Angiodynamics, Inc. 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Angiodynamics, Inc.
Lot Codes / Batch Numbers
UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345, UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480, UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.
Products Sold
UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.
Angiodynamics, Inc. is recalling PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 125004 due to Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
Recommended Action
Per FDA guidance
An Urgent Medical Voluntary Medical Device notices dated December 18, 2023 was issued to distributors and end users with instructions to immediately stop using affected product, remove said product from inventory and return to AngioDynamics, Inc. The notice should be forwarded to all site affected product may have been distributed to and recipients are asked to complete and return the Reply Verification Tracking Form. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026