Z-1326-2015Class II

Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63...

Name: Z-1326-2015 Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63...
Creator: Ameda, Inc.
Published: 2015-02-12
License: https://open.fda.gov/license/

Ameda, Inc. / initiated 2015-02-12 / Terminated / root cause: sterility

FDA source

Ameda, Inc. began a recall of 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... on 2015-02-12. FDA classified it as Class II and gives the reason as "Devices were not sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1326-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-12
Posted: 2015-03-26
Terminated: 2017-07-21
Recalling firm: Ameda, Inc.
Product: 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 code: HGY Pump, Breast, Non-Powered
Reason for recall: Devices were not sterilized
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Ameda sent an URGENT: MEDICAL DEVICE RECALL letter dated February 12, 2015 to all affected customers. The letter included instructions for distributors to: 1) quarantine the recalled products; 2) complete and return the enclosed Recall Response Forms within 3 days of receiving the letter; 3) upon receipt of the completed Recall Response Form, an Ameda representative would contact the distributor to make arrangements for the return of the recalled products; 4) Ameda will use the information provided in the returned Recall Response Form to contact the distributor's customers of record to arrange for the return of recalled product that was already shipped to the customers of record; and, 5) replacement product will be shipped to both distributors and their customers of record upon receipt of the completed Recall Response Form. Questions about this recall will be answered by Ameda personnel who can be reached at 847-964-2645.
Quantity in commerce: 1763
Distribution: 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.
Product codes and lots: SKU 17161; Lot 5A22

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1326-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1326-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-26
Z-1327-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-26

Product code HGY

K912355Class IMothers Touch One Hand Breast PumpHollister, Inc. / cleared 1993-12-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)