Swing Maxi™ Hands-free 101046709Recalls & reported problems
Medela LLC · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00020451467092), received between Dec 23, 2025 and Apr 15, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Suction Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Suction Problem2
- Accessory Incompatible1
Patient problems
- Inflammation3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 15, 2026Suction Problem
ON (B)(6) 2026, THE CUSTOMER REACHED OUT TO MEDELA LLC VIA INSTAGRAM. SHE ALLEGED THAT HER SWING MAXI BREAST PUMP HAD LOW SUCTION AND THE PUMP WAS SHUTTING OFF AFTER 5 MIN. SHE ADDITIONALLY REPORTED THAT SHE HAD MASTITIS AND WAS PRESCRIBED ANTIBIOTICS BY HER HEALTHCARE PROVIDER.
Patient problems: Inflammation
MAUDE report 24887944 ↗InjuryJan 28, 2026Accessory Incompatible
ON (B)(6) 2026, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS IN EXCRUCIATING PAIN, AND IT FEELS AS IF HER NIPPLE IS BEING PINCHED, SHE BELIEVES SHE HAS THE WRONG BREAST SHIELD SIZE. SHE REPORTED SHE HAS MASTITIS AND BELIEVES IT'S FROM USING HER SWING MAXI BREAST PUMP. HER DOCTOR PRESCRIBED HER ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 24199673 ↗InjuryDec 23, 2025Suction Problem; Suction Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SWING MAXI BREAST PUMP WAS NOT PRODUCING SUCTION AND WASN'T AUTOMATICALLY TURNING OFF. SHE ADDITIONALLY REPORTED THAT SHE HAD MASTITIS WHILE USING THE PUMP AND WAS TREATED WITH ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 23875912 ↗
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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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