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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72378

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

Open FDA event record

Event summary

Timeline bucket
October 21, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Civco Medical Instruments Co. 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

5 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 5

CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Z-0286-2016
Recall number
Z-0286-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Quantity
717 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of the product cannot be assured.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of the product cannot be assured.

Code information

M367350, M370110, M375100, M381740, M406940, M407750, M413300, M413310, M434210, M436400, M445180, M647110, M093610, M113720, M122370, M153900, M206940, M250330, M250340, M258890, M315660, M333490, M340650, M340660, M418340, M421310, M450400, M465510, M473820, M499620, M519670, M519870, M535840, M560410, M569020, M665970, M085160, M096150, M107000, M130450, M155430, M163490, M203230, M215600, M237160, M280540, M295050, M309920, M315640, M335660, M341050, M395150, M426910, M432250, M445050, M447240, M447250, M457880, M463120, M470960, M472370, M491520, M501960, M572330, M610070, M623730, M626290, M648050, M104430, M105580, M109480, M119300, M123880, M181980, M183080, M205350, M208730, M256600, M288450, M395680, M419700, M490030, M511200, M524900, M530460, M636260, M070240, M084610, M087950, M090510, M093250, M096160, M107010, M113740, M122150, M126430, M130960, M142760, M150120, M151000, M161360, M162170, M175800, M176090, M179600, M188560, M197540, M201760, M204920, M206920, M212520, M226140, M226800, M237170, M239790, M242650, M264850, M273010, M277260, M277580, M281220, M282340, M286970, M287050, M288070, M300220, M303390, M304830, M309930, M322420, M330620, M346280, M352800, M360970, M365460, M374640, M377700, M377710, M382140, M384960, M391930, M395520, M408990, M413270, M414570, M415150, M426920, M431600, M431860, M437370, M445090, M446780, M453070, M454110, M457210, M461430, M466270, M471250, M481240, M489250, M492210, M494110, M500070, M516520, M526820, M542120, M548580, M554010, M569710, M573220, M595220, M601030, M602270, M615780, M623480, M629400, M645460, M655810, M543860, M552040, M557840, M567820, M581180, M582540, M584460, M599110, and M609470

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.

device · product 2 of 5

CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Z-0287-2016
Recall number
Z-0287-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Quantity
508 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of the product cannot be assured.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of the product cannot be assured.

Code information

M099850, M102860, M109690, M116920, M121840, M145200, M167240, M177420, M183850, M187880, M197330, M198000, M214900, M223090, M243020, M259940, M275080, M299890, M307610, M323480, M324340, M336880, M371260, M388610, M418830, M468260, M505290, M508000, M595790, M610020, M614660, M619370, M328280, M347150, M354390, M359630, M385190, M397110, M402790, M444170, M473920, M477540, M492030, M499400, M507160, M513450, M525040, M541820, M643750, M030030, M086380, M091280, M102870, M111660, M123680, M126080, M137910, M140300, M145210, M157840, M161840, M167250, M171090, M183020, M189070, M196210, M211180, M212890, M223100, M231440, M237620, M248310, M264360, M281640, M299900, M305420, M307400, M317480, M317770, M330280, M349060, M371270, M375160, M382480, M387010, M401610, M409400, M424530, M450070, M458240, M473700, M503560, M505300, M527200, M538410, M577750, M595800, M601380, M610780, M619380, M645840, M328290, M333440, M333900, M351980, M357390, M357430, M363450, M402800, M435210, M440470, M444240, M445560, M455870, M458780, M465230, M488220, M495560, M505790, M507610, M511470, M527370, M530970, M549930, M568660, M598380, M605200, M609520, M610190, M612150, M626760, M113980, M122090, M124190, M153630, M155540, M165430, M168960, M169740, M175890, M186700, M193520, M231410, M239510, M246180, M257780, M266760, M312790, M362170, M395860, M396870, M410330, M452260, M481510, M492020, M494620, M502320, M572970, M593290, M602160, M657490, M660000, M101260, M104980, M133950, M138380, M143100, M169200, M171950, M187800, M197320, M215100, M240270, M272370, M282240, M284870, M297910, M302490, M302680, M315550, M334520, M351870, M382620, M384290, M439310, M440000, M448600, M456880, M491590, M497000, M502440, M623240, M626430, M663670, M998920, M030040, M105680, M113440, M152150, M152940, M169210, M170230, M171840, M272150, M281840, M281950, M300120, M310780, M314090, M327470, M330010, M345300, M374880, M376770, M382630, M384280, M395870, M401010, M404110, M450390, M480400, M481490, M491580, M494340, M502340, M504250, M576110, M594750, M623230, M636250, M643670, M654360, M659160, M481500, M492040, M593520, M424160, and M472500

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.

device · product 3 of 5

CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-106(CMI), 667-127, 672-001, 698-007, 698-009, 698-013, 698-015, 742-397-T, 742-416, and H48392LT. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Z-0288-2016
Recall number
Z-0288-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Quantity
1139 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of the product cannot be assured.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of the product cannot be assured.

Code information

M475840, M475850, M483080, M184760, M201120, M201220, M201230, M229890, M230450, M248410, M265470, M282270, M307490, M322230, M367370, M370090, M381360, M421260, M431550, M452150, M458370, M488300, M514070, M572510, M576810, M606320, M626250, M639290, M642350, M648020, M540640, M543800, M551990, M592190, M604120, M448100, M477600, M477700, M504340, M504350, M507520, M524270, M544100, M569330, M569340, M590710, M600460, M632390, M643140, M604180, M091360, M109060, M122250, M186540, M202260, M253050, M275630, M308820, M335740, M425050, M457560, M483250, M499390, M547370, M559550, M118570, M206960, M425030, M430820, M085360, M089740, M099100, M107610, M118700, M137600, M201810, M220800, M231940, M353380, M358810, M394960, M425020, M430810, M448670, M476410, M488580, M497660, M547740, M598410, M632210, M633570, M085370, M118680, M155510, M173420, M187860, M205340, M353390, M358170, M358580, M358590, M391700, M391710, M395610, M430800, M451470, M616810, M654380, M118610, M451460, M118650, M139440, M141830, M225010, M338400, M435250, M448680, M463740, M499630, M623350, M119380, M206950, M358560, M358570, M381520, M427660, M440600, M526290, M526300, M118660, M141820, M190870, M272570, M435240, M491500, M508640, M622060, M106080, M118600, M124610, M148440, M268900, M283940, M317630, M358610, M381510, M391680, M484430, M484440, M492320, M526260, M526270, M118710, M148450, M490000, M593130, M162020, M205920, M317680, M210700, M262520, M297390, M317690, M334110, M347120, M369110, M373250, M379350, M385180, M390160, M450210, M500620, M539310, M541330, M541830, M448110, M448120, M460670, M472720, M524230, M534750, M536730, M557450, M566960, M593280, M598060, M627710, M552010, M455790, M480870, M510000, M541140, M541810, M576640, M600450, M609740, M610550, M636940, M643130, M650780, M085390, M120660, M177390, M295660, M352830, M355940, M395670, M408960, M430430, M463720, M530670, M568980, M609970, M620480, M663970, M056500, M096880, M112390, M119730, M232970, M251160, M261840, M304420, M374360, M419670, M440460, M475460, M497670, M545750, M603800, M085550, M089260, M093020, M103030, M105150, M183050, M220960, M293580, M293590, M388690, M419650, M560740, M056760, M103040, M124110, M183060, M234590, M312170, M436670, M436680, M444740, M598550, M639430, M093010, M119280, M120400, M120860, M142690, M158480, M220970, M237740, M242000, M261770, M388700, M407620, M419660, M444950, M598860, M328300, M330340, M345110, M349600, M381530, M464980, M547940, M598070, M624410, M117130, M139400, M142090, M164840, M186690, M190180, M193400, M201660, M205110, M232930, M234630, M275650, M297260, M322700, M327850, M335060, M368160, M423720, M430440, M435750, M456910, M475140, M477930, M504290, M528270, M570840, M576930, M639440, M088430, M089650, M091400, M095990, M102210, M116290, M119930, M124320, M133350, M134540, M135520, M139740, M144670, M163200, M163260, M171240, M179410, M187920, M192750, M202990, M213370, M217330, M223270, M229780, M231960, M245390, M253360, M280960, M299320, M346870, M382670, M394080, M394090, M397380, M423700, M437090, M476650, M542430, M544290, M573360, and M618690

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.

device · product 4 of 5

CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Z-0289-2016
Recall number
Z-0289-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Quantity
206 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of the product cannot be assured.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of the product cannot be assured.

Code information

M093630, M093640, M093650, M128890, M128930, M163120, M191470, M191880, M202970, M205490, M211000, M218540, M218550, M218560, M240080, M250210, M262470, M308100, M328800, M333890, M371670, M384130, M396710, M399210, M399320, M399340, M403640, M412450, M421190, M423310, M424480, M451230, M457640, M461290, M468590, M470900, M473810, M487020, M511040, M545900, M545910, M547320, M560870, M570280, M570290, M585600, M585610, M586670, M594480, M600470, M609760, M611000, M632640, and M643150

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.

device · product 5 of 5

CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

Z-0290-2016
Recall number
Z-0290-2016
Initiated
October 21, 2015
Classification
Class II
Status
Terminated
Quantity
54 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of the product cannot be assured.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of the product cannot be assured.

Code information

M116270, M119900, M121920, M125640, M130290, M170900, M185950, M204790, M211280, M215550, M235410, M240880, M252870, M303130, M320620, M320660, M346050, M368820, M379870, M391260, M395270, M418200, M476020, M497220, M508200, M594740, M598320, and M624430

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO RICO, QATAR, SOUTH AFRICA, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, SWITZERLAND, TRINIDAD AND TOBAGO, TURKEY, UGANDA, UKRAINE, and UNITED KINGDOM.