CLASS II ONGOING Device recall · Reported 1 Jul 2026 · FDA Enforcement Report

Philips Avalon Fetal Monitor, FM20 recalled by Philips North America

Philips North America is recalling Philips Avalon Fetal Monitor, FM20, distributed nationwide in the US. The recall was initiated on 26 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 00884838000407, Serial Numbers: DE79569306, DE79569332, DE79569360, DE79569417, DE79569442, DE79569482, DE79569307, DE79569470, DE79569390, DE79569356, DE79569452, DE79569289, DE79569302, DE79569536, DE79569358, DE79569343, DE79569457, DE79569353, DE79569373, DE79569411, DE79569491, DE79569615, DE79569287, DE79569338, DE79569437, DE79569459, DE79569473, DE79569340, DE79569308, DE79569377, DE79569286, DE79569304, DE79569327, DE79569330, DE79569347, DE79569352, DE79569400, DE79569418, DE79569431, DE79569436, DE79569456, DE79569469, DE79569474, DE79569588, DE79569326, DE79569424, DE79569487, DE79569547, DE79569290, DE79569258, DE79569367, DE79569370, DE79569380, DE79569388, DE79569311, DE79569440, DE79569460, DE79569527, DE79569462, DE79569299, DE79569261, DE79569405, DE79569260, DE79569313, DE79569369, DE79569216,

Quantity recalled285 units

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-2522-2026
FDA event ID: 99084
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 26 May 2026
FDA classified: 22 Jun 2026
Reported: 1 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

26 May 2026	Recall initiated by company
22 Jun 2026	Classified by FDA	+27 days
1 Jul 2026	Published in enforcement report	+9 days

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

Reason for recall

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

Product as listed by the FDA

Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

Where it was distributed

Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, LV, MX, MY, NL, NZ, OM, SA, SE, SG, SI, TR, TW, ZA.

Nationwide California Delaware Idaho Illinois Indiana

Questions about this recall

Why was it recalled?

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

Which lots are affected?

UDI/DI 00884838000407, Serial Numbers: DE79569306, DE79569332, DE79569360, DE79569417, DE79569442, DE79569482, DE79569307, DE79569470, DE79569390, DE79569356, DE79569452, DE79569289, DE79569302, DE79569536, DE79569358, DE79569343, DE79569457, DE79569353, DE79569373, DE79569411, DE79569491, DE79569615, DE79569287, DE79569338, DE79569437, DE79569459, DE79569473, DE79569340, DE79569308, DE79569377, DE79569286, DE79569304, DE79569327, DE79569330, DE79569347, DE79569352, DE79569400, DE79569418, DE79569431, DE79569436, DE79569456, DE79569469, DE79569474, DE79569588, DE79569326, DE79569424, DE79569487, DE79569547, DE79569290, DE79569258, DE79569367, DE79569370, DE79569380, DE79569388, DE79569311, DE79569440, DE79569460, DE79569527, DE79569462, DE79569299, DE79569261, DE79569405, DE79569260, DE79569313, DE79569369, DE79569216,

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99084

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026	CLASS II	Philips Avalon Fetal Monitor, FM 30 Part numberM2703A recalled	Philips North America	Other	Nationwide

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