HospiraRecalls & reported problems across all models

We found 5 models of Hospira by ICU Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Dec 3, 2019 and Sep 18, 2026 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Particulates” (27 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 Hospira problems

Hospira models

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

• Hospira 795112

  CONTAINER, I.V.
  20 reports
• Hospira 1422028

  Set, administration, intravascular
  19 reports
• Hospira 795123

  CONTAINER, I.V.
  12 reports
• Hospira 795113

  CONTAINER, I.V.
  4 reports
• Hospira 1269402

  Set, administration, intravascular
  1 report

Recent Hospira adverse event reports

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

• MalfunctionSep 18, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829092 ↗
• MalfunctionMay 14, 2026Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING A PRIMARY PLUM Y-TYPE BLOOD SET IN WHICH IT WAS REPORTED THAT THERE WAS LEAKAGE FROM THE DRIP CHAMBER. THE ISSUE WAS NOTED DURING INFUSION. THERE WAS NO BLEEDBACK, NO BIOHAZARD, NO USER FACILITY MEDWATCH, AND NO CHEMO. THERE WAS PATIENT INVOLVEMENT, BUT NO DELAY IN CRITICAL THERAPY AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178835 ↗
• MalfunctionFeb 24, 2026Particulates

  EVENT OCCURRED REGARDING AN EMPTY LIFECARE CONTAINER 100 ML SIZE WHERE THEY REPORTED THAT THEY HAVE BEEN SEEING FIBER LIKE MATERIAL FLOATING IN POST-PRODUCTION PRODUCT. PREMIXED DRUGS THEY ARE MANUFACTURING - FENTANYL, KETAMINE, HYDROMORPHONE. THEY HAVE NOT HAD ANY INCIDENTS WITH PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24437587 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50422) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408026 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50623) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408024 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR HYDROMORPHONE (BATCH: 50953) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406226 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH: 50944) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406028 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50831) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402727 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50402) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402705 ↗
• MalfunctionFeb 20, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR KETAMINE (BATCH 49968) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402281 ↗
• MalfunctionFeb 19, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR KETAMINE (BATCH 50161) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397249 ↗
• MalfunctionFeb 19, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR KETAMINE (BATCH 50675) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397246 ↗
• MalfunctionFeb 19, 2026Particulates

  A COMPLAINT WAS RECEIVED REGARDING EMPTY LIFECARE CONTAINER 100 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR KETAMINE (BATCH 50837) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397238 ↗
• MalfunctionFeb 19, 2026Particulates

  A COMPLAINT WITH RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50632 ) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395265 ↗
• MalfunctionFeb 19, 2026Particulates

  A COMPLAINT WITH RECEIVED A COMPLAINT REGARDING EMPTY LIFECARE CONTAINER 250 ML SIZE IN WHICH IT WAS STATED THE PREPARATION FOR FENTANYL (BATCH 50660) WAS INSPECTED AND PARTICULATE MATTER WAS FOUND IN THE LIFECARE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395251 ↗

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