Data Foundry

Medical device recalls 2024

AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm… — Class II medical device recall Z-0531-2025

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 numberZ-0531-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBoston Scientific Corporation, Marlborough, MA, United States
Recall initiated2024-10-28
Classified2024-11-25
Reported by FDA2024-12-04
DistributedNationwide (US)
Countries outside the USAR, AT, AU, BE, CH, CL, CN, CR, CZ, DE, ES, FI, FR, IE, KR, NL, PL, SE, TW
Quantity52 units
Reason classeslabeling
UPC / GTIN / UDI-DI00878953000626
Lot numbers32500739, 32500820, 32500821
Serial numbers1100366088, 1100366089, 1100366090, 1100366091, 1100366092, 1100366093, 1100366094, 1100366095, 1100366096, 1100366097, 1100366098, 1100366099, 1100366100, 1100366101, 1100366102, 1100366103, 1100366104, 1100366105, 1100366106, 1100366107, 1100366108, 1100366109, 1100366110, 1100366111, 1100366112 and 28 more
Expiration dates2028-09-23

Product

AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O

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-0531-2025. 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.