Ameda, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1326-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.

Product Classification:

Class II

Date Initiated: February 12, 2015

Date Posted: April 1, 2015

Recall Number: Z-1326-2015

Event ID: 70599

Reason for Recall:

Devices were not sterilized

Status: Terminated

Product Quantity: 1763

Code Information:

SKU 17161; Lot 5A22

Distribution Pattern:

Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WA.

Voluntary or Mandated:

Voluntary: Firm initiated