Pump In Style® Hands-free 101045436Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00020451454368), received between Apr 12, 2024 and Jul 30, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Suction Problem” (7 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Suction Problem

  On (b)(6) 2026, the customer alleged to Medela LLC that she had no suction with her Pump In Style HF breast pump. The customer also alleged that she developed mastitis and got medication.

  Patient problems: Inflammation

  MAUDE report 50082194 ↗
• InjuryDec 22, 2025Suction Problem; Suction Problem

  ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING HER PUMP IN STYLE HANDS-FREE BREAST PUMP, HER PUMP STOPPED SUCTIONING. THE CUSTOMER ALSO ALLEGED SHE DEVELOPED AN ABSCESSED INFECTION.

  Patient problems: Abscess

  MAUDE report 23862625 ↗
• InjuryDec 17, 2025Power Problem; Power Problem

  ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THEIR PUMP IN STYLE HANDS FREE BREAST PUMP WAS HURTING THEIR NIPPLES, AND THE PUMP WAS HAVING POWER ISSUES. THE CUSTOMER ADDITIONAL ALLEGED THEY DEVELOPED MASTITIS DUE TO THE PUMP NOT WORKING PROPERLY.

  Patient problems: Inflammation

  MAUDE report 23826259 ↗
• InjuryAug 21, 2025Suction Problem; Suction Problem

  ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE HAD A CRACK IN HER TUBING TO HER PUMP IN STYLE HANDS FREE BREAST PUMP. SHE ADDITIONALLY REPORTED THAT SHE CURRENTLY HAS MASTITIS AND IS BEING TREATED WITH ANTIBIOTICS.

  Patient problems: Inflammation

  MAUDE report 22862391 ↗
• InjuryJun 12, 2025Suction Problem; Suction Problem

  ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SUCTION WAS WEAK ON HER PUMP IN STYLE BREAST PUMP AND SHE WAS ON AN ANTIBIOTIC.

  Patient problems: Inflammation

  MAUDE report 22192234 ↗
• InjuryMay 28, 2025Suction Problem; Suction Problem

  ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE HANDSFREE PUMP WAS CREATING SUCTION ON ONLY ONE SIDE. CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER INCLUDING VERIFYING NO MILK BACK UP HAD OCCURRED, NO DAMAGE TO THE POWER CORD AND DC JACK. THE CUSTOMER STATED SHE HAD BEEN USING AN ELECTRIC STERILIZER WHICH WE DO NOT RECOMMEND SINCE THAT CAN DAMAGE/WARP OUR PARTS. CUSTOMER SERVICE ASKED THE CUSTOMER FOR A PROOF OF PURCHASE TO REPLACE PARTS AND SHE SAID SHE WILL CALL BACK WITH THAT. ON (B)(6) 2024, THE CUSTOMER CALLED BACK INTO MEDELA WITH HER PROOF OF PURCHASE TO GET HER REPLACEMENT PUMP PARTS. THE CUSTOMER STATED SHE HAD DEVELOPED MASTITIS DUE TO NOT BEING ABLE TO PUMP AND RECEIVED ANTIBIOTICS FROM HER MEDICAL PROVIDER.

  Patient problems: Inflammation

  MAUDE report 22094634 ↗
• InjuryOct 7, 2024Fitting Problem; Fitting Problem

  ON (B)(6) 2024, THE CUSTOMER EMAILED MEDELA LLC AND ALLEGED SHE HAD MASTITIS AND NEEDED SMALLER BREAST SHIELDS TO USE WITH HER PUMP IN STYLE BREAST PUMP.

  Patient problems: Inflammation

  MAUDE report 20383312 ↗
• InjurySep 10, 2024Use of Device Problem; Use of Device Problem

  ON 08/31/2024, THE CUSTOMER EMAILED MEDELA LLC AND ALLEGED THE MOTOR ON HER PUMP IN STYLE BREAST PUMP WAS NO LONGER WORKING. SHE ADDITIONALLY ALLEGED SHE HAD MASTITIS.

  Patient problems: Inflammation

  MAUDE report 20178974 ↗
• InjuryJun 17, 2024Suction Problem; Suction Problem

  ON 05/31/2024, THE CUSTOMER EMAILED MEDELA LLC THAT HER PUMP IN STYLE MAXFLOW HANDSFREE PUMP WAS NOT EXPRESSING HER BREAST MILK AS EFFICIENTLY AS HER OTHER PUMP. THE CUSTOMER STATED SHE ORDERED A WHOLE NEW SET OF PUMPING PARTS AND MADE SURE THEY WERE ATTACHED PROPERLY BUT WAS STILL HAVING LOW BREAST MILK EXPRESSION. THE CUSTOMER ALSO ALLEGED SHE DEVELOPED MASTITIS.

  Patient problems: Inflammation

  MAUDE report 19546889 ↗
• InjuryApr 12, 2024Suction Problem; Suction Problem

  ON (B)(6) 2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE HANDS-FREE BREAST PUMP HAS LOW SUCTION. ON (B)(6) 2024, THE CUSTOMER CALLED BACK AFTER GETTING THE REPLACEMENT PARTS THAT WERE SENT TO HER AND ALLEGED THAT THEY DIDN'T HELP WITH THE PUMPS LOW SUCTION ISSUE. ADDITIONALLY, THE CUSTOMER ALLEGED THAT SHE DEVELOPED MASTITIS AND IS TAKING MEDICATION.

  Patient problems: Inflammation

  MAUDE report 19094976 ↗