Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-1516-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.

Product Classification:

Class II

Date Initiated: March 31, 2021

Date Posted: May 5, 2021

Recall Number: Z-1516-2021

Event ID: 87642

Reason for Recall:

The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.

Status: Terminated

Product Quantity: 250 units

Code Information:

Device Model Number: 11-1122; Lot Number: 3809856

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of PA and MN. The countries of Columbia, Germany, Greece, Hong Kong, Qatar, Thailand, and United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated