AMS Artificial Urinary Sphincter Control Pump — Class II medical device recall Z-0530-2025
Ongoing recall by Boston Scientific Corporation, reported 2024-12-04, distributed nationwide. Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) w
| Recall number | Z-0530-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2024-10-28 |
| Classified | 2024-11-25 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CH, CL, CN, CR, CZ, DE, ES, FI, FR, IE, KR, NL, PL, SE, TW |
| Quantity | 16 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00878953000688 |
| Lot numbers | 32487464 |
| Serial numbers | 1100366307, 1100366309, 1100366310, 1100366311, 1100366312, 1100366313, 1100366314, 1100366315, 1100366316, 1100366317, 1100366319, 1100366320, 1100366321, 1100366323, 1100366324, 1100366325 |
| Expiration dates | 2028-09-24 |
Product
AMS Artificial Urinary Sphincter Control Pump
Reason for recall
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0530-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.