CADD 21-7302-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,657 adverse event reports that list this exact device (DI 10610586027239), received between Mar 9, 2018 and Sep 30, 2026 — classified as 1 death, 19 injuries, 4,637 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2,411 reports).

4 FDA recall records name this device's identifier, 4 still open.

5 other recalls cover devices cleared under the same FDA submission (K040636); they may or may not involve this specific model.

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.

Recalls naming this device

1. Aug 6, 2025Open, Classified

   Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

   Z-2526-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 26, 2024Open, Classified

   Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

   Z-0011-2025 · Root cause: Process control · Recall details · FDA record ↗

3. Dec 9, 2022Open, Classified

   There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

   Z-0966-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Dec 9, 2022Open, Classified

   There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

   Z-0963-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,657 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952833 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950452 ↗
• MalfunctionSep 17, 2026Particulates

  It was reported that during bench test an oblong impurity was observed in cassette and the impurity appeared to be stationary, but it was unclear if it is inside or outside the bag part, additionally as the cassette contained a narcotic, there was no patient involvement or harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802425 ↗
• MalfunctionSep 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739986 ↗
• MalfunctionSep 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652361 ↗
• MalfunctionSep 7, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50649980 ↗
• MalfunctionJul 10, 2026Particulates

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25780561 ↗
• MalfunctionJul 9, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25769702 ↗
• MalfunctionJul 8, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25752297 ↗
• MalfunctionJul 1, 2026Air/Gas in Device

  IT WAS REPORTED THAT THERE WERE MICROBUBBLES FORMING IN CASSETTE APPROXIMATELY 10 HOURS AFTER CASSETTE ATTACHED TO PUMP. THE ISSUE WAS RESOLVED FOR A WHILE AND THEN ON (B)(6) 2026 CUSTOMER REPORTED MORE INCIDENTS OF AIR IN LINE INCLUDING 6CM OF AIR IN LINE. EVENT OCCURRED AT HOSPITAL WHILE IN USE WITH PATIENT. THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682712 ↗
• MalfunctionJun 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN ORDER WAS COMPOUNDED IN A 100 ML CASSETTE. AFTER ADDING HYDROMORPHONE AND SALINE, THE COMPOUNDER NOTICED THE CASSETTE BLADDER WAS LEAKING. THERE WAS A PATIENT INVOLVEMENT AND THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665128 ↗
• MalfunctionJun 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CADD CASSETTE BLADDER WAS OBSERVED TO LEAK DURING THE ADDITION OF MEDICATION. THIS ISSUE POSES A POTENTIAL RISK BY CREATING A HAZARDOUS SITUATION, INCLUDING POSSIBLE EXPOSURE TO THE DRUG. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566510 ↗
• MalfunctionJun 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE ADDITION OF MORPHINE AND DEXAMETHASONE AND SALINE IN A CASSETTE THE COMPOUNDER OBSERVED THAT THE CASSETTE BLADDER BEGAN TO LEAK DURING COMPOUNDING. LEAKS CAN EXPOSE A PATIENT AND/OR CLINICIAN TO MEDICATION THAT COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360019 ↗
• MalfunctionJun 1, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE BETWEEN THE CAP OR PORT OF THE CASSETTE USED IN COMPOUNDING PRODUCTION. THE QUALITY CONTROL DURING PRODUCTION INCLUDES A VISUAL VERIFICATION FOR CAP TIGHTENING AND LEAKAGE AND THE ISSUE IS NOT SEEN DURING PRODUCTION. THE ISSUE WAS DISCOVERED DURING GOODS RECEIPT OF FINISHED PRODUCT HP CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT. SAMPLE PHOTOS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350965 ↗
• MalfunctionMay 20, 2026Contamination

  IT WAS REPORTED THAT DURING VISUAL INSPECTION A PARTICLE WAS IDENTIFIED INSIDE THE CASSETTE. THE STAFF HAS IDENTIFIED THIS PARTICLE AS A CURL OF PLASTIC. THIS EVENT OCCURRED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230345 ↗
• MalfunctionMay 20, 2026Contamination

  IT WAS REPORTED THAT DURING VISUAL INSPECTION A PARTICLE WAS IDENTIFIED INSIDE THE CASSETTE. THE STAFF HAS IDENTIFIED THIS PARTICLE AS A CURL OF PLASTIC. THIS EVENT OCCURRED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230283 ↗
• MalfunctionMay 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE ADDITION OF 5000MG MORPHINE, 4MG DEXAMETHASONE, AND NORMAL SALINE IN A 100 ML CASSETTE, THE COMPOUNDER OBSERVED THAT THE CASSETTE BLADDER BEGAN TO LEAK ABOUT 1% OF THE TOTAL OF COMPOUNDED CASSETTES DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226932 ↗
• MalfunctionApr 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT (B)(4) UNITS SPLIT ON THE UPPER HALF OF THE LINER WHEN FILLING WITH 5FU. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049693 ↗
• MalfunctionApr 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT 2 UNITS SPLIT ON THE UPPER HALF OF THE LINER WHEN FILLING WITH 5FU. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049689 ↗
• MalfunctionApr 16, 2026Contamination

  IT WAS REPORTED THAT THE CASSETTE EXHIBITED BLACKISH-BROWN SPOTS ON THE INSIDE OF THE CASSETTE. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905193 ↗
• MalfunctionApr 14, 2026Contamination

  IT WAS REPORTED THAT THE CASSETTE, INSPECTED BEFORE USE (EMPTY), ONCE FILLED WITH SOLVENT AND CHEMOTHERAPY, THERE WAS A BLUE-BLACK PARTICLE AT THE LEVEL OF THE BAG. A NEW CASSETTE WAS THEN PREPARED AFTER VERIFYING THE ABSENCE OF ANY PARTICLE. A SECOND CASSETTE, BELONGING TO THE SAME LOT, ALSO PRESENTED A VISIBLE PARTICLE AT THE LEVEL OF THE BAG. IT WAS NOT POSSIBLE TO DETERMINE WHETHER THESE PARTICLES WERE INSIDE THE BAG OR LOCATED OUTSIDE OF IT, BETWEEN THE FLEXIBLE BAG AND THE RIGID STRUCTURE OF THE CASSETTE. THE TWO CASSETTES WERE NOT BROUGHT INTO CONTACT WITH CHEMOTHERAPY DUE TO THE PRIOR DETECTION OF THE PARTICLE. ISSUE OCCURRED AT THE TIME OF PREPARING CHEMOTHERAPY IN OUR PREPARATION UNIT. CASSETTE DISCARDED AND NEW CASSETTE USED FOR PREPARATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875436 ↗
• MalfunctionApr 14, 2026Contamination

  IT WAS REPORTED THAT THE CASSETTE, INSPECTED BEFORE USE (EMPTY), ONCE FILLED WITH SOLVENT AND CHEMOTHERAPY, THERE WAS A BLUE-BLACK PARTICLE AT THE LEVEL OF THE BAG. A NEW CASSETTE WAS THEN PREPARED AFTER VERIFYING THE ABSENCE OF ANY PARTICLE. A SECOND CASSETTE, BELONGING TO THE SAME LOT, ALSO PRESENTED A VISIBLE PARTICLE AT THE LEVEL OF THE BAG. IT WAS NOT POSSIBLE TO DETERMINE WHETHER THESE PARTICLES WERE INSIDE THE BAG OR LOCATED OUTSIDE OF IT, BETWEEN THE FLEXIBLE BAG AND THE RIGID STRUCTURE OF THE CASSETTE. THE TWO CASSETTES WERE NOT BROUGHT INTO CONTACT WITH CHEMOTHERAPY DUE TO THE PRIOR DETECTION OF THE PARTICLE. ISSUE OCCURRED AT THE TIME OF PREPARING CHEMOTHERAPY IN OUR PREPARATION UNIT. CASSETTE DISCARDED AND NEW CASSETTE USED FOR PREPARATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875389 ↗
• MalfunctionApr 14, 2026Contamination

  IT WAS REPORTED THAT ONCE FILLED WITH SOLVENT AND CHEMOTHERAPY, THE PRESENCE OF A BLUE OR BLACK COLORED PARTICLE WAS OBSERVED IN THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875274 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LEAKAGE IN 4 CADD CASSETTES DURING COMPOUNDING. AFTER INJECTING MEDICATION, THEY OBSERVED THAT THE CASSETTES WERE LEAKING FROM THE INTERNAL BAG WITHIN THE CASSETTE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24864930 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LEAKAGE IN 4 CADD CASSETTES DURING COMPOUNDING. AFTER INJECTING MEDICATION, THEY OBSERVED THAT THE CASSETTES WERE LEAKING FROM THE INTERNAL BAG WITHIN THE CASSETTE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24864921 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040636. One submission often covers many models, so check the product and lot details in each record.

• Z-2522-2025 · Aug 6, 2025 · Open, Classified
  Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
• Z-1767-2017 · Mar 17, 2017 · Terminated
  CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
• Z-1831-2016 · Apr 22, 2016 · Terminated
  CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24
• Z-1286-2015 · Feb 2, 2015 · Terminated
  CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
• Z-0879-2008 · Dec 14, 2007 · Terminated
  Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Pa