Exact FDA event identifier

Event 94349

15 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 18, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Angiodynamics, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

15 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 15

DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015

Z-1760-2024

Recall number: Z-1760-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 455 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 25051684014738 Lot Numbers: 5807192, 5807197

Distribution pattern

device · product 2 of 15

DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021

Z-1761-2024

Recall number: Z-1761-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 157 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 15051684014748 Lot Numbers: 5805837

Distribution pattern

device · product 3 of 15

DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035

Z-1762-2024

Recall number: Z-1762-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 35 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 25051684014752 Lot Numbers: 5805839

Distribution pattern

device · product 4 of 15

DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115

Z-1763-2024

Recall number: Z-1763-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 188 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI:15051684014786 Lot Numbers: 5805171

Distribution pattern

device · product 5 of 15

DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012185

Z-1764-2024

Recall number: Z-1764-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 83 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 25051684014820 Lot Numbers: 5805849

Distribution pattern

device · product 6 of 15

DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195

Z-1765-2024

Recall number: Z-1765-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 65 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 25051684014837 Lot Numbers: 5807415

Distribution pattern

device · product 7 of 15

DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031

Z-1766-2024

Recall number: Z-1766-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 50 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 15051684011839 Lot Numbers: 5809463

Distribution pattern

device · product 8 of 15

DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035

Z-1767-2024

Recall number: Z-1767-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 555 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 25051684011836 Lot Numbers: 5807194, 5809616, 5809462

Distribution pattern

device · product 9 of 15

DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041

Z-1768-2024

Recall number: Z-1768-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 30 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 15051684011846 Lot Numbers: 5805840

Distribution pattern

device · product 10 of 15

DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028045

Z-1769-2024

Recall number: Z-1769-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 40 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 25051684011843 Lot Numbers: 5807204

Distribution pattern

device · product 11 of 15

DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055

Z-1770-2024

Recall number: Z-1770-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 260 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 25051684011850 Lot Numbers: 5809646

Distribution pattern

device · product 12 of 15

DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191

Z-1771-2024

Recall number: Z-1771-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 15 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 25051684011850 Lot Numbers: 5807208

Distribution pattern

device · product 13 of 15

DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195

Z-1772-2024

Recall number: Z-1772-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 285 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

XXX

Code information

UDI-DI: 25051684011935 Lot Numbers: 5807195, 5807196

Distribution pattern

device · product 14 of 15

DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028201

Z-1773-2024

Recall number: Z-1773-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 50 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 15051684011945 Lot Numbers: 5809464

Distribution pattern

device · product 15 of 15

BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181

Z-1774-2024

Recall number: Z-1774-2024
Initiated: March 18, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Angiodynamics, Inc.
Quantity: 250 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Code information

UDI-DI: 25051684025680 Lot Numbers: 5810278