The Recall Desk
ModerateFDA (Devices)·Z-2045-2020·Announced 2020-05-27

Boston Scientific Recalls AMS 700 Reservoirs Due to Labeling Error

Boston Scientific is recalling five AMS 700 100 mL Spherical Reservoirs with InhibiZone because they were incorrectly labeled as a different model.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error without reported injuries or illnesses, fitting the Moderate severity criteria.

Plain-English summary

Boston Scientific Corporation is recalling five units of the AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156. The recall is due to a labeling discrepancy where the product was incorrectly labeled as the AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone.

The affected devices are intended for use in the treatment of chronic, organic, male erectile dysfunction. The recall covers Lot 24464037. The products were distributed nationwide in the United States, including in the states of California, Maryland, North Carolina, Nevada, and Texas.

Consumers and healthcare providers should stop using the affected devices and contact Boston Scientific Corporation for further instructions.

The recalled product

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).
Affected units
5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 24464037

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically: