Ameda One-Hand Manual Breast Pump — Class II medical device recall Z-1326-2015
Terminated recall by Ameda, Inc., reported 2015-04-01, distributed nationwide. Devices were not sterilized
| Recall number | Z-1326-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ameda, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2015-02-12 |
| Classified | 2015-03-26 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2017-07-21 |
| Distributed | Nationwide (US) |
| Quantity | 1,763 |
| Lot numbers | 5A22 |
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.
Reason for recall
Devices were not sterilized
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-1326-2015. 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.