safePICO Aspirator 956-622Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05700699566225), received between Aug 17, 2017 and Dec 23, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  RADIOMETER COMPLAINT REFERENCE: (B)(4). THE USER TOOK THE ARTERIAL BLOOD SAMPLE PREVIOUSLY COLLECTED WITH A SAFEPICO ASPIRATOR (LOT NUMBER: RE11) BY HER COLLEAGUE. WHEN THE USER INSERTED THE SAMPLER INTO THE MACHINE, IT STARTED SPRAYING EVERYWHERE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23875535 ↗
• MalfunctionAug 16, 2023Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE COMPLAINT, ON B)(6) 2023, WHEN THE OPERATOR TRIED TO VENT AIR FROM BLOOD SAMPLE IN THE SAFEPICO ASPIRATOR USING VTC, HE FELT THE PLUNGER WAS STIFF, BUT PUSHED THE PLUNGER ANYWAY. THEN BLOOD SPOUTED FROM THE TIP OF THE VTC, AND THE OPERATOR WAS EXPOSED TO THE BLOOD ON HIS FACE. THE OPERATOR UNDERWENT A BLOOD TEST, AND FORTUNATELY NO INFECTION HAS BEEN CONFIRMED AT THIS TIME. IT WAS CONFIRMED THAT THE OPERATOR WAS EXPOSED TO THE BLOOD ON ONLY HIS SKIN AND CLOTHES, NOT ON MUCOUS MEMBRANES SUCH AS EYES AND MOUTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555913 ↗
• MalfunctionSep 30, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE COMPLAINT, ON (B)(6) 2022, WHEN THE OPERATOR TRIED TO VENTILATE AIR FROM THE SAMPLER, THE TIP CAP (VTC) GOT OUT OF THE SAMPLER, AND THE BLOOD INSIDE THE SAMPLER SPURTED UP TO THE CEILING. ACCORDING TO A RADIOMETER SERVICE ENGINEER WHO VISITED THE HOSPITAL, THE OPERATOR WAS TRAINED, AND THIS EVENT OCCURRED WHEN THE OPERATOR TRIED TO VENTILATE AIR AS USUAL (WITH THE SAME FORCE AS USUAL). NO ONE WAS EXPOSED TO THE BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518596 ↗
• MalfunctionMay 23, 2022Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem

  ACCORDING TO THE COMPLAINT WHEN THE CUSTOMER WAS TO ASPIRATE A BLOOD SAMPLE FROM A CATHETER, THEY EXPERIENCED THAT THERE WAS HARDLY ANY STOPPER FOR THE PLUNGER OF THE ASPIRATOR, WHICH CAUSED THE USER TO PULL OUT THE PLUNGER OF THE SAMPLER WHICH SPLASHED THEM WITH BLOOD ALL OVER. NO REPORTS OF DEATH OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14468831 ↗
• MalfunctionAug 17, 2017High Test Results; High Test Results

  ACCORDING TO THE CUSTOMER, FALSE HIGH NA RESULTS WERE OBTAINED FROM THE ABL800 ANALYZER WHEN USING THE SAFEPICO ASPIRATOR, LOT YM-01. WHEN USING A DIFFERENT LOT OF THE SAMPLER, THE PROBLEM DIDN'T APPEAR AT ALL. NO PATIENTS WERE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6800066 ↗