FDA Device recall Z-1697-2022
Breast Abdominoplasty Pack
- FDA Device
- Class II
- ongoing
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of Breast Abdominoplasty Pack by American Contract Systems, citing product was exposed to multiple sterilization cycles without validation for multiple exposures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1697-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-16 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | American Contract Systems |
| Distribution | AZ, FL, IA, IL, MA, MN, MO, NE, OH, PA, RI, SD, TX |
Product
Breast Abdominoplasty Pack
Reason
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Identifiers
| code_info | Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) SWBA26F, 2106091, 842211, 64133051-006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1697-2022%22
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