CLASS III ONGOING Device recall · Reported 21 Feb 2018 · FDA Enforcement Report

Purely Yours Breast Pump recalled by AMEDA

AMEDA is recalling Purely Yours Breast Pump, distributed in 14 states. The recall was initiated on 10 Jul 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot 7E058 and Lot 7E308

Quantity recalled3,327 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0616-2018
FDA event ID: 78237
Recalling firm: AMEDA, Buffalo Grove, IL
Classification: Class III
Status: Ongoing
Recall initiated: 10 Jul 2017
FDA classified: 15 Feb 2018
Reported: 21 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Jul 2017	Recall initiated by company
15 Feb 2018	Classified by FDA	+220 days
21 Feb 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Two specific lots was incorrectly manufactured containing a UK power adapter.

Product as listed by the FDA

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.

Where it was distributed

Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.

California District of Columbia Delaware Florida Georgia Illinois Maryland North Carolina New Jersey Ohio Texas Utah Virginia Washington

Questions about this recall

Is Purely Yours Breast Pump recalled?

Yes. AMEDA recalled Purely Yours Breast Pump on 10 Jul 2017. The recall is Class III and its status is Ongoing. Recall number Z-0616-2018.

Why was it recalled?

Two specific lots was incorrectly manufactured containing a UK power adapter.

Which lots are affected?

Lot 7E058 and Lot 7E308

Where was it sold?

Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from AMEDA

All 3

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1 Apr 2015Device	CLASS II	Dual Short Term HygieniKit Milk Collections System recalled by Ameda	Ameda	Sterility	Nationwide

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