Purely Yours Breast Pump — Class III medical device recall Z-0616-2018
Ongoing recall by AMEDA, INC., reported 2018-02-21, distributed in CA, DC, DE, FL, GA, IL, MD, NC…. Two specific lots was incorrectly manufactured containing a UK power adapter.
| Recall number | Z-0616-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMEDA, INC., Buffalo Grove, IL, United States |
| Recall initiated | 2017-07-10 |
| Classified | 2018-02-15 |
| Reported by FDA | 2018-02-21 |
| Distributed | CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, WA |
| Quantity | 3,327 units |
| Lot numbers | 7E058, 7E308 |
| Model numbers | 17070ACA, 17070PMW |
Product
Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.
Reason for recall
Two specific lots was incorrectly manufactured containing a UK power adapter.
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-0616-2018. 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.