Lower riskMedical device recall · FDA · Published July 24, 2018
Angiodynamics BioFlo Port Recall: Incorrect Sterile Port Assembly Risk
Angiodynamics recalls BioFlo 8F ports with incorrect sterile port assembly. This could lead to infection or other complications during medical use. Affected units include specific lot numbers and catalog codes.
BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled
Take action
Contact the company
📍Recalling firmAngiodynamics Inc. (Navilyst Medical Inc.)10 Glens Falls Tech Park · Glens Falls, NY 12801-3864
“Angiodynamics BioFlo Port Recall: Incorrect Sterile Port Assembly Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70302-angiodynamics-bioflo-port-recall-incorrect-sterile-port-assembly-risk. Based on FDA recall #Z-0076-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0076-2019%22&limit=1).
The FDA announced on July 24, 2018, that Angiodynamics Inc. voluntarily recalled BioFlo Ports with ENDEXO and PASV Technology due to incorrect sterile port assemblies. The agency issued recall number Z-0076-2019 for the Class II device.
How to tell if you have it
Brand: Angiodynamics
Product: BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG
UPN: H965440210
Catalog Number: 44-021
Lot Number: 5363172
The hazard
According to the FDA, the BioFlo Ports were partially manufactured with the incorrect sterile port assembly. The actual assembly used was an 8F SL Xcela Plus Titanium Valved Non-Filled instead of the required 8F SL BioFlo Plastic Valved Non-Filled.
Context
GovInfoNow's records show Angiodynamics Inc. (Navilyst Medical Inc.) has 8 other recalls on record since Oct. 17, 2017. Other recent recalls of similar products include Merit Medical BioFlo DuraMax Catheter Recall: Design Defect May Cause Bleeding (Feb. 13, 2026), Medtronic Octopus Nuvo Tissue Stabilizer Recall: Incorrect Tube Assembly (Jan. 13, 2026), and Medtronic Octopus 4 Tissue Stabilizer Model 29400 Recall: Incorrect Tubing Assembly (May 12, 2026).
How to tell if you have this one
Check for the catalog number 44-021 and lot number 5363172 on the BioFlo port packaging. The product is sold under the brand name Angiodynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED.
Brand
Angiodynamics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the catalog number 44-021 and lot number 5363172 on the BioFlo port packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide in the state of IN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0076-2019 (July 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0076-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.