---
title: "PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H78... — FDA record Z-1010-2024 | Is It on Recall"
description: "Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication."
url: https://isitonrecall.com/recall/fda-device-z-1010-2024-pulsespray-infusion-system-devices-including-pulse-spray-5f-135-20-upn-h787125004045-ref-12500404-pu/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3... — FDA record Z-1010-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 18, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
- **Classification**: Class II
- **Recalling firm**: Angiodynamics, Inc.
- **Quantity**: 7 eaches
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1010-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1010-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Utah](https://isitonrecall.com/state/utah/)

## Dates in the source

- **Report date**: Feb 14, 2024
- **Recall initiation date**: Dec 18, 2023
- **Center classification date**: Feb 7, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1010-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Angiodynamics, Inc. records](https://isitonrecall.com/brand/angiodynamics-inc/)