HIGHFDA DEVICE

B Braun Vista IV Set Recall for 74,652 Units Over Backflow and Occlusion Risk

B Braun Medical Inc recalls 74,652 Vista IV sets used with Infusomat Space and Vista Basic Pumps due to backflow and occlusion risks. The recall affects devices distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore. Stop using the device immediately and follow manufacturer instructions.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
October 29, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
October 29, 2025
Hazard Level
HIGH
Brands
BBraun Medical, B Braun Medical, B Braun Medical Inc
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL, PREGNANT, PREGNANT

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
BBraun Medical, B Braun Medical, B Braun Medical Inc
Product type
IV administration sets (Vista set)
Model numbers
US9923F
Sizes
15 DROP/ML
Sold at
Multiple Retailers

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    October 29, 2025

  2. Reported by FDA DEVICE

    December 3, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter

About This Product

Vista IV sets are used in gravity and pump-based IV administration. They connect to IV bags and piggyback containers to deliver medications.

Why This Is Dangerous

Backflow can contaminate the primary IV line and occlusion can prevent proper flow of medications, potentially delaying treatment.

Industry Context

This recall is not stated as part of a broader industry pattern.

Real-World Impact

Immediate stop-use is required to prevent potential interruptions in IV therapy and contamination risk.

Practical Guidance

How to identify if yours is affected

  1. Check the catalog number US9923F on the Vista Basic Pump IV Set W/ 15 DROP/ML.
  2. Inspect the UDI-DI 04046964838156 for the Primary and 04046964838149 for the Unit of Dose.
  3. Confirm expiration date within 36 months of manufacture.

Where to find product info

Recall page and FDA enforcement report Z-0715-2026.

What timeline to expect

4-6 weeks for refunds or replacements, depending on supplier and facility processes.

If the manufacturer is unresponsive

  • Escalate to facility compliance office
  • File a complaint with CPSC if applicable
  • Consult legal counsel for coverage concerns

How to prevent similar issues

  • Verify compatibility with Infusomat Space and Vista pumps before use
  • Use strict IV administration protocols to avoid backflow
  • Regularly audit IV sets for occlusion indicators

Documentation advice

Document recall notice, catalog US9923F, UDIs, expiration dates, and replacement records.

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Product Details

Brand: B Braun Medical Inc. Product: Vista Basic Pump IV Set W/ 15 DROP/ML; Catalog Number US9923F. UDI-DI: 04046964838156. Unit of Dose UDI-DI: 04046964838149. Expiration: Earliest expiration date or 36 months from manufacture. Quantity: 74,652 units. Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore.

Reported Incidents

No specific injuries or incidents are cited in the provided data. The status is ACTIVE with HIGH hazard level.

Key Facts

  • Catalog Number US9923F
  • Exposure worldwide incl. US, Canada, Germany, Guatemala, Singapore
  • High hazard level

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPREGNANTPREGNANT
Injury Types
LACERATIONOTHER

Product Classification

Product Details

Model Numbers
US9923F
Report Date
December 3, 2025
Recall Status
ACTIVE

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