Severity
Moderate
FDA Devices recall · Reported December 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical Inc recalled Vista set utilized in gravity IV administration sets and pump administration sets utilize… - a moderate-severity action.
Vista set utilized in gravity IV administration sets and pump administration sets utilize… was recalled by B Braun Medical Inc in December 3, 2025. Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and …. Check the official notice for the remedy. Verify recall #Z-0715-2026 with the FDA Devices before acting.
The recall
B Braun Medical Inc issued this moderate-severity FDA Devices recall-Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and ….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0715-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0715-2026) 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 list the affected scope as 74,652 units.
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
74,652 units
Related Recalls
6
3 from same agency
Vista 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. VISTA BASIC PUMP IV SET W/ 15 DROP/ML; Catalog Number: US9923F.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0715-2026 |
| Date reported | December 3, 2025 |
| Date initiated | October 29, 2025 |
| Recalling firm | B Braun Medical Inc |
| Firm location | Bethlehem, PA |
| Affected scope | 74,652 units |
| Distribution | Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 3, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.