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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85904

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

Open FDA event record

Event summary

Timeline bucket
June 08, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Sofamor Danek USA 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

6 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 6

Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

Z-2690-2020
Recall number
Z-2690-2020
Initiated
June 08, 2020
Classification
Class II
Status
Terminated
Quantity
778 pk

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

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

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Code information

Lot # BY19L007 BY19M013 BY20A014 BY20C011

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.

device · product 2 of 6

Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

Z-2691-2020
Recall number
Z-2691-2020
Initiated
June 08, 2020
Classification
Class II
Status
Terminated
Quantity
481 pk

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

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

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Code information

Lot # BY19K031 BY19L011

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.

device · product 3 of 6

Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

Z-2692-2020
Recall number
Z-2692-2020
Initiated
June 08, 2020
Classification
Class II
Status
Terminated
Quantity
2415 pk

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

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

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Code information

Lot # BY19L001 BY19L022 BY19L044 BY19M001 BY19M002 BY20A022 BY20B009

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.

device · product 4 of 6

Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

Z-2693-2020
Recall number
Z-2693-2020
Initiated
June 08, 2020
Classification
Class II
Status
Terminated
Quantity
352 pk

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

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

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Code information

Lot # BY19L009 BY20A012

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.

device · product 5 of 6

Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

Z-2694-2020
Recall number
Z-2694-2020
Initiated
June 08, 2020
Classification
Class II
Status
Terminated
Quantity
5 pk

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

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

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Code information

Lot # BY19L039

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.

device · product 6 of 6

Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

Z-2695-2020
Recall number
Z-2695-2020
Initiated
June 08, 2020
Classification
Class II
Status
Terminated
Quantity
25 pk

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

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

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Code information

Lot # BY19D020

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.