# FDA recall Z-1010-2024

> **Angiodynamics, Inc.** · Class II · device recall initiated 2023-12-18.

## Product

PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN:  H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235,  REF: 12500423.

## Reason for recall

Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.

## Distribution

United States (MD, LA & UT), Austria, Canada and Spain.

## Key facts

- **Recall number:** Z-1010-2024
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-18
- **Report date:** 2024-02-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Queensbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2024

## Citation

> AI Analytics. FDA recall Z-1010-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1010-2024. Source: US FDA. Licensed CC0.

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