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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Boston Scientific Corporation: Sterility of device is compromised due to a sterile barrier breach

Agency Publication Date: March 11, 2022
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Affected Products

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

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

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

Lot Numbers: 27625066 27805561 GTIN: 8714729778295

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

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

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

Lot Numbers: 27802363 GTIN: 8714729778240

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

Lot Numbers: 27566790 27641143 27852432 GTIN: 8714729778233

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

Lot Numbers: 27692922 GTIN: 8714729778257

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

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

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

Lot Numbers: Batch 27442309 28020415 GTIN: 8714729755210

Lot Numbers:
Numbers
27442309
Product: HYDRATOME RX 44-30MM/260CM Material Number: M00583050

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

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

Lot Numbers: Batch 27556713 27684748 27949033 GTIN: 8714729755227

Lot Numbers:
Numbers
27556713
Product: HYDRATOME RX 49-20MM/260CM Material Number: M00583000

Lot Numbers: 27852433 28028722 GTIN: 8714729755159

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

Lot Numbers: 27641142 28045346 GTIN: 8714729755166

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

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

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

Lot Numbers: 27482864 GTIN: 8714729953241

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

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

Lot Numbers:
Numbers
27482863
Product: JAGTOME RX 39-20-260-025 Material Number: M00573080

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

Lot Numbers:
Numbers
Product: JAGTOME RX 39-20-450-025 Material Number: M00573090

Lot Numbers: Batch 27632862 27855805 GTIN: 8714729776550

Lot Numbers:
Numbers
27632862
Product: JAGTOME RX 39-30-260-025 Material Number: M00573100

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

Lot Numbers:
Numbers
Product: JAGTOME RX 39-30-260-025 Material Number: M00573100

Lot Numbers: 27857328 GTIN: 8714729776529

Lot Numbers:
Numbers
Product: JAGTOME RX 39-30-450-025 Material Number: M00573110

Lot Numbers: 27857328 GTIN: 8714729776529

Lot Numbers:
Numbers
Product: JAGTOME RX 44-20-260-035 Material Number: M00573040

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

Lot Numbers:
Numbers
Product: JAGTOME RX 44-20-450-035 Material Number: M00573050

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

Lot Numbers:
Numbers
Product: JAGTOME RX 44-30-260-035 Material Number: M00573060

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

Lot Numbers:
Numbers
27522394
Product: JAGTOME RX 44-30-450-035 Material Number: M00573070

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

Lot Numbers:
Numbers
27737251
Product: JAGTOME RX 49-20-260-035 Material Number: M00573000

Lot Numbers: 27690967 27949032 27604634 27692921 GTIN: 8714729121169

Lot Numbers:
Numbers
Product: JAGTOME RX 49-30-260-035 Material Number: M00573020

Lot Numbers: 27571949 GTIN: 8714729776734

Lot Numbers:
Numbers
Product: JAGTOME RX 49-30-450-035 Material Number: M00573030

Lot Numbers: 27951184 GTIN: 8714729776741

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

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

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

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

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

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.

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

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

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89468
Status: Active
Manufacturer: Boston Scientific Corporation
Manufactured In: United States
Units Affected: 29 products (21309 units; 1811 units; 12067 units; 142 units; 982 units; 15 units; 472 units; 32 units; 7695 units; 254 units; 3371 units; 251 units; 112 units; 7115 units; 68 units; 3330 units; 4487 units; 367 units; 1447 units; 98 units; 98 units; 3578 units; 3578 units; 2209 units; 163 units; 101 units; 96 units; 14 units; 500 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.