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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83819

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

Open FDA event record

Event summary

Timeline bucket
September 19, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Xodus Medical 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

3 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 3

Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory

Z-0149-2020
Recall number
Z-0149-2020
Initiated
September 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Xodus Medical Inc
Quantity
464,040 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The sterile barrier of some devices may have been affected

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterile barrier of some devices may have been affected

Code information

Lot # 17NOV27 17DEC08 17DEC08A 17DEC15 17DEC15A 18JAN05 18JAN05A 18JAN19 18FEB02 18FEB02A 18FEB16 18MAR02 18MAR19 UDI: Case 20787551000539 and Each - 00787551000535 Additional lots as of 6/8/20: 18JUL27 18JUL27A 18SEP12 18MAY11 18APR09 18OCT03 18MAY01 18NOV21 18NOV21A Additional lots as of 9/9/2021: 18DEC05 19JAN16 19JAN30 19FEB13 19FEB27 19MAR14 19MAR14A 19MAR29

Distribution pattern

Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico

device · product 2 of 3

Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory

Z-0150-2020
Recall number
Z-0150-2020
Initiated
September 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Xodus Medical Inc
Quantity
460,000 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The sterile barrier of some devices may have been affected

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterile barrier of some devices may have been affected

Code information

Lot # 16DEC19 17JAN06 17FEB10 17MAR27 17OCT09 17OCT09A 17OCT23 17OCT23A 18JAN05 18JAN05A 18JAN19 18MAR02 18MAR19 18MAR19A UDI: Case 20787551000584 and Each - 00787551000580 Additional lots as of 6/8/20: 18APR09 18MAY01 18MAY11 18MAY25 18MAY25A 18MAY25B 18JUN27 18AUG14 18SEP12 18OCT03 Additional lots as of 9/9/2021: 18DEC05 18DEC26 18DEC26A 19JAN30 19JAN30A

Distribution pattern

Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico

device · product 3 of 3

Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory

Z-0151-2020
Recall number
Z-0151-2020
Initiated
September 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Xodus Medical Inc
Quantity
255,000 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The sterile barrier of some devices may have been affected

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterile barrier of some devices may have been affected

Code information

Lot # 16DEC19 17JAN06 17JAN06A 17JAN23 17FEB27 17MAR13 17MAR13A 17APR03 17APR14 17MAY24 17MAY24A 17MAY24B 17JUN27 17JUL17 17AUG01 17SEP22 17SEP22A 17OCT23 17NOV27 17NOV27A 17DEC15 18JAN19 18JAN19A 18FEB16 18MAR02 18MAR19 18MAR19A ***Updated 11/9/21*** 19MAR14 UDI: Case 20787551000577 and Each 00787551000573

Distribution pattern

Worldwide Distribution - US Nationwide in the States of : CA, ID, IL, LA, MD, NY, OH, OK, TX, VA, WI and OUS: Malaysia, Kuwait, Australia, Canada, UAE, Ireland, Korea, Saudi Arabia, Japan, Mexico