FDA Device recall Z-1689-2024
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery by Baxter Healthcare, citing product was distributed in the United States without proper regulatory approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1689-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-15 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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.
Identifiers
| code_info | UDI/DI 05413765588310, Lot Number DBYSEP046 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1689-2024%22
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