

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

## Distribution

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

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

- [Alabama](https://isitonrecall.com/state/alabama/)
- [Arizona](https://isitonrecall.com/state/arizona/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)

## Dates in the source

- **Report date**: Dec 21, 2022
- **Recall initiation date**: Nov 3, 2022
- **Center classification date**: Dec 15, 2022

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-0561-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [DeRoyal Industries Inc records](https://isitonrecall.com/brand/deroyal-industries-inc/)