FDA recall, , Moderate risk
Philips Avalon Fetal Monitor
The Philips Avalon Fetal Monitor has incorrect speaker connector assembly that can cause loss of speaker output.
Summary by Recall Canary from the FDA notice
What happened
Philips North America Llc of Cambridge, Massachusetts, began a recall on May 26, 2026, for its Philips Avalon Fetal Monitor, FM20, and Philips Avalon Fetal Monitor, FM 30, because the 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.
The FDA added the recall to its Enforcement Report on June 22, 2026, with worldwide distribution including the US nationwide and other countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
- UDI-DI
- 00884838000407
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
- UDI-DI
- 00884838000414
Recall details
- Company began the recall
- Sold in
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.
- Company
- Philips North America LlcCambridge, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99084
- Recall numbers
- Z-2522-2026 to Z-2523-2026
All recalls from Philips North America Llc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
