AngioDynamics BioFlo Port Recall Due to Incorrect Sterile Assembly
AngioDynamics is recalling BioFlo Ports that were partially manufactured with the wrong sterile port assembly. The devices were distributed in Indiana.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a manufacturing error where the wrong sterile assembly was used, but the source text does not report any illnesses, injuries, or specific health hazards, fitting the criteria for a moderate severity recall.
Plain-English summary
AngioDynamics Inc. (Navilyst Medical Inc.) is recalling BioFlo Ports with ENDEXO and PASV Technology (Catalog Number: 44-021, Lot Number: 5363172). The recall was initiated because the devices were partially manufactured with the incorrect sterile port assembly.
The affected units were intended to use an 8F SL BioFlo Plastic Valved Non-Filled assembly but were instead manufactured with an 8F SL Xcela Plus Titanium Valved Non-Filled assembly. These ports are used for long-term access to the central venous system for the administration of fluids, chemotherapy, and other medical treatments.
The recall covers units distributed in Indiana. The source text does not specify the number of units affected or report any illnesses or injuries associated with the incorrect assembly.
The recalled product
- Product
- BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited…
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 5363172
Distribution
Related recalls
Same manufacturer · Angiodynamics Inc. (Navilyst Medical Inc.)
See all →- ModerateXcela PICC catheter mislabeled with incorrect size designation
FDA (Devices) · 2021-10-06
- SevereAngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-04-28
- HighAngioDynamics Recalls Implantable Infusion Port Kits Due to Sterility Concerns
FDA (Devices) · 2021-04-28
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters
FDA (Devices) · 2019-11-27
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports
FDA (Devices) · 2019-11-27
Same hazard · manufacturing error
See all →- HighTRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
- HighStraumann angled custom abutments made from wrong bar material
FDA (Devices) · 2026-04-01
- HighStraumann custom abutments made from wrong bar material after mix-up
FDA (Devices) · 2026-04-01
- HighMedtronic tissue stabilizer recalled after tubing was assembled in reverse
FDA (Devices) · 2026-03-04
- HighDASH COVID and flu tests may give a false negative result
FDA (Devices) · 2025-08-13
Similar recalls
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Filled Non-Valved Ports
FDA (Devices) · 2019-11-27
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Non-Filled Valved Ports
FDA (Devices) · 2019-11-27
- ModerateAngiodynamics Recalls BIOFLO 8F Single Titanium Non-Filled Valved Ports
FDA (Devices) · 2019-11-27
- ModerateAngiodynamics Recalls BIOFLO 8F Single Plastic Filled Valved Catheters
FDA (Devices) · 2019-11-27
- HighAngioDynamics Recalls Implantable Infusion Port Kits Due to Sterility Concerns
FDA (Devices) · 2021-04-28
- ModerateAngiodynamics Recalls XCELA Implantable Port Kits Due to Connector Defect
FDA (Devices) · 2019-11-27