AMS 700 100 mL — Class II medical device recall Z-2045-2020
Terminated recall by Boston Scientific Corporation, reported 2020-05-27, distributed nationwide. A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100m
| Recall number | Z-2045-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2019-12-17 |
| Classified | 2020-05-19 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2020-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| Reason classes | labeling |
| Lot numbers | 24464037 |
| Model numbers | 72404156 |
Product
AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
Reason for recall
A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
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-2045-2020. 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.