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Phonak Sky L90-UP (precious pink)Recalls & reported problems

Sonova AG · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613389633559), received between Mar 24, 2025 and Mar 24, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Improper or Incorrect Procedure or Method2
  • Insufficient Device Problem Information2

Patient problems

  • Foreign Body In Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 24, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

    THE PATIENT IS AN 18-MONTH-OLD GIRL WHO WAS USING PHONAK SKY L90-UP HEARING AIDS WITH TAMPER-PROOF BATTERY DOORS AND ZINC-AIR BATTERY. IT HAS BEEN REPORTED TO THE MANUFACTURER THAT THE PATIENT HAS MANAGED TO OPEN THE BATTERY DOOR AND SWALLOWED A SINGLE BUTTON CELL BATTERY ON TWO SEPARATE OCCASIONS ((B)(6) 2025 AND (B)(6) 2025). BOTH TIMES A SINGLE BATTERY WAS IDENTIFIED ON THE X-RAY IN THE PATIENT'S STOMACH. DURING THE SECOND INCIDENT, ONE BATTERY WAS INGESTED BUT THE OTHER WAS FOUND IN HER MOUTH BEFORE IT COULD BE INGESTED. THE BATTERIES EXITED PATIENT'S SYSTEM AND THE PATIENT DID NOT EXPERIENCE ANY HARM DUE TO THIS INCIDENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 21676661 ↗
  • InjuryMar 24, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

    THE PATIENT IS AN 18-MONTH-OLD GIRL WHO WAS USING PHONAK SKY L90-UP HEARING AIDS WITH TAMPER-PROOF BATTERY DOORS AND ZINC-AIR BATTERY. IT HAS BEEN REPORTED TO THE MANUFACTURER THAT THE PATIENT HAS MANAGED TO OPEN THE BATTERY DOOR AND SWALLOWED A SINGLE BUTTON CELL BATTERY ON TWO SEPARATE OCCASIONS ((B)(6) 2025 AND (B)(6) 2025). BOTH TIMES A SINGLE BATTERY WAS IDENTIFIED ON THE X-RAY IN THE PATIENT'S STOMACH. DURING THE SECOND INCIDENT, ONE BATTERY WAS INGESTED BUT THE OTHER WAS FOUND IN HER MOUTH BEFORE IT COULD BE INGESTED. THE BATTERIES EXITED PATIENT'S SYSTEM AND THE PATIENT DID NOT EXPERIENCE ANY HARM DUE TO THIS INCIDENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 21676611 ↗

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Sources and updates

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