SECURERecalls & reported problems across all models

We found 16 models of SECURE by Metrix Company, The in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Sep 8, 2020 and May 30, 2025 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (21 reports).

8 FDA recall records name at least one of these models by its device identifier, 7 still open.

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

SECURE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 9, 2024Open, Classified

   A limited number of IV bags have been found to leak during filling.

   Z-0341-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 9, 2024Open, Classified

   A limited number of IV bags have been found to leak during filling.

   Z-0340-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Oct 9, 2024Open, Classified

   A limited number of IV bags have been found to leak during filling.

   Z-0339-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Oct 9, 2024Open, Classified

   A limited number of IV bags have been found to leak during filling.

   Z-0338-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Oct 9, 2024Open, Classified

   A limited number of IV bags have been found to leak during filling.

   Z-0337-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Oct 9, 2024Open, Classified

   A limited number of IV bags have been found to leak during filling.

   Z-0336-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. Oct 9, 2024Open, Classified

   A limited number of IV bags have been found to leak during filling.

   Z-0335-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Sep 13, 2017Terminated

   The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.

   Z-3240-2017 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported SECURE problems

SECURE models

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

• SECURE® 66040

  Container, I.V.
  1 recall8 reports
• SECURE® 66045

  Container, I.V.
  1 recall7 reports
• SECURE® 66043

  Container, I.V.
  1 recall3 reports
• SECURE® 58719

  Container, I.V.
  1 recall2 reports
• SECURE® 66041

  Container, I.V.
  1 recall2 reports
• SECURE® 66050

  Container, I.V.
  1 recall1 report
• SECURE® 66042

  Container, I.V.
  1 recall0 reports
• SECURE® 66055

  Container, I.V.
  1 recall0 reports
• SECURE® 66616

  Container, I.V.
  6 reports
• SECURE® 66631

  Container, I.V.
  6 reports
• SECURE® 66120

  Container, I.V.
  2 reports
• SECURE® 66215

  Container, I.V.
  2 reports
• SECURE® 66210

  Container, I.V.
  1 report
• SECURE® 66225

  Container, I.V.
  1 report
• SECURE® 66405

  Container, I.V.
  1 report
• SECURE® 66653

  Container, I.V.
  1 report

Recent SECURE adverse event reports

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

• MalfunctionMay 30, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A CLEAR PLASTIC PARTICULATE WAS OBSERVED BY A HEALTH PROFESSIONAL IN A SECURE 100 ML EMPTY EVA CONTAINER USED TO COMPOUND AND INFUSE A 7-DAY DOSE OF BLINATUMOMAB. THE ISSUE WAS DISCOVERED BY THE NURSE UPON DISCONNECTING THE COMPLETED INFUSION FROM THE PATIENT. THE PARTICLE APPEARED VISUALLY SIMILAR IN COLOR AND TEXTURE TO THE BAG MATERIAL. LOCAL INVESTIGATION RULED OUT COMPOUNDING TOOLS AND TUBING AS THE SOURCE DUE TO THE PARTICLE'S SIZE AND COLOR. NO PATIENT HARM WAS REPORTED. PHOTOGRAPHS OF THE ISSUE WERE PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION TO THE MANUFACTURER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115755 ↗
• MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER INITIALLY STATED, "OUR COMPOUNDING PHARMACIST LET US KNOW THAT THE 500ML EVA SECURE BAGS (REF 66050) ARE CONSISTENTLY LEAKING. THESE ONES WERE NOT PART OF THE RECALL FROM OCTOBER (THEY HAVE A "10" BETWEEN THE TWO PORTS)". UPON REQUEST FOR ADDITIONAL INFORMATION, THE CUSTOMER FURTHER REPORTED, "THE BAG WAS LEAKING FAIRLY VIGOROUSLY FROM THE BOTTOM OF THE BAG, ON THE OUTSIDE OF THE PORTS (SO, NOT IN BETWEEN THE PORTS). SHE THINKS, BUT IS NOT CERTAIN, THAT IT WAS THE SIDE OF THE BAG WITH THE ADDITION PORT. SHE WAS SPECIFIC THAT IT WAS A NUMBER 8 BAG." THIS LOT NUMBER (66050-A8460) WAS INVOLVED IN THE RECALL CORRECTION OF 2 PORT BAGS MANUFACTURED FROM 12/8/2023 TO 9/26/2024. PER RECALL PROCEEDINGS, THE FINISHED PRODUCT WAS SORTED AND REPACKAGED TO REMOVE CAVITY #6 FROM THE LOT. THE PRODUCT LEAK WAS IDENTIFIED BY THE FILLING PHARMACY, THUS NO PATIENT CONTACT OR ADVERSE EVENT WAS REPORTED. NO SAMPLES OR IMAGES OF THE LEAKING PRODUCT WERE AVAILABLE TO REVIEW. 43 UNUSED SAMPLES WERE RETURNED FROM LOT 66050-A8460 FOR METRIX INVESTIGATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112098 ↗
• MalfunctionOct 3, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  THE CUSTOMER STATED "IT APPEARS THAT THE BAG ITSELF ISN'T SEALED TO THE PORT IN SOME CASES. ONE OTHER INTERESTING THING THAT WE HAVE NOTICED - ALL THE BAGS THAT ARE LEAKING HAVE A SMALL NUMBER 6 IMPRINTED ON THE BAG ITSELF". 15 SAMPLES WERE IDENTIFIED FOR LEAKING BY THE PHARMACY DURING THE COMPOUNDING PROCESS. THERE WAS NO PATIENT INVOLVEMENT FOR THIS EVENT. SAMPLES FROM WITHIN THE LOT WERE RETURNED FOR INVESTIGATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360443 ↗
• MalfunctionApr 26, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT ONE SAMPLE OF PRODUCT WAS IDENTIFIED WITH "A PORT THAT APPEARS TO BE CONTAMINATED OR DAMAGED". THE CUSTOMER REPORTED THE CONTAMINATION APPEARED TO BE STREAKS DOWN THE SIDE OF THE PORT. THIS WAS NOTED BY THE PHARMACY DURING COMPOUNDING. THE SAMPLE WAS RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192257 ↗
• MalfunctionApr 12, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED A LEAK IDENTIFIED DURING PATIENT INFUSION OF A 1000 ML EVA GRAVITY BAG FROM AN APPARENT "SLICE" IN THE PRODUCT LOCATED ON THE BOTTOM OF THE SAMPLE. AS IT WAS IDENTIFIED DURING PATIENT INFUSION, A PARTIAL LOSS OF CONTAINER CONTENTS WAS REPORTED. NO ADVERSE EVENT WAS REPORTED. THE CUSTOMER INITIATED MEDWATCH REPORT MW5152016 FOR THIS EVENT. THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095678 ↗
• MalfunctionApr 2, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CUSTOMER REPORTED PLASTIC FLOATERS IDENTIFIED IN PRODUCT AFTER COMPOUNDING FOR FOUR SAMPLES. THE PARTICULATE CONTAMINATION WAS IDENTIFIED AFTER COMPOUNDING BY THE PHARMACY, THUS THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT. SAMPLES WERE NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028901 ↗
• MalfunctionFeb 23, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A CUSTOMER REPORTED "PART OF THE BAG FLOATING INSIDE THE BAG" POST-COMPOUNDING, AFTER INJECTION OF THE BAG, OF ONE SAMPLE. THE PRODUCT WAS FILLED BY THE PHARMACY AND WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. IMAGES OF THE PRODUCT WERE PROVIDED AND NO PARTICULATE COULD BE VISUALLY IDENTIFIED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773135 ↗
• MalfunctionSep 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A LEAK WAS IDENTIFIED ON ONE SAMPLE OF PRODUCT 66120-A7926 WHILE POOLING MEDICATION AT A PATIENT'S HOME. THE CUSTOMER INDICATED THAT THE LEAK WAS IDENTIFIED BY A HEALTH PROFESSIONAL, THERE WAS NO PATIENT INVOLVEMENT, AND NO RELATED DEATH OR SERIOUS INJURY CAUSED BY THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813876 ↗
• MalfunctionSep 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PARTICULATE WAS IDENTIFIED WITHIN TWO PRODUCT SAMPLES OF PRODUCT 66040 BY THE PHARMACY DURING INSPECTION AFTER FILLING THE BAGS. THE CUSTOMER REPORTED THE BAGS WERE DISCARDED BY THE PHARMACY AND ARE NOT AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703565 ↗
• MalfunctionSep 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PHARMACY TECHNICIANS IDENTIFIED STOCK DILUTIONS PREPARED IN 100 ML SECURE EMPTY BAGS WITH VISIBLE PARTICULATE. THE REPORT INDICATED THE PARTICULATE MATTER IDENTIFIED RESEMBLED A CIRCULAR PLASTIC "FLOATING" PARTICLE "IN THE BAG SOLUTION PRIOR TO FILLING". TWO SAMPLES WERE RETURNED IN A FILLED STATE, BOTH SAMPLES HAD A NON-VENTED DISPENSING PIN INSERTED INTO THE TWIST OFF ADMINISTRATION PORT. ONE PLASTIC CIRCULAR PARTICULATE WAS IDENTIFIED IN BOTH OF THE BAGS RETURNED FOR EVALUATION. BOTH CIRCULAR PARTICULATES MEASURED APPROXIMATELY 3/16" IN DIAMETER AND WERE SIMILAR IN APPEARANCE. AS THE PARTICULATE WAS IDENTIFIED IN THE PHARMACY, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17701798 ↗
• MalfunctionJun 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  SMALL TEAR AT SEPARATOR BAR INSEAM THAT RESULTED IN A LEAK. IT WAS INDICATED BY PERSONNEL THERE WAS NO INDICATOR OF LEAK AT TIME OF FILLING OR SEVERAL BAG INSPECTIONS. UPON REMOVAL OF SEPARATOR BAR, TEAR WAS APPARENT AND BAG LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17147820 ↗
• MalfunctionMar 28, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FLOATERS WERE FOUND POST-COMPOUNDING, AFTER INJECTION OF THE BAGS, IN 10 UNITS. THE CUSTOMER FURTHER REPORTED "WE TYPICALLY PRODUCE BUPIVACAINE AND ROPIVACAINE DILUTIONS IN THOSE BAGS, AS WELL AS NARCOTIC COMBINATIONS WITH THEM (FENTANYL/BUPIVACAINE OR FENTANYL/ROPIVACAINE COMBINATIONS, AS WELL AS THE SAME WITH HYDROMORPHONE COMBINATIONS). WE ALSO OCCASIONALLY MAKE MIDAZOLAM DILUTIONS IN THOSE BAGS AS WELL. WE USE A PERISTALTIC PUMP WITH A 16G BD NEEDLE TO INJECT THE DILUENT AND DRUG INTO THE BAGS. THE 16G NEEDLE IS USED FOR A MAXIMUM OF 5 PUNCTURES AND THE SECURE BAG IS BEING PUNCTURED ONLY 2 TIMES. WE USE THE SAME COMPOUNDING METHOD FOR THE ALTERNATIVE VENDOR'S BAGS AND WE DO NOT SEE THIS ISSUE." THE CUSTOMER ALSO STATED "THE 'FLOATERS' WERE OFTEN LITTLE PIECES OF PLASTIC OF VARYING SHAPES AND SIZES ("CIRCULAR", SPIRAL, OTHER SHAPES WHICH COULD HAVE MORE JAGGED EDGES). THEY WERE USUALLY TOO SMALL TO SEE OUTSIDE OF A VISUAL INSPECTION BOX, AND WERE THE SAME COLOUR AS THE EVA BAGS THEMSELVES." AS THE FLOATERS WERE NOTED AT THE FILLING PHARMACY, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628219 ↗
• MalfunctionMar 28, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FLOATERS WERE FOUND POST-COMPOUNDING, AFTER INJECTION OF THE BAGS, IN 13 UNITS. THE CUSTOMER FURTHER REPORTED "WE TYPICALLY PRODUCE BUPIVACAINE AND ROPIVACAINE DILUTIONS IN THOSE BAGS, AS WELL AS NARCOTIC COMBINATIONS WITH THEM (FENTANYL/BUPIVACAINE OR FENTANYL/ROPIVACAINE COMBINATIONS, AS WELL AS THE SAME WITH HYDROMORPHONE COMBINATIONS). WE ALSO OCCASIONALLY MAKE MIDAZOLAM DILUTIONS IN THOSE BAGS AS WELL. WE USE A PERISTALTIC PUMP WITH A 16G BD NEEDLE TO INJECT THE DILUENT AND DRUG INTO THE BAGS. THE 16G NEEDLE IS USED FOR A MAXIMUM OF 5 PUNCTURES AND THE SECURE BAG IS BEING PUNCTURED ONLY 2 TIMES. WE USE THE SAME COMPOUNDING METHOD FOR THE ALTERNATIVE VENDOR'S BAGS AND WE DO NOT SEE THIS ISSUE." THE CUSTOMER ALSO STATED "THE 'FLOATERS' WERE OFTEN LITTLE PIECES OF PLASTIC OF VARYING SHAPES AND SIZES ("CIRCULAR", SPIRAL, OTHER SHAPES WHICH COULD HAVE MORE JAGGED EDGES). THEY WERE USUALLY TOO SMALL TO SEE OUTSIDE OF A VISUAL INSPECTION BOX, AND WERE THE SAME COLOUR AS THE EVA BAGS THEMSELVES." AS THE FLOATERS WERE NOTED AT THE FILLING PHARMACY, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627369 ↗
• MalfunctionMar 15, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK IN THE MIDDLE LINE OF A 1500 ML EVA DUAL CHAMBER BAG. THIS WAS NOTED BY THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545932 ↗
• MalfunctionMar 8, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FLOATERS WERE FOUND POST-COMPOUNDING, AFTER INJECTION OF THE BAGS. THE CUSTOMER FURTHER REPORTED "WE TYPICALLY PRODUCE BUPIVACAINE AND ROPIVACAINE DILUTIONS IN THOSE BAGS, AS WELL AS NARCOTIC COMBINATIONS WITH THEM (FENTANYL/BUPIVACAINE OR FENTANYL/ROPIVACAINE COMBINATIONS, AS WELL AS THE SAME WITH HYDROMORPHONE COMBINATIONS). WE ALSO OCCASIONALLY MAKE MIDAZOLAM DILUTIONS IN THOSE BAGS AS WELL. WE USE A PERISTALTIC PUMP WITH A 16G BD NEEDLE TO INJECT THE DILUENT AND DRUG INTO THE BAGS. THE 16G NEEDLE IS USED FOR A MAXIMUM OF 5 PUNCTURES AND THE SECURE BAG IS BEING PUNCTURED ONLY 2 TIMES. WE USE THE SAME COMPOUNDING METHOD FOR THE ALTERNATIVE VENDOR'S BAGS AND WE DO NOT SEE THIS ISSUE." THE CUSTOMER ALSO STATED "THE 'FLOATERS' WERE OFTEN LITTLE PIECES OF PLASTIC OF VARYING SHAPES AND SIZES ("CIRCULAR", SPIRAL, OTHER SHAPES WHICH COULD HAVE MORE JAGGED EDGES). THEY WERE USUALLY TOO SMALL TO SEE OUTSIDE OF A VISUAL INSPECTION BOX, AND WERE THE SAME COLOUR AS THE EVA BAGS THEMSELVES." AS THE FLOATERS WERE NOTED AT THE FILLING PHARMACY, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501751 ↗

Other Metrix Company, The products

• CORMIX4 models · 2 reports · 3 recalls