IV Administration SetRecalls & reported problems across all models
B. Braun Medical Inc. · 153 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
67 open recalls name at least one IV Administration Set model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 281
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 68
We found 153 models of IV Administration Set by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 281 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2016 and Sep 25, 2026 — classified as 281 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (111 reports).
68 FDA recall records name at least one of these models by its device identifier, 67 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
Reports received per month, all models
IV Administration 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.
- 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-0718-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0717-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0705-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0704-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0703-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0702-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- 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-0701-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0700-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- 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-0699-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0698-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0697-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0696-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0695-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- 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-0694-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0693-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0692-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0691-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0690-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0689-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0688-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0687-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0686-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0685-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- 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-0684-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0683-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0682-2026 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗
- 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-0681-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0680-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0679-2026 · Root cause: Process control · Recall details · FDA record ↗
- 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-0678-2026 · Root cause: Process control · Recall details · FDA record ↗
…and 38 older recalls, listed on each model's page.
Most reported IV Administration Set problems
Device problems
- Leak/Splash111
- Fluid/Blood Leak68
- Contamination /Decontamination Problem28
- Air/Gas in Device17
- Free or Unrestricted Flow13
- Labelling, Instructions for Use or Training Problem13
- Device Operates Differently Than Expected9
- Inaccurate Flow Rate8
Patient problems
- No Clinical Signs, Symptoms or Conditions170
- No Known Impact Or Consequence To Patient53
- No Consequences Or Impact To Patient35
- Hemorrhage/Blood Loss/Bleeding7
- Blood Loss6
- Chemical Exposure4
- Dyspnea3
- Fall2
IV Administration Set models
153 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- IV Administration Set 480239Set, administration, intravascular1 recall67 reports
- IV Administration Set V1921Set, administration, intravascular84 reports
- IV Administration Set 470005Set, administration, intravascular1 recall15 reports
- IV Administration Set 352636Set, administration, intravascular1 recall13 reports
- IV Administration Set 354210Set, administration, intravascular1 recall10 reports
- IV Administration Set 490067Stopcock, i.V. Set1 recall9 reports
- IV Administration Set 352643Set, administration, intravascular1 recall6 reports
- IV Administration Set 352640Set, administration, intravascular1 recall4 reports
- IV Administration Set 490340Set, administration, intravascular1 recall4 reports
- IV Administration Set 490578Set, administration, intravascular1 recall3 reports
- IV Administration Set 490432Stopcock, i.V. Set1 recall3 reports
- IV Administration Set 490521Set, administration, intravascular1 recall2 reports
- IV Administration Set 490552Set, administration, intravascular1 recall2 reports
- IV Administration Set 354211Stopcock, i.V. Set1 recall2 reports
- IV Administration Set 490329Stopcock, i.V. Set1 recall2 reports
- IV Administration Set 457515Set, administration, intravascular1 recall2 reports
- IV Administration Set 490605Set, administration, intravascular1 recall1 report
- IV Administration Set 354208Stopcock, i.V. Set1 recall1 report
- IV Administration Set 490025Set, administration, intravascular1 recall1 report
- IV Administration Set 490225Stopcock, i.V. Set1 recall1 report
- IV Administration Set 457506Set, administration, intravascular1 recall1 report
- IV Administration Set 490427Set, administration, intravascular1 recall1 report
- IV Administration Set 480231Set, administration, intravascular1 recall0 reports
- IV Administration Set 490492Stopcock, i.V. Set1 recall0 reports
- IV Administration Set 490487Stopcock, i.V. Set1 recall0 reports
- IV Administration Set 490488Set, administration, intravascular1 recall0 reports
- IV Administration Set 490489Set, administration, intravascular1 recall0 reports
- IV Administration Set 490491Syringe, piston1 recall0 reports
- IV Administration Set 490503Stopcock, i.V. Set1 recall0 reports
- IV Administration Set 490504Stopcock, i.V. Set1 recall0 reports
- IV Administration Set 490507Set, administration, intravascular1 recall0 reports
- IV Administration Set 490508Stopcock, i.V. Set1 recall0 reports
- IV Administration Set 490511Stopcock, i.V. Set1 recall0 reports
- IV Administration Set 490513Set, administration, intravascular1 recall0 reports
- IV Administration Set 490519Stopcock, i.V. Set1 recall0 reports
- IV Administration Set 477002Set, administration, intravascular1 recall0 reports
- IV Administration Set 477006Set, administration, intravascular1 recall0 reports
- IV Administration Set 477003Set, administration, intravascular1 recall0 reports
- IV Administration Set 477008Set, administration, intravascular1 recall0 reports
- IV Administration Set 477012Set, administration, intravascular1 recall0 reports
- IV Administration Set 477017Set, administration, intravascular1 recall0 reports
- IV Administration Set 490522Set, administration, intravascular1 recall0 reports
- IV Administration Set 477019Set, administration, intravascular1 recall0 reports
- IV Administration Set 490527Set, administration, intravascular1 recall0 reports
- IV Administration Set 490528Set, administration, intravascular1 recall0 reports
- IV Administration Set 490529Set, administration, intravascular1 recall0 reports
- IV Administration Set 490535Set, administration, intravascular1 recall0 reports
- IV Administration Set 477021Set, administration, intravascular1 recall0 reports
- IV Administration Set 477022Set, administration, intravascular1 recall0 reports
- IV Administration Set 477023Set, administration, intravascular1 recall0 reports
- IV Administration Set 490542Set, administration, intravascular1 recall0 reports
- IV Administration Set 490543Set, administration, intravascular1 recall0 reports
- IV Administration Set 490546Set, administration, intravascular1 recall0 reports
- IV Administration Set 490547Set, administration, intravascular1 recall0 reports
- IV Administration Set 490549Set, administration, intravascular1 recall0 reports
- IV Administration Set 490550Set, administration, intravascular1 recall0 reports
- IV Administration Set 490551Set, administration, intravascular1 recall0 reports
- IV Administration Set 490553Set, administration, intravascular1 recall0 reports
- IV Administration Set 490554Set, administration, intravascular1 recall0 reports
- IV Administration Set 490555Set, administration, intravascular1 recall0 reports
- IV Administration Set 490558Set, administration, intravascular1 recall0 reports
- IV Administration Set 490559Set, administration, intravascular1 recall0 reports
- IV Administration Set 490560Set, administration, intravascular1 recall0 reports
- IV Administration Set 490561Set, administration, intravascular1 recall0 reports
- IV Administration Set 490562Set, administration, intravascular1 recall0 reports
- IV Administration Set 490563Set, administration, intravascular1 recall0 reports
- IV Administration Set 490565Set, administration, intravascular1 recall0 reports
- IV Administration Set 490566Set, administration, intravascular1 recall0 reports
- IV Administration Set 490568Set, administration, intravascular1 recall0 reports
- IV Administration Set 490569Set, administration, intravascular1 recall0 reports
- IV Administration Set 490573Set, administration, intravascular1 recall0 reports
- IV Administration Set 490574Set, administration, intravascular1 recall0 reports
- IV Administration Set 490575Set, administration, intravascular1 recall0 reports
- IV Administration Set 490581Set, administration, intravascular1 recall0 reports
- IV Administration Set 490582Set, administration, intravascular1 recall0 reports
- IV Administration Set 490583Set, administration, intravascular1 recall0 reports
- IV Administration Set 490588Set, administration, intravascular1 recall0 reports
- IV Administration Set 490589Set, administration, intravascular1 recall0 reports
- IV Administration Set 490600Set, administration, intravascular1 recall0 reports
- IV Administration Set 490607Set, administration, intravascular1 recall0 reports
- IV Administration Set 490608Set, administration, intravascular1 recall0 reports
- IV Administration Set 352639Set, administration, intravascular1 recall0 reports
- IV Administration Set 490612Set, administration, intravascular1 recall0 reports
- IV Administration Set 490615Set, administration, intravascular1 recall0 reports
- IV Administration Set 490616Set, administration, intravascular1 recall0 reports
- IV Administration Set 490618Set, administration, intravascular1 recall0 reports
- IV Administration Set 490619Set, administration, intravascular1 recall0 reports
- IV Administration Set 477053Set, administration, intravascular1 recall0 reports
- IV Administration Set 490644Set, administration, intravascular1 recall0 reports
- IV Administration Set 490653Set, administration, intravascular1 recall0 reports
- IV Administration Set 490654Set, administration, intravascular1 recall0 reports
- IV Administration Set 490657Set, administration, intravascular1 recall0 reports
- IV Administration Set 490658Set, administration, intravascular1 recall0 reports
- IV Administration Set 354209Set, administration, intravascular1 recall0 reports
- IV Administration Set NF1270ASet, administration, intravascular1 recall0 reports
- IV Administration Set 352394Set, administration, intravascular1 recall0 reports
- IV Administration Set 490062ACCESSORIES, CATHETER1 recall0 reports
- IV Administration Set 490070Set, administration, intravascular1 recall0 reports
- IV Administration Set 490088Stopcock, i.V. Set1 recall0 reports
- IV Administration Set 490107Stopcock, i.V. Set1 recall0 reports
Recent IV Administration Set adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Leak/Splash
As reported by the user facility:User reports an incident involving a tubing vent failure that resulted in a chemo spill.No injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896571 ↗MalfunctionSep 22, 2026Leak/Splash
As reported by the user facility:The manifold disconnected from the tubing while the patient was asleep. The RN went into the room and noted the disconnected tubing, and a significant amount of blood loss was noted.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50853378 ↗MalfunctionJun 15, 2026Inaccurate Flow Rate
AS REPORTED BY THE USER FACILITY: SECONDARY SET HAD A FAULTY ROLLER CLAMP AND LOCK DOES NOT SEAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25500787 ↗MalfunctionJun 5, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: CUSTOMER HAD IV TUBING SNAP OFF AT A HUB IN THE OR TODAY, IN THE MIDDLE OF A PATIENT'S ANESTHETIC INDUCTION. NOTHING HAPPENED TO CAUSE IT TO BREAK - THE HUB WASN'T EVEN BEING USED. FLUIDS AND BLOOD WENT ALL OVER THE FLOOR, BLOOD BACKED UP INTO THE IV, AND IT DELAYED SURGICAL START, BUT THE PATIENT WAS NOT HARMED. THE IV TUBING WAS REPLACED AT THE IV SITE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25406770 ↗MalfunctionJun 1, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: THE TUBING SPLIT DURING CHEMO INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354702 ↗MalfunctionMay 21, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: THE HOSPITAL IS EXPERIENCING ISSUES WITH THE B BRAUN SECONDARY IV ADMINISTRATION SETS, WHERE THE CAPS ARE POPPING OFF DURING CHEMOTHERAPY ADMINISTRATION, RESULTING IN CHEMO SPILLS.
Patient problems: Chemical Exposure
MAUDE report 25244128 ↗MalfunctionMay 14, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: RNS ARE PULLING THE VENT OUT OF TUBING CAUSING MEDICATIONS TO SPILL OUT. AT THE END OF A SECONDARY INFUSION, NURSES WILL FLIP OPEN THE VENT IN THE DRIP CHAMBER TO HELP PUSH THROUGH THE REMAINING FLUID. THIS IS WHEN THEY FEEL THE BAG HAS COLLAPSED AND CHEMO SPILLED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179372 ↗MalfunctionMay 14, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: RNS ARE PULLING THE VENT OUT OF TUBING CAUSING MEDICATIONS TO SPILL OUT. AT THE END OF A SECONDARY INFUSION, NURSES WILL FLIP OPEN THE VENT IN THE DRIP CHAMBER TO HELP PUSH THROUGH THE REMAINING FLUID. THIS IS WHEN THEY FEEL THE BAG HAS COLLAPSED AND CHEMO SPILLED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179369 ↗MalfunctionMay 13, 2026Detachment of Device or Device Component; Infusion or Flow Problem; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: THE GAS VALVE FAILED, ALLOWING BUBBLES IN THE LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25159326 ↗MalfunctionMay 11, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: SPIKE PORT HAS A MARK ON IT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25142870 ↗MalfunctionMay 4, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: DESCRIPTION SUMMARY: THE AREA WHERE THE BLUE AND CLEAR GO TOGETHER COMES APART. WE HAD PATIENT'S BLOOD EVERYWHERE ALL OVER THE BED AND FLOOR AND THE OTHER ONE WAS IV FLUID THAT WENT EVERYWHERE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071815 ↗MalfunctionMay 3, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1, DESCRIPTION SUMMARY: THE AREA WHERE THE BLUE AND CLEAR GO TOGETHER COMES APART. WE HAD PATIENT'S BLOOD EVERYWHERE ALL OVER THE BED AND FLOOR AND THE OTHER ONE WAS IV FLUID THAT WENT EVERYWHERE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062887 ↗MalfunctionMay 1, 2026Leak/Splash; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: SALES REP REPORTED THAT THE STAFF FOUND THAT THERE WERE TOO MANY AIR BUBBLES IN THE IV SET THAT THEY COULDN'T GET OUT, AND THAT IT LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055878 ↗MalfunctionApr 7, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: BLOOD IS COMING BACK UP FROM THE PATIENT AND "POURING" OUT NEAR THE VALVE, IT IS MORE THAN A DRIP.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24810206 ↗MalfunctionApr 2, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: AFTER OPENING THE VENT ON THE VINCRISTINE BAG, CHEMO WAS NOTED TO BE LEAKING FROM THE BAG. INITIALLY, THE SOURCE OF THE LEAK COULD NOT BE IDENTIFIED, AND THE SECONDARY LINE WAS CLAMPED. THE LEAK PERSISTED, AND IT WAS SUBSEQUENTLY DETERMINED THAT THE LEAK WAS ORIGINATING FROM THE VENT OF THE CHEMOTHERAPY BAG. THE BAG WAS IMMEDIATELY GRASPED, TURNED UPSIDE DOWN, AND REMOVED FROM THE Y-PORT OF THE PRIMARY LINE. THE IV PUMP WAS CHANGED AND NEW LINES PRIMED FOR THE PATIENT. A SPILL KIT WAS UTILIZED TO CLEAN CHEMOTHERAPY FROM THE FLOOR AND THE IV PUMP. THE FLOOR WAS THEN FURTHER CLEANED WITH SPA AND WATER AND THEN DISINFECTED WITH PURPLE WIPES. THE IV PUMP WAS COVERED WITH A YELLOW (CHEMO) BIOHAZARD BAG AND PLACED IN THE DIRTY UTILITY ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24764876 ↗
Other B. Braun Medical Inc. products
- Infusomat54 models · 2,783 reports · 30 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
- Caresite23 models · 420 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page