FDA Device recall Z-0531-2025
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O by Boston Scientific, citing potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0531-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-28 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Reason
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Identifiers
| code_info | UPN Number: 72400024. GTIN Number: 00878953000626. Lot Numbers: 32500739, 32500821, 32500820. Serial Numbers: 110036608…UPN Number: 72400024. GTIN Number: 00878953000626. Lot Numbers: 32500739, 32500821, 32500820. Serial Numbers: 1100366088, 1100366115, 1100366089, 1100366116, 1100366090, 1100366117, 1100366091, 1100366118, 1100366092, 1100366119, 1100366093, 1100366120, 1100366094, 1100366121, 1100366095, 1100366122, 1100366096, 1100366123, 1100366097, 1100366144, 1100366098, 1100366145, 1100366099, 1100366146, 1100366100, 1100366147, 1100366101, 1100366148, 1100366102, 1100366149, 1100366103, 1100366150, 1100366104, 1100366151, 1100366105, 1100366152, 1100366106, 1100366153, 1100366107, 1100366154, 1100366108, 1100366155, 1100366109, 1100366156, 1100366110, 1100366157, 1100366111, 1100366158, 1100366112, 1100366159, 1100366113, 1100366160, 1100366114. Expiration Date: 09/23/2028 |
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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-0531-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.