Food, drugs, devices › Angiodynamics, Inc.
Device recall: PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx1
Angiodynamics, Inc. (Queensbury, NY) initiated this device recall on 18 Dec 2023; FDA lists 1 product record under event 93744, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Angiodynamics, Inc. has 24 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Angiodynamics, Inc., Queensbury, NY.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1010-2024 | 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. | 7 eaches | Class II | Ongoing | 14 Feb 2024 |
Context
Other enforcement events for Angiodynamics, Inc.
All 24 events for Angiodynamics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "United States (MD, LA & UT), Austria, Canada and Spain."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.