safePICO70 956-613Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05700699566133), received between Oct 14, 2022 and Nov 18, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Corroded” (4 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.

• MalfunctionNov 18, 2025Corroded; Corroded

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED THAT ON 04NOV2025, WHEN THE NURSE OPENED THE PACKAGING OF A SAFEPICO70 (LOT NUMBER CJ05) TO COLLECT AN ARTERIAL BLOOD SAMPLE, SHE FOUND THAT THE NEEDLE WAS RUSTY. SHE IMMEDIATELY REPORTED IT TO THE HEAD NURSE AND DID NOT USE THE SAMPLER. A NEW SAFEPICO WAS USED TO COLLECT THE SAMPLE FROM THE PATIENT. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581489 ↗
• InjuryAug 6, 2025Component Missing; Component Missing

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2025 A CUSTOMER WAS OPENING THE PACKAGING OF THE SAFEPICO SAMPLER (LOT NUMBER: DF11) AND WAS PRICKED BY THE NEEDLE, AS IT WAS MISSING THE NEEDLE PROTECTIVE COVER. THE SAMPLER WAS AN UNUSED SAMPLER WHEN THE INCIDENT OCCURRED. THIS ISSUE IS COVERED BY RISK ID 74 WITH A SEVERITY OF 4 (PERMANENT/SERIOUS) ACCORDING TO THE (B)(4) - PRODUCT RISK ANALYSIS FOR SAMPLERS, (REV. 21). NO REPORTS OF DEATH.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22724979 ↗
• MalfunctionFeb 21, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  ACCORDING TO THE COMPLAINT, AFTER SUCCESSFULLY COLLECTING A BLOOD SAMPLE USING THE SAFEPICO70 ARTERIAL BLOOD SAMPLER, THE USER PREPARED TO REMOVE THE METAL NEEDLE AND THEN PLACE THE VENT CAP. DURING THE REMOVAL OF THE NEEDLE, THE LUER CONNECTOR BROKE, CAUSING BLOOD TO SPURT OUT. NEITHER THE OPERATOR NOR THE PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431454 ↗
• MalfunctionNov 7, 2024Corroded; Corroded

  ACCORDING TO THE COMPLAINT, THE USER WAS PREPARING TO PERFORM AN ARTERIAL BLOOD SAMPLING ON THE PATIENT USING SAFEPICO70 SAMPLER (LOT NUMBER: BV06). UPON OPENING THE OUTER PACKAGING, AND INSPECTING THE SAMPLER, THE USER NOTICED THE NEEDLE HAD CORRODED WITH FOREIGN OBJECTS INSIDE THE NEEDLE HUB. THE USER IMMEDIATELY REPLACED IT WITH A NEW SAMPLER AND WAS NOT USED FOR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629824 ↗
• MalfunctionAug 22, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ON 2024-08-01, DURING BLOOD GAS ANALYSIS USING THE SAFEPICO ARTERIAL BLOOD SAMPLER (LOT NO BI01), IT WAS FOUND THAT THE NEEDLE CUBE WAS MISSING, HENCE THE USER HAD NO NEEDLE STICK PROTECTION. IMMEDIATELY, THE DISPOSABLE ARTERIAL BLOOD SAMPLE COLLECTOR WAS REPLACED, AND THE INCIDENT DID NOT CAUSE ANY ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027962 ↗
• MalfunctionAug 20, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ON (B)(6) 2024, A NEWLY ADMITTED PATIENT UNDERWENT ARTERIAL BLOOD GAS ANALYSIS IN ACCORDANCE WITH MEDICAL ORDERS. HOWEVER, UPON OPENING THE PACKAGING OF THE SAFEPICO ARTERIAL BLOOD SAMPLER (LOT NO NY02), IT WAS FOUND THAT THE NEEDLE CUBE WAS MISSING, HENCE THE USER HAD NO NEEDLE STICK PROTECTION. IMMEDIATELY, THE DISPOSABLE ARTERIAL BLOOD SAMPLE COLLECTOR WAS REPLACED, AND THE INCIDENT DID NOT CAUSE ANY ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001566 ↗
• MalfunctionJun 27, 2024Corroded; Corroded

  ACCORDING TO THE COMPLAINT, ON (B)(6) 2024, AS THE NURSE WAS PREPARING TO PERFORM A BLOOD GAS ANALYSIS TEST ON A PATIENT, SHE CHECKED THE SAFEPICO (LOT NUMBER: NA01) AND CONFIRMED THAT IT WAS AIRTIGHT AND WITHIN ITS EXPIRATION DATE. HOWEVER, UPON OPENING THE PACKAGE AND RECHECKING THE DEVICE, THE NURSE FOUND THAT THE NEEDLE OF THE SAFEPICO WAS RUSTY. THE RUSTY NEEDLE WAS NOT USED FOR TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622599 ↗
• MalfunctionMar 25, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE COMPLAINT ON (B)(6) 2024, THE NURSE OPENED THE BLISTER, AND FOUND THERE WAS A LINT IN THE SYRINGE (SAFEPICO). THE USER REPLACED WITH A NEW SAMPLER. THERE WAS NO HARM REPORTED. FROM THE DATA PROVIDED IT IS UNKNOWN IF THE LINT WAS COMING THROUGH THE BLISTER OR IF THE LINT WAS COMPLETELY INSIDE THE BLISTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967055 ↗
• MalfunctionJan 3, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE COMPLAINT, ON 2023-11-10 THE USER OPENED THE BLISTER OF THE SAFEPICO (LOT NUMBER: NL50) AND FOUND A BLACK FOREIGN MATTER IN THE SYRINGE. THE USER REPLACED THE SAFEPICO, AND THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434409 ↗
• MalfunctionOct 14, 2022Corroded; Material Integrity Problem; Corroded; Material Integrity Problem

  ACCORDING TO THE COMPLAINT THE CUSTOMER DISCOVERED A RUSTY NEEDLE ON A SAFEPICO SAMPLER. THE CUSTOMER RETURNED THE SAMPLER BOX (100 PIECES) BACK TO RADIOMETER ON (B)(6) 2022. IT WAS CONFIRMED THAT THE RUSTY NEEDLE WAS DISCARDED AND NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15605183 ↗