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 W/15 DROPS/ML, 133 IN.; Catalog Number: 490245.

Recall Insight

This FDA Devices action (record #Z-0676-2026) was formally reported on December 3, 2025, with the manufacturer initiating the action on October 29, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. B Braun Medical Inc is listed as the recalling firm, operating out of Bethlehem, PA. Federal records indicate 40,992 units units are affected.

The documented reason for this recall is: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Distribution data in the federal record shows the product reached: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.