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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77631

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

Open FDA event record

Event summary

Timeline bucket
June 05, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
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

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

Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

Z-0526-2018
Recall number
Z-0526-2018
Initiated
June 05, 2017
Classification
Class II
Status
Terminated
Recalling firm
Angiodynamics, Inc.
Quantity
14,353 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

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

The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

Code information

Lots: 15310411, 15320416, 15340428, 15350430, 15360434, 15380439, 15400449, 15420453, 15430454, 15440459, 15460466, 15470468, 15490476, 15500480, 15520487, 16010488, 16050494, 16070499, 16080502, 16100508, 16120512, 16140517, 16150520, 16170528, 16180530, 16190535, 16210540, 16230549, 16240550, 16250556, 16260561, 16270562, 16300568, 16310572, 16320573, 16350581, 16370590, 16380592, 16390595, 16400599, 16410603, 16420604, 16440611, 16450617, 17010645, 17020649, 17030653, 17040657, 17060662, 17070666, 17090673, 17100675, 17130686*, 17130687.

Distribution pattern

Worldwide distribution - US Nationwide

device · product 2 of 6

Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

Z-0527-2018
Recall number
Z-0527-2018
Initiated
June 05, 2017
Classification
Class II
Status
Terminated
Recalling firm
Angiodynamics, Inc.
Quantity
14,353 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

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

The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

Code information

Lots: 15310414, 15320417, 15340425, 15360433, 15370437, 15380441, 15390445, 15400451, 15470470, 15480472, 16050496, 16070501, 16130515, 16160525, 16190536, 16250558, 16320574, 16330579, 16420606, 16440612, 16460620, 16480630, 16500637, 17010646, 17030654, 17040659, 17070667, 17090672.

Distribution pattern

Worldwide distribution - US Nationwide

device · product 3 of 6

Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

Z-0528-2018
Recall number
Z-0528-2018
Initiated
June 05, 2017
Classification
Class II
Status
Terminated
Recalling firm
Angiodynamics, Inc.
Quantity
14,353 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

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

The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

Code information

Lots: 15310413, 15320415, 15340429, 15350431, 15360432, 15370435, 15380440, 15390444, 15400450, 15430456, 15440460, 15460467, 15470469, 15480471, 15490477, 15500481, 15520484, 16010489, 16050495, 16070500, 16080503, 16090506, 16100509, 16120513, 16150521, 16160523, 16170529, 16190534, 16230548, 16240551, 16250557, 16270563, 16300569, 16310571, 16320575, 16330577, 16350582, 16350586, 16370591, 16390596, 16410602, 16430610, 16440613, 16450618, 16460619, 16500636, 16510644, 17020651, 17040658, 17050660, 17060663, 17070668, 17100674, 17110678, 17130685.

Distribution pattern

Worldwide distribution - US Nationwide

device · product 4 of 6

Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

Z-0529-2018
Recall number
Z-0529-2018
Initiated
June 05, 2017
Classification
Class II
Status
Terminated
Recalling firm
Angiodynamics, Inc.
Quantity
14,353 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

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

The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

Code information

Lots: 15310412, 15330419, 15340427, 15390446, 15430455, 15440461, 15450463, 15480473, 15490478, 16030490, 16060498, 16130514, 16160524, 16180531, 16240552, 16260560, 16330578, 16350585, 16380593, 16400600, 16420605, 16430609, 16440614, 16460621, 16500638, 16510642, 17010647, 17020650, 17030655, 17050661, 17060664, 17080669, 17110676.

Distribution pattern

Worldwide distribution - US Nationwide

device · product 5 of 6

Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

Z-0530-2018
Recall number
Z-0530-2018
Initiated
June 05, 2017
Classification
Class II
Status
Terminated
Recalling firm
Angiodynamics, Inc.
Quantity
14,353 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

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

The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

Code information

Lots: 15330421, 15340426, 15370438, 15390447, 15400452, 15430458, 15440462, 15450465, 15480475, 15500482, 15520486, 16060497, 16100507, 16130516, 16140519, 16160526, 16180532, 16190537, 16240553, 16330580, 16350583, 16380594, 16410601, 16420607, 16430608, 16440616, 16460623, 16480629, 16500639, 17020652, 17090671, 17140694.

Distribution pattern

Worldwide distribution - US Nationwide

device · product 6 of 6

Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

Z-0531-2018
Recall number
Z-0531-2018
Initiated
June 05, 2017
Classification
Class II
Status
Terminated
Recalling firm
Angiodynamics, Inc.
Quantity
14,353 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

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

The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

Code information

Lots: 15330420, 15370436, 15390448, 15430457, 15450464, 15480474, 15490479, 15520485, 16030491, 16140518, 16160527, 16180533, 16300570, 16320576, 16350584, 16440615, 16460622, 16480628, 16500640, 16510643, 17010648, 17030656.

Distribution pattern

Worldwide distribution - US Nationwide