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Pump In Style® Pro 101047090Recalls & reported problems

Medela LLC · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00020451470900), received between Nov 19, 2025 and Aug 26, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Suction Problem” (4 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 16, 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: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 2 reportsFeb 2026: 0 reportsMar 2026: 2 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 2 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Suction Problem4
  • Power Problem3

Patient problems

  • Inflammation7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 26, 2026Power Problem

    On (b)(6) 2026, the customer alleged to Medela LLC that her Pump In Style Pro was having trouble powering on. Additionally, she alleged that she developed mastitis and was prescribed antibiotics.

    Patient problems: Inflammation

    MAUDE report 50449488 ↗
  • InjuryAug 18, 2026Suction Problem

    On (b)(6) 2026, The customer called Medela LLC stating that while using the Pump In Style Pro she was diagnosed with mastitis due to poor or insufficient suction. Additionally, she alleged that she was prescribed antibiotics.

    Patient problems: Inflammation

    MAUDE report 50300678 ↗
  • InjuryMar 25, 2026Power Problem

    ON (B)(6) 2026, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING HER PUMP IN STYLE PRO THE MOTOR MALFUNCTIONED CAUSING THE PUMP TO LOSE SUCTION. ADDITIONALLY, THE CUSTOMER ALLEGED THAT SHE DEVELOPED MASTITIS REQUIRING ANTIBIOTICS.

    Patient problems: Inflammation

    MAUDE report 24686060 ↗
  • InjuryMar 18, 2026Suction Problem

    ON 3/2/26, THE CUSTOMER EMAILED MEDELA LLC THAT WHILE USING THE PUMP IN STYLE PRO SHE WAS DIAGNOSED WITH MASTITIS DUE TO POOR OR INSUFFICIENT EMPTYING OF HER BREASTS. ADDITIONALLY, SHE ALLEGED THAT SHE WAS ADMITTED TO THE HOSPITAL AND RECEIVED IV ANTIBIOTICS.

    Patient problems: Inflammation

    MAUDE report 24629178 ↗
  • InjuryJan 21, 2026Suction Problem

    ON 01/07/2026, THE CUSTOMER ALLEGED TO MEDELA LLC THAT FROM THE BEGINNING SHE EXPERIENCED LOW SUCTION WITH HER PUMP IN STYLE PRO BREAST PUMP. SHE ADDITIONALLY ALLEGED THAT SHE DEVELOPED MASTITIS, WAS ADMITTED TO THE HOSPITAL AND PRESCRIBED ANTIBIOTICS.

    Patient problems: Inflammation

    MAUDE report 24129030 ↗
  • InjuryJan 14, 2026Suction Problem

    ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE PRO WAS MAKING A THUMPING NOISE, AND THE SUCTION WAS NOT CONSISTENT. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED SEVERAL EPISODES OF MASTITIS AND WAS PRESCRIBED ANTIBIOTICS.

    Patient problems: Inflammation

    MAUDE report 24065753 ↗
  • InjuryNov 19, 2025Power Problem; Power Problem

    ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE PRO BREAST PUMP CORD HAS TO BE HELD A CERTAIN WAY TO TURN THE PUMP ON DUE TO THE DC JACK BEING TILTED. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND WENT TO URGENT CARE AND WAS PRESCRIBED AN ANTIBIOTIC.

    Patient problems: Inflammation

    MAUDE report 23592680 ↗

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Sources and updates

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