safePICO70Recalls & reported problems across all models

We found 7 models of safePICO70 by Radiometer Medical ApS in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Oct 13, 2017 and Jan 14, 2026 — classified as 8 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported safePICO70 problems

safePICO70 models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• safePICO70 956-616

  Tubes, vials, systems, serum separators, blood collection
  20 reports
• safePICO70 956-613

  Tubes, vials, systems, serum separators, blood collection
  10 reports
• safePICO70 956-610

  Tubes, vials, systems, serum separators, blood collection
  9 reports
• safePICO70 956-615

  Tubes, vials, systems, serum separators, blood collection
  4 reports
• safePICO70 956-614

  Tubes, vials, systems, serum separators, blood collection
  2 reports
• safePICO70 956-608

  Tubes, vials, systems, serum separators, blood collection
  1 report
• safePICO70 956-612

  Tubes, vials, systems, serum separators, blood collection
  1 report

Recent safePICO70 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Fluid/Blood Leak; Insufficient Device Problem Information

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2026 WHILE USING THE SAFEPICO SAMPLER (LOT NUMBER: EE52), THE USER WAS CONTAMINATED WITH BLOOD FROM THE SAMPLER. THERE WAS A CRACK IN THE LOWER PART OF THE SAMPLER.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24066111 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  RADIOMETER COMPLAINT REFERENCE: (B)(4). THE USER USED A SAFEPICO70 (LOT NUMBER: RC52) TO DRAW SAMPLE FROM A PATIENT. BLOOD SPURTED EVERYWHERE FROM THE SYRINGE AND THE USER NOTICED THE SYRINGE WAS CRACKED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23875842 ↗
• MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO THE COMPLAINT, THE USER USED A SAFEPICO70 (LOT NUMBER: RE54) TO DRAW SAMPLE FROM A PATIENT. THE BLOOD DRAWN WAS SUCCESSFUL AND THE AIR WAS EXPELLED NORMALLY. THE SAMPLE WAS PLACED ON THE COUNTER AND WHEN THE USER WENT TO GRAB THE SAMPLE AGAIN, THE CAP FLEW OFF THE SYRINGE SPRAYING BLOOD UP THE WALL AND ON HER CHEST AND ARM WITH FORCE. THE USER DID NOT GET THE BLOOD IN HER EYES OR MOUTH.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23847621 ↗
• MalfunctionNov 19, 2025Corroded; Corroded

  RADIOMETER REFERENCE NUMBER: (B)(4). ACCORDING TO COMPLAINT, THE CUSTOMER REPORTED MULTIPLE SAFEPICO70 SAMPLERS (TOTAL OF 4 SAMPLERS FOR LOT NUMBER DU50 AND A TOTAL OF 9 SAMPLERS FOR LOT NUMBER DX51) EXHIBITING SIGNS OF CORROSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593262 ↗
• 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 ↗
• MalfunctionJul 14, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  RADIOMETER REFERENCE (B)(4). ACCORDING TO THE COMPLAINT, ON (B)(6) 2025, AT 8:38, A PATIENT VISITED THE HOSPITAL FOR TREATMENT. FOLLOWING THE DOCTOR'S ORDER FOR ARTERIAL BLOOD COLLECTION, THE NURSE DISCOVERED AFTER COLLECTING THE ARTERIAL BLOOD THAT THE SAFEPICO70 (LOT NO. CY50) LACKED THE BLUE PLASTIC CUBE USED FOR NEEDLE PROTECTION. THE NURSE IMMEDIATELY REPLACED IT WITH A SAFEPICO70 THAT INCLUDED A BLUE PLASTIC CUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492845 ↗
• MalfunctionMay 2, 2025Labelling, Instructions for Use or Training Problem; Manufacturing, Packaging or Shipping Problem; Labelling, Instructions for Use or Training Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE COMPLAINT, A WAREHOUSE OPERATOR FOUND THAT A SAFEPICO RETAIL BOX WAS MISSING THE INSERTS, QUALIFIED CERTIFICATE AND 2 SAMPLERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949609 ↗
• MalfunctionMar 31, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE COMPLAINT, A WAREHOUSE OPERATOR FOUND THAT A SAFEPICO RETAIL BOX WAS MISSING THE INSERTS AND QUALIFIED CERTIFICATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729331 ↗
• 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 ↗

Other Radiometer Medical ApS products

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