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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81968

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

Open FDA event record

Event summary

Timeline bucket
December 18, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Angiotech (Manan Medical Products, 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

7 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 7

"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Z-0814-2019
Recall number
Z-0814-2019
Initiated
December 18, 2018
Classification
Class II
Status
Terminated
Quantity
9,900 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

Code information

Model Number IMKBMN-11R-10-X, Lot Numbers LJUE, LEAC, LFKX; Model Number IMKBMN-11R-10, Lot Numbers LK0J, LEHU

Distribution pattern

Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.

device · product 2 of 7

J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Z-0815-2019
Recall number
Z-0815-2019
Initiated
December 18, 2018
Classification
Class II
Status
Terminated
Quantity
1,260 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

Code information

Model Number IMKBMN-13R-10, Lot Numbers LF69, LFDA, LFL1

Distribution pattern

Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.

device · product 3 of 7

J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Z-0816-2019
Recall number
Z-0816-2019
Initiated
December 18, 2018
Classification
Class II
Status
Terminated
Quantity
180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

Code information

Model Number IMKBMN-13R-6, Lot Number LFD9

Distribution pattern

Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.

device · product 4 of 7

Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm

Z-0817-2019
Recall number
Z-0817-2019
Initiated
December 18, 2018
Classification
Class II
Status
Terminated
Quantity
500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

Code information

Model Number BMNJ-MEC-1110, Lot Number LHT1

Distribution pattern

Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.

device · product 5 of 7

Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Z-0818-2019
Recall number
Z-0818-2019
Initiated
December 18, 2018
Classification
Class II
Status
Terminated
Quantity
1,404 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

Code information

Model Number UCIN-16-5, Lot Number LK2L

Distribution pattern

Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.

device · product 6 of 7

Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm

Z-0819-2019
Recall number
Z-0819-2019
Initiated
December 18, 2018
Classification
Class II
Status
Terminated
Quantity
2,502 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

Code information

Model Number UCIN-11-10, Lot Number LFDB

Distribution pattern

Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.

device · product 7 of 7

Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.

Z-0820-2019
Recall number
Z-0820-2019
Initiated
December 18, 2018
Classification
Class II
Status
Terminated
Quantity
504 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

Code information

Model Number UCIN-15-5, Lot Number LJ2T

Distribution pattern

Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.