Freestyle Hands-free 101044164Recalls & reported problems
Medela AG · Double electric, single user breast pump intended to express & collect breast milk · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medela Freestyle hands-free breast pump is a double electric pump for expressing and collecting breast milk. The 25 reports describe weak or fading suction, battery and shut-off problems and poor fit leading to poor drainage, and all mention breast infection often treated with antibiotics, with no deaths and 25 injuries. No recalls name this device. Reports dropped to 0 in the last 12 months from 9 the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00020451441641), received between May 23, 2023 and Sep 10, 2026 — classified as 26 injuries.
The most frequently reported specific device problem is “Suction Problem” (16 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
Most reported problems
Device problems
- Suction Problem16
- Power Problem9
- Fitting Problem1
- No Display/Image1
Patient problems
- Inflammation26
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Suction Problem
On (b)(6) 2026, The customer contacted Medela LLC that while using the Freestyle Hands-free she was diagnosed with mastitis due to poor or insufficient suction. Additionally, on (b)(6) 2026 she alleged that she was prescribed antibiotics.
Patient problems: Inflammation
MAUDE report 50714764 ↗InjuryAug 26, 2025Fitting Problem; Fitting Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER 27MM BREAST SHIELDS FOR HER FREESTYLE HANDS FREE BREAST PUMP DID NOT FIT HER CUPS. SHE ADDITIONALLY ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 22892856 ↗InjuryAug 8, 2025Suction Problem; Suction Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SUCTION HAD DETERIORATED WITH THEIR FREESTYLE HANDS FREE BREAST PUMP. THE CUSTOMER ALSO ALLEGED THEY DEVELOPED MASTITIS AND RECEIVED MEDICAL ATTENTION IN THE ER.
Patient problems: Inflammation
MAUDE report 22747862 ↗InjuryAug 6, 2025Suction Problem; Suction Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT DUE TO POOR DRAINAGE WHILE USING THE FREESTYLE HANDS-FREE BREAST PUMP SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AND ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 22724959 ↗InjuryJul 17, 2025Power Problem; Power Problem
ON 06/30/2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING BATTERY CHARGING ISSUES WITH HER FREESTYLE HANDS FREE BREAST PUMP. SHE ADDITIONALLY ALLEGED SHE HAD MASTITIS, AND WAS PRESCRIBED ANTIBIOTICS TO TREAT THE INFECTION BY HER DOCTOR.
Patient problems: Inflammation
MAUDE report 22533061 ↗InjuryMay 22, 2025Suction Problem; Suction Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE HANDS FREE BREAST PUMP SUCTION FELT OFF. THE CUSTOMER ALSO ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 22069583 ↗InjuryMay 13, 2025Power Problem; Power Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE BREAST PUMP WAS SHUTTING OFF WHILE USING IT. SHE THEN CONTACTED MEDELA ON (B)(6) 2025 AND REPORTED SHE DEVELOPED MASTITIS WHILE WAITING FOR HER REPLACEMENT PUMP TO ARRIVE AND WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 22011443 ↗InjuryMay 13, 2025Suction Problem; Suction Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE HANDSFREE PUMP WAS HAVING SUCTION ISSUES WHICH LEAD TO HER BEING DIAGNOSED WITH MASTITIS. SHE WAS PRESCRIBED DICLOXACILLIN AND TOLD TO TAKE IBUPROFEN.
Patient problems: Inflammation
MAUDE report 22011025 ↗InjuryMar 31, 2025Suction Problem; Suction Problem
ON (B)(6) 2025 , THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS HAVING ISSUES WITH HER TUBING FOR HER FREESTYLE BREAST PUMP. SHE ADDITIONALLY ALLEGED THAT THE PUMP WAS HAVING POWER ISSUES, AND SHE DEVELOPED MASTITIS AND WAS TREATED WITH MEDICATION.
Patient problems: Inflammation
MAUDE report 21734596 ↗InjuryFeb 18, 2025Suction Problem; Suction Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS HAVING SUCTION ISSUES WITH HER FREESTYLE HANDS FREE BREAST PUMP. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS TREATED FOR IT.
Patient problems: Inflammation
MAUDE report 21404940 ↗InjuryOct 16, 2024Suction Problem; Suction Problem
ON (B)(6)2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER FREESTYLE FLEX BREAST PUMP. SHE ADDITIONALLY REPORTED THAT SHE HAD MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 20460346 ↗InjuryJul 25, 2024Power Problem; Power Problem
ON 7/17/2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE HANDS-FREE BREAST PUMP POWERING OFF ON HER AND SHE WASN'T ABLE TO GET HER MILK OUT. ADDITIONALLY, SHE ALLEGED THAT DUE TO NOT GETTING ALL THE MILK OUT SHE DEVELOPED MASTITIS TWICE FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 19826307 ↗InjuryJul 8, 2024Suction Problem; Suction Problem
ON (B)(6) 2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE COLLECTION CUPS FOR HER FREESTYLE HANDSFREE PUMP WERE BROKEN ON THE BOTTOM. THE CUSTOMER ALSO ALLEGED THE BREAST SHIELD SIZE SHE WAS USING WAS NOT HER SIZE, THEREFORE SHE WAS NOT GETTING APPROPRIATE SUCTION. THE CUSTOMER STATED HER LACTATION CONSULTANT RECOMMENDED THAT SHE PURCHASE BREAST SHIELD INSERTS TO MAKE THE BREAST SHIELDS FIT HER, BUT THE CUSTOMER DID NOT WANT TO USE THE DEVICE ANYMORE. THE CUSTOMER ALSO ALLEGED; THE CUPS HURT HER.
Patient problems: Inflammation
MAUDE report 19687996 ↗InjuryMay 17, 2024Power Problem; Power Problem
ON (B)(6) 2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE HANDS-FREE BREAST PUMP HAD POWER ISSUE. ADDITIONALLY, SHE ALLEGED SHE HAD MASTITIS.
Patient problems: Inflammation
MAUDE report 19339266 ↗InjuryApr 18, 2024Power Problem; Power Problem
ON (B)(6) 24 THE CUSTOMER EMAILED MEDELA LLC THAT HER FREESTYLE HANDSFREE PUMP STOPPED HOLDING A CHARGE. ADDITIONALLY, THE CUSTOMER REPORTED SHE HAD DEVELOPED MASTITIS.
Patient problems: Inflammation
MAUDE report 19132283 ↗InjuryApr 1, 2024Suction Problem; Suction Problem
ON 3/26/24, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE COLLECTION CUP FOR HER FREESTYLE HANDSFREE PUMP WAS NOT CLOSING PROPERLY AND IS LEAKING HUMAN BREAST MILK. THE CUSTOMER ALSO REPORTED THAT SHE HAD DEVELOPED MASTITIS AND WAS PRESCRIBED ANTIBIOTICS BY HER DOCTOR.
Patient problems: Inflammation
MAUDE report 19011137 ↗InjuryMar 12, 2024No Display/Image; No Display/Image
ON 3/8/24, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE HANDSFREE PUMP TOUCH SCREEN WAS UNRESPONSIVE AND WAS HAVING ISSUES WITH THE TUBING STAYING IN PLACE. THE CUSTOMER ALSO ALLEGED, THAT SHE HAD DEVELOPED MASTITIS FROM THE PUMP ALSO HAVING LOW SUCTION AND WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 18885080 ↗InjuryFeb 1, 2024Suction Problem; Suction Problem
ON (B)(6) 2024, THE CUSTOMER REPORTED TO MEDELA GERMANY THAT HER FREESTYLE HANDS FREE BREAST PUMP WAS EXPERIENCING LOW SUCTION. SHE ADDITIONALLY ALLEGED SHE WAS HOSPITALIZED FOR MASTITIS.
Patient problems: Inflammation
MAUDE report 18623822 ↗InjuryNov 9, 2023Suction Problem; Power Problem; Suction Problem; Power Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE HANDS-FREE BREAST PUMP TURNS OFF AND THE PUMP SPEED GOES UP AND DOWN ON ITS OWN. ADDITIONALLY, THE CUSTOMER ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 18100007 ↗InjuryAug 8, 2023Power Problem; Power Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE HANDSFREE PUMP WAS EXPERIENCING POWER ISSUES. THE CUSTOMER ALSO ALLEGED SHE HAD DEVELOPED MASTITIS AND WAS PRESCRIBED BACTRIM FROM HER DOCTOR.
Patient problems: Inflammation
MAUDE report 17480009 ↗InjuryAug 7, 2023Power Problem; Power Problem
ON 7/19/2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE HANDS FREE BREAST PUMP WILL NOT POWER ON. ON 7/19/2023, THE CUSTOMER ALSO EMAILED THAT HER FREESTYLE HANDS FREE WAS FAILING HER. ADDITIONALLY, SHE ALLEGED THAT IT STARTED WITH BEING UNABLE TO USE THE TOUCH SCREEN OCCASIONALLY AND HAVING TO RESET IT BUT TONIGHT THE VACUUM DECREASED ON ITS OWN AND THEN SHUT, OFF DESPITE HAVING TWO BARS OF CHARGE. SHE ALLEGED THAT SHE COULD TURN IT BACK ON TO START A NEW PUMP CYCLE, BUT IT TURNED OFF AGAIN WITHIN 2 MINUTES. SHE ALSO ALLEGED THAT SHE HAS TRIED LEAVING IT PLUGGED INTO THE WALL AND IT IS NOT RESOLVING THE ISSUE. THE CUSTOMER ALSO ALLEGED THAT SHE HAD MASTITIS TWICE.
Patient problems: Inflammation
MAUDE report 17469637 ↗InjuryJul 5, 2023Suction Problem; Suction Problem
ON 06/27/2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HIS WIFE HAS MASTITIS BECAUSE SHE IS UNABLE TO EXPRESS MILK AND HAS LOW SUCTION WITH HER FREESTYLE HANDS FREE BREAST PUMP.
Patient problems: Inflammation
MAUDE report 17258569 ↗InjuryJun 26, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE DEVELOPED MASTITIS DUE TO THE FIT OF THE PARTS ON THE FREESTYLE HANDS-FREE BREAST PUMP AND WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 17198450 ↗InjuryJun 21, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER EMAILED MEDELA LLC STATING HER FREESTYLE HANDSFREE PUMP WAS HAVING AN ISSUE WITH LOW SUCTION. THE CUSTOMER ALSO ALLEGED SHE WAS DIAGNOSED WITH MASTITIS.
Patient problems: Inflammation
MAUDE report 17169386 ↗InjuryJun 7, 2023Power Problem; Power Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE HANDS-FREE BREAST PUMP STOPPED POWERING ON. SHE ALSO ALLEGED SHE DEVELOPED MASTITIS AND WAS TREATED WITH ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 17077679 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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