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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
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