---
title: "Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in ... — FDA record Z-1689-2024 | Is It on Recall"
description: "Product was distributed in the United States without proper regulatory approval."
url: https://isitonrecall.com/recall/fda-device-z-1689-2024-baxter-seprafilm-adhesion-barrier-1-half-sheet-5-pk-ref-664103-for-use-in-abdominal-and-pelvic-surge/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery — FDA record Z-1689-2024

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 Mar 15, 2024. 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**: Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
- **Reason**: Product was distributed in the United States without proper regulatory approval.
- **Classification**: Class II
- **Recalling firm**: Baxter Healthcare Corporation
- **Quantity**: 165 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1689-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1689-2024%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 | UDI/DI 05413765588310, Lot Number DBYSEP046 |

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

## Distribution

US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.

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

- [Alaska](https://isitonrecall.com/state/alaska/)
- [Alabama](https://isitonrecall.com/state/alabama/)
- [Arkansas](https://isitonrecall.com/state/arkansas/)
- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Delaware](https://isitonrecall.com/state/delaware/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Hawaii](https://isitonrecall.com/state/hawaii/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Idaho](https://isitonrecall.com/state/idaho/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Maine](https://isitonrecall.com/state/maine/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [Montana](https://isitonrecall.com/state/montana/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [North Dakota](https://isitonrecall.com/state/north-dakota/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
- [New Hampshire](https://isitonrecall.com/state/new-hampshire/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New Mexico](https://isitonrecall.com/state/new-mexico/)
- [Nevada](https://isitonrecall.com/state/nevada/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Rhode Island](https://isitonrecall.com/state/rhode-island/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [South Dakota](https://isitonrecall.com/state/south-dakota/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Vermont](https://isitonrecall.com/state/vermont/)
- [Washington](https://isitonrecall.com/state/washington/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)
- [Wyoming](https://isitonrecall.com/state/wyoming/)

## Dates in the source

- **Report date**: May 1, 2024
- **Recall initiation date**: Mar 15, 2024
- **Center classification date**: Apr 25, 2024

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-1689-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Baxter Healthcare Corporation records](https://isitonrecall.com/brand/baxter-healthcare-corporation/)