Spectra Spectra S1 plusRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08809108011091), received between Nov 25, 2022 and Apr 21, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Device Contamination with Body Fluid

  TARGET AT (B)(6) WILLINGLY SOLD A PREVIOUSLY USED AND RETURNED BREAST PUMP (A 5-YEAR-OLD UNIT BASED ON THE SERIAL NUMBER) TO ME. THE CORPORATION DOES NOT ACCEPT RETURN OF ANY MEDICAL DEVICE, REGARDLESS OF THE CONDITION. I AM STUCK WITH A USED PUMP AFTER PAYING FULL PRICE, AND HAVE NO WAY OF GETTING A REPLACEMENT OR A REFUND.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21874146 ↗
• MalfunctionDec 5, 2022Defective Component

  THE BREAST PUMP STOPPED TURNING ON DURING NORMAL USE. MY WIFE USES THIS BREAST PUMP TO EXPRESS MILK USED TO FEED OUR INFANT CHILD. THE BREAST PUMP WAS ONLY 3 MONTHS OLD AND UNDER WARRANTY. WE CONTACTED THE MANUFACTURER (SPECTRA) ABOUT THE DEFECTIVE UNIT (SPECTRA S1 PLUS). SPECTRA HAS STILL NOT PROVIDED US WITH A REPLACEMENT PUMP. THIS IS CAUSING MY WIFE SEVERE EMOTIONAL AND PHYSICAL PAIN AS SHE STRUGGLES TO FEED OUR CHILD. ADDITIONALLY, MY WIFE HAS AN OVERSUPPLY OF BREAST MILK AND THE UNEXPECTED FIELD FAILURE OF THIS MEDICAL DEVICE PUTS HER AT RISK OF MASTITIS. SPECTRA ALSO DOES NOT FOLLOW THEIR POSTED HOURS PER THE WEBSITE AND IS DIFFICULT TO CONTACT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Pain; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 15925374 ↗
• MalfunctionNov 25, 2022Fire; Fire

  IT WAS REPORTED THAT PRODUCT HAS A FIRE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RESULT OF REVIEWING THE CAUSE OF THE PRODUCT FIRE IS PRESUMED THAT THE BATTERY WAS FIRED.

  Patient problems: Insufficient Information

  MAUDE report 15864034 ↗