Class II — Ameda, Inc.
| Recalling firm | Ameda, Inc. |
|---|---|
| Registered facility | Ameda, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Devices were not sterilized |
| 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. |
| Quantity | 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. |
| Initiated | 2015-02-12 |
| Classified | 2015-03-26 |
| Terminated | 2017-07-21 |
| Recall number | Z-1326-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ameda, Inc. (Z-1326-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70599/
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