IV Administration Set utilized in gravity IV administration sets and pump administration sets uti...

FDA Device Recall #Z-0665-2026 — Class II — October 29, 2025

Recall Summary

Recall Number Z-0665-2026
Classification Class II — Moderate risk
Date Initiated October 29, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm B Braun Medical Inc
Location Bethlehem, PA
Product Type Devices
Quantity 3,120 units

Product Description

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15DR, 92 IN W/EXT SET 9 IN.; Catalog Number: 490489.

Reason for Recall

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

Distribution Pattern

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

Lot / Code Information

1. Catalog Number: 490489; Primary UDI-DI: 04046955086894; Unit of Dose UDI-DI: 04046955086887.

Other Recalls from B Braun Medical Inc

Recall # Classification Product Date
Z-1481-2026 Class II Brand Name: B. Braun Product Name: BBraun Medi... Feb 2, 2026
Z-1482-2026 Class II Brand Name: B. Braun Product Name: 21GA WINGED... Feb 2, 2026
Z-1483-2026 Class II Brand Name: B. Braun Product Name: 21GA WINGED... Feb 2, 2026
Z-0656-2026 Class II IV Administration Set utilized in gravity IV ad... Oct 29, 2025
Z-0708-2026 Class II Outlook set utilized in gravity IV administrati... Oct 29, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.