RegWardenFDA facility compliance records
Recall

Class II — Angiodynamics, Inc.

Recalling firmANGIODYNAMICS, INC
Registered facilityView this company's 4 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonCertain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
ProductBioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161 H965460161-NP H965460171 H965460181 H965460221 H965460231 H965460241 H965460251 H965460261 H965460271 H965460281 H965460291 H965464601 H965464701 H965464701-NP H965464801 H965464901 Cat. No. 46-015 46-016 46-016-NP 46-017 46-018 46-022 46-023 46-024 46-025 46-026 46-027 46-028 46-029 46-460 46-470 …
Quantity119723 eaches total
DistributionUS Nationwide distribution.
Initiated2020-05-04
Classified2020-06-17
Terminated2023-08-23
Recall numberZ-2395-2020
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Angiodynamics, Inc. (Z-2395-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85631/

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