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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75055

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

Open FDA event record

Event summary

Timeline bucket
October 19, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ultroid Technologies, 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

4 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 4

Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes

Z-0782-2017
Recall number
Z-0782-2017
Initiated
October 19, 2016
Classification
Class II
Status
Terminated
Quantity
1,129

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

Code information

ALL serial numbers and lot numbers sold since 2003.

Distribution pattern

AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam

device · product 2 of 4

Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes

Z-0783-2017
Recall number
Z-0783-2017
Initiated
October 19, 2016
Classification
Class II
Status
Terminated
Quantity
62 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

Code information

ALL serial numbers and lot numbers sold since January 14, 2003.

Distribution pattern

AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam

device · product 3 of 4

Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.

Z-0784-2017
Recall number
Z-0784-2017
Initiated
October 19, 2016
Classification
Class II
Status
Terminated
Quantity
52,084

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

Code information

ALL serial numbers and lot numbers sold since January 14, 2003.

Distribution pattern

AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam

device · product 4 of 4

Ultroid Sterile Disposable Probes sold individually

Z-0785-2017
Recall number
Z-0785-2017
Initiated
October 19, 2016
Classification
Class II
Status
Terminated
Quantity
7,784

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

Code information

ALL serial numbers and lot numbers sold since January 14, 2003.

Distribution pattern

AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam