Anesthesia IV SetRecalls & reported problems across all models

We found 11 models of Anesthesia IV Set by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2018 and Oct 2, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

9 FDA recall records name at least one of these models by its device identifier, 9 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

Anesthesia IV Set 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 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0614-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0613-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0612-2026 · Root cause: Process control · Recall details · FDA record ↗

4. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0611-2026 · Root cause: Process control · Recall details · FDA record ↗

5. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0610-2026 · Root cause: Process control · Recall details · FDA record ↗

6. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0609-2026 · Root cause: Process control · Recall details · FDA record ↗

7. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0608-2026 · Root cause: Process control · Recall details · FDA record ↗

8. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0607-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

9. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0606-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

Most reported Anesthesia IV Set problems

Anesthesia IV Set models

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

• Anesthesia IV Set 490189

  Set, administration, intravascular
  1 recall1 report
• Anesthesia IV Set 490452

  Set, administration, intravascular
  1 recall1 report
• Anesthesia IV Set 490226

  Stopcock, i.V. Set
  1 recall0 reports
• Anesthesia IV Set 490444

  Set, administration, intravascular
  1 recall0 reports
• Anesthesia IV Set 490467

  Stopcock, i.V. Set
  1 recall0 reports
• Anesthesia IV Set 490468

  Set, administration, intravascular
  1 recall0 reports
• Anesthesia IV Set 490469

  Set, administration, intravascular
  1 recall0 reports
• Anesthesia IV Set 490470

  Stopcock, i.V. Set
  1 recall0 reports
• Anesthesia IV Set 490472

  Set, administration, intravascular
  1 recall0 reports
• Anesthesia IV Set 490476

  Set, administration, intravascular
  1 recall0 reports
• Anesthesia IV Set 490477

  Stopcock, i.V. Set
  1 recall0 reports

Recent Anesthesia IV Set adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2020Improper Flow or Infusion; Improper Flow or Infusion

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET DISCONNECTED AT THE NON-BONDED PORTION WHEN ATTEMPTING TO CONNECT A SYRINGE TO THE STOPCOCK CAUSING AIR IN LINE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10618718 ↗
• MalfunctionSep 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: DURING THERAPY, IT WAS REPORTED THAT THE PRIMARY SET DISCONNECTION CAUSED THE PATIENT TO BLEED OUT FROM THE IV SET. NO INJURY REPORTED.

  Patient problems: Blood Loss

  MAUDE report 7889719 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
• IV Administration Set153 models · 281 reports · 68 recalls
• Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
• Outlook25 models · 195 reports · 24 recalls
• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Blood Administration Set24 models · 177 reports · 13 recalls