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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89468

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

Open FDA event record

Event summary

Timeline bucket
December 22, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

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

31 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 31

Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040

Z-0751-2022
Recall number
Z-0751-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
21309 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Batch Numbers: 27446479 27448337 27470857 27473288 27479007 27488955 27519099 27583248 27584920 27609359 27610230 27616517 27674795 27679150 27681372 27682823 27710650 27715915 27740170 27742966 27746783 27747640 27770749 27779090 27781488 27784284 27806906 27808089 27813903 27818805 27869283 27872956 27955178 27958586 27965294 28021413 28054973 28118052 28296777 28296779 GTIN: 8714729778264

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 2 of 31

Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060

Z-0752-2022
Recall number
Z-0752-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
1811 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27463326 27468730 27553568 27590928 27629941 27684747 27764231 27794744 27837500 27931763 27986550 28058938 GTIN: 8714729778288

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 3 of 31

DREAMTOME 44-30MM/260CM Material Number: M00584050

Z-0753-2022
Recall number
Z-0753-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
12067 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27453804 27457431 27549729 27556712 27575367 27579180 27605386 27605881 27660096 27667092 27672343 27708191 27709633 27787771 27789167 27899695 27924755 27971482 27976277 27979230 28047306 28054381 GTIN: 8714729778271

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 4 of 31

DREAMTOME 44-30MM/450CM Material Number: M00584070

Z-0754-2022
Recall number
Z-0754-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
142 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27625066 27805561 GTIN: 8714729778295

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 5 of 31

DREAMTOME 49-20MM/260CM Material Number: M00584000

Z-0755-2022
Recall number
Z-0755-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
982 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27566791 27604633 27690970 27802364 27951185 28028721 GTIN: 8714729778226

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 6 of 31

DREAMTOME 49-20MM/450CM Material Number: M00584020

Z-0756-2022
Recall number
Z-0756-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
15 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27802363 GTIN: 8714729778240

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 7 of 31

DREAMTOME 49-30MM/260CM Material Number: M00584010

Z-0757-2022
Recall number
Z-0757-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
472 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27566790 27641143 27852432 GTIN: 8714729778233

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 8 of 31

DREAMTOME 49-30MM/450CM Material Number: M00584030

Z-0758-2022
Recall number
Z-0758-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
32 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27692922 GTIN: 8714729778257

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 9 of 31

HYDRATOME RX 44-20MM/260CM Material Number: M00583040

Z-0759-2022
Recall number
Z-0759-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
7695 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27439836 27440919 27493069 27496980 27499896 27750785 27753215 27825981 27879216 27880741 27931764 27934862 28032489 28043447 GTIN: 8714729755197

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 10 of 31

HYDRATOME RX 44-20MM/450CM Material Number: M00583060

Z-0760-2022
Recall number
Z-0760-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
254 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: Batch 27442309 28020415 GTIN: 8714729755210

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 11 of 31

HYDRATOME RX 44-30MM/260CM Material Number: M00583050

Z-0761-2022
Recall number
Z-0761-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
3371 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27503545 27539248 27622371 27830206 27836999 27892995 27940790 GTIN: 8714729755203

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 12 of 31

HYDRATOME RX 44-30MM/450CM Material Number: M00583070

Z-0762-2022
Recall number
Z-0762-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
251 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: Batch 27556713 27684748 27949033 GTIN: 8714729755227

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 13 of 31

HYDRATOME RX 49-20MM/260CM Material Number: M00583000

Z-0763-2022
Recall number
Z-0763-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
112 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27852433 28028722 GTIN: 8714729755159

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 14 of 31

HYDRATOME RX 49-30MM/260CM Material Number: M00583010

Z-0764-2022
Recall number
Z-0764-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27641142 28045346 GTIN: 8714729755166

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 15 of 31

JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240

Z-0765-2022
Recall number
Z-0765-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
7115 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27481920 27524107 27525279 27530542 27574053 27598798 27652479 27722062 27722511 27742261 27758891 27795634 27846706 27897451 27969768 28027118 28070708 GTIN: 8714729953234

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 16 of 31

JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250

Z-0766-2022
Recall number
Z-0766-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
68 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27482864 GTIN: 8714729953241

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 17 of 31

JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260

Z-0767-2022
Recall number
Z-0767-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
3330 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: Batch 27482863 27532553 27602969 27652583 27723139 27758892 27796835 27846707 27899139 27966498 28021411 GTIN: 8714729953258

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 18 of 31

JAGTOME RX 39-20-260-025 Material Number: M00573080

Z-0768-2022
Recall number
Z-0768-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
4487 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27505913 27563424 27629942 27731957 27755861 27839657 27846391 27986551 27991931 28036372 GTIN: 8714729776642

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 19 of 31

JAGTOME RX 39-20-450-025 Material Number: M00573090

Z-0769-2022
Recall number
Z-0769-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
367 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: Batch 27632862 27855805 GTIN: 8714729776550

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 20 of 31

JAGTOME RX 39-30-260-025 Material Number: M00573100

Z-0770-2022
Recall number
Z-0770-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
1447 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27465196 27566099 27603464 27641141 27731956 27855806 27998506 28297081 GTIN: 8714729776536

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 21 of 31

JAGTOME RX 39-30-260-025 Material Number: M00573100

Z-0771-2022
Recall number
Z-0771-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
98 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27857328 GTIN: 8714729776529

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 22 of 31

JAGTOME RX 39-30-450-025 Material Number: M00573110

Z-0772-2022
Recall number
Z-0772-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
98 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27857328 GTIN: 8714729776529

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 23 of 31

JAGTOME RX 44-20-260-035 Material Number: M00573040

Z-0773-2022
Recall number
Z-0773-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
3578 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27465198 27515974 27595732 27625064 27720618 27737252 27765472 27833280 27883444 28002224 28296772 27491776 27595731 27618170 27718421 27758432 27764571 27830207 27858381 28002225 28289452 GTIN: 8714729776659

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 24 of 31

JAGTOME RX 44-20-450-035 Material Number: M00573050

Z-0774-2022
Recall number
Z-0774-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
3578 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

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Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27535120 27643043 27730949 27836207 27571950 27591704 27625065 27773387 GTIN: 8714729776666

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 25 of 31

JAGTOME RX 44-30-260-035 Material Number: M00573060

Z-0775-2022
Recall number
Z-0775-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
2209 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: Batch 27522394 27566792 27589267 27618168 27726335 27758466 27795807 27822419 27458135 27472063 27553565 27649356 27706277 27758465 27773622 27821544 27865086 27986549 28017367 28289453 GTIN: 8714729776673

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 26 of 31

JAGTOME RX 44-30-450-035 Material Number: M00573070

Z-0776-2022
Recall number
Z-0776-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
163 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: Batch 27737251 27970819 28289451 27821545 28019275 GTIN: 8714729776543

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 27 of 31

JAGTOME RX 49-20-260-035 Material Number: M00573000

Z-0777-2022
Recall number
Z-0777-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
101 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27690967 27949032 27604634 27692921 GTIN: 8714729121169

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 28 of 31

JAGTOME RX 49-30-260-035 Material Number: M00573020

Z-0778-2022
Recall number
Z-0778-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
96 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27571949 GTIN: 8714729776734

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 29 of 31

JAGTOME RX 49-30-450-035 Material Number: M00573030

Z-0779-2022
Recall number
Z-0779-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
14 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: 27951184 GTIN: 8714729776741

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 30 of 31

RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481

Z-0780-2022
Recall number
Z-0780-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
500 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers: M00575241 RX CHOLANGIOGRAM KIT: Lot Numbers"27879206, 28103331, 28336117 UDI: 8714729818380; M00575281 RX CHOLANGIOGRAM KIT Lot Numbers: 27803953, 27878151, 27919775 UDI: 8714729818410 M00575321 RX CHOLANGIOGRAM KIT Lot Numbers: 27955111, 28024443, 28269925 UDI: 8714729818427; M00575361 RX CHOLANGIOGRAM KIT Lot Number:28074763 UDI:8714729818458; M00575381 RX CHOLANGIOGRAM KIT Lot Numbers: 27755939, 27990502 UDI: 8714729818465; M00575401 RX CHOLANGIOGRAM KIT Lot NUmber: 28311945 UDI:8714729818472; M00575441 RX CHOLANGIOGRAM KIT Lot Numbers: 27673853, 27891176 , 28024444 UDI: 8714729818489; M00575481 RX CHOLANGIOGRAM KIT Lot Numbers: 27919776, 28060354 UDI: 8714729818496.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

device · product 31 of 31

RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480

Z-0781-2022
Recall number
Z-0781-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
compromised due to a sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device is compromised due to a sterile barrier breach

Code information

Lot Numbers/UDI: 27877022 8714729750031 28098229 8714729750031 28329450 8714729750031 27803952 8714729750079 27877021 8714729750079 27914711 8714729750079 27950226 8714729750079 28110693 8714729750079 27950225 8714729750116 28018192 8714729750116 28253295 8714729750116 28069582 8714729750154 27751896 8714729750178 27983611 8714729750178 28296770 8714729750192 27658435 8714729750239 27891175 8714729750239 28018195 8714729750239 27914712 8714729750277

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.