The Recall Desk
HighFDA (Devices)·Z-1326-2015·Announced 2015-04-01

Ameda One-Hand Manual Breast Pump Recalled for Lack of Sterilization

Ameda, Inc. is recalling 1,763 units of the One-Hand Manual Breast Pump (SKU 17161) because the devices were not sterilized.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that was not sterilized, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Ameda, Inc. is recalling 1,763 units of the Ameda One-Hand Manual Breast Pump (SKU 17161). The recall is due to the devices not being sterilized. The affected product is identified by Lot 5A22.

The recalled breast pumps were distributed nationwide, including in California, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington.

Consumers who have this product should stop using it and contact Ameda, Inc. for instructions on how to proceed.

The recalled product

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.
Manufacturer
Ameda, Inc.
Category
Medical Device — Breast Pump
Hazard
Affected units
1,763

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • SKU 17161
  • Lot 5A22

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Ameda, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Ameda, Inc.

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Same hazard · infection risk

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