Use cautionMedical device recall · FDA · Published December 18, 2023
Angiodynamics PulseSpray Infusion System Recall: Medication Leak Risk
Angiodynamics recalls PulseSpray Infusion Systems with a manufacturing defect that may cause medication leaks during use. Affected models include PULSE SPRAY 5F/135/20 and others. Stop using immediately to prevent potential medication leaks.
“Angiodynamics PulseSpray Infusion System Recall: Medication Leak Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56545-angiodynamics-pulsespray-infusion-system-recall-medication-leak-risk. Based on FDA recall #Z-1010-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1010-2024%22&limit=1).
The FDA announced on Dec. 18, 2023, that Angiodynamics, Inc. is voluntarily recalling PulseSpray Infusion System devices due to a rotating adaptor O-ring defect that may cause medication leaks during use.
The recall involves a rotating adaptor O-ring manufacturing defect that impacts seal integrity, which may lead to a leak during the infusion of medication.
Context
GovInfoNow's records show Angiodynamics, Inc. has had 18 other recalls since June 5, 2017. Recent brand recalls include an AccuVu Catheter recall on March 3, 2026, for guidewire passage issues, an IsoLoc Prostate Balloon Kit recall on Feb. 4, 2025, for mislabeling, and an Auryon Laser System recall on Nov. 25, 2024, for potential procedural delays. Other recent recalls of similar products include an ICU Medical CADD Yellow Medication Cassette Reservoir Recall on Aug. 20, 2026, and Medline Medical Kits Recalls on Feb. 27, 2026.
How to tell if you have this one
Check for model numbers like PULSE SPRAY 5F/135/20, UPN: H787125004045, or REF: 12500404. The recall includes specific production lots and unique identifiers listed in the official notice.
Brand
Angiodynamics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify your PulseSpray Infusion System model number and production lot to confirm if it is affected.
Stop Using Immediately
If your device is affected, stop using it to prevent medication leaks during infusion.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “United States (MD, LA & UT), Austria, Canada and Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Louisiana, Maryland, Utah.
Recall timeline
FDA published this recall 58 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1010-2024 (December 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1010-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.