Boston Scientific HYDRATOME RX 44-20MM/450CM: Sterile Barrier Breach Risk
Boston Scientific recalls HYDRATOME RX 44-20MM/450CM surgical devices with a sterile barrier breach. This compromises sterility and may lead to infections during procedures. Affected units have specific lot numbers and material codes.
Lower-risk recall
Sterility of device is compromised due to a sterile barrier breach
Contact the company
What happened, in plain English
Boston Scientific is recalling HYDRATOME RX 44-20MM/450CM surgical devices because a sterile barrier breach risks infection. This is serious for medical procedures where sterility is critical. Read more at govinfonow.com/recall/61370-boston-scientific-hydratome-rx-44-20mm-450cm-sterile-barrier-breach.
Source Summary by GovInfoNow · govinfonow.com/recall/61370-boston-scientific-hydratome-rx-44-20mm-450cm-sterile-barrier-breach · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0760-2022
Cite this page
“Boston Scientific HYDRATOME RX 44-20MM/450CM: Sterile Barrier Breach Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61370-boston-scientific-hydratome-rx-44-20mm-450cm-sterile-barrier-breach. Based on FDA recall #Z-0760-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0760-2022%22&limit=1).
Why it’s dangerous
The sterile barrier breach means the device may not be sterile when used. This can lead to infections during medical procedures if the device is used without proper sterilization.
Who’s affected
Surgical professionals and hospitals using the HYDRATOME RX 44-20MM/450CM devices with the specified lot numbers and material code. Patients undergoing procedures with these devices are at risk of infection.
How to tell if you have this one
Check for the material number M00583060 and lot numbers Batch 27442309 or 28020415 on the device. The GTIN 8714729755210 is also associated with these units.
- Brand
Boston Scientific- Product
HYDRATOME RX 44-20MM/450CM Material Number: M00583060- Category
Medical device
All 31 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0751-2022 | 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 | 21309 units |
| Z-0752-2022 | 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 | 1811 units |
| Z-0753-2022 | 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 | 12067 units |
| Z-0754-2022 | DREAMTOME 44-30MM/450CM Material Number: M00584070; Lot Numbers: 27625066 27805561 GTIN: 8714729778295 | 142 units |
| Z-0755-2022 | DREAMTOME 49-20MM/260CM Material Number: M00584000; Lot Numbers: 27566791 27604633 27690970 27802364 27951185 28028721 GTIN: 8714729778226 | 982 units |
| Z-0756-2022 | DREAMTOME 49-20MM/450CM Material Number: M00584020; Lot Numbers: 27802363 GTIN: 8714729778240 | 15 units |
| Z-0757-2022 | DREAMTOME 49-30MM/260CM Material Number: M00584010; Lot Numbers: 27566790 27641143 27852432 GTIN: 8714729778233 | 472 units |
| Z-0758-2022 | DREAMTOME 49-30MM/450CM Material Number: M00584030; Lot Numbers: 27692922 GTIN: 8714729778257 | 32 units |
| Z-0759-2022 | 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 | 7695 units |
| Z-0760-2022 | HYDRATOME RX 44-20MM/450CM Material Number: M00583060; Lot Numbers: Batch 27442309 28020415 GTIN: 8714729755210 | 254 units |
| Z-0761-2022 | HYDRATOME RX 44-30MM/260CM Material Number: M00583050; Lot Numbers: 27503545 27539248 27622371 27830206 27836999 27892995 27940790 GTIN: 8714729755203 | 3371 units |
| Z-0762-2022 | HYDRATOME RX 44-30MM/450CM Material Number: M00583070; Lot Numbers: Batch 27556713 27684748 27949033 GTIN: 8714729755227 | 251 units |
| Z-0763-2022 | HYDRATOME RX 49-20MM/260CM Material Number: M00583000; Lot Numbers: 27852433 28028722 GTIN: 8714729755159 | 112 units |
| Z-0764-2022 | HYDRATOME RX 49-30MM/260CM Material Number: M00583010; Lot Numbers: 27641142 28045346 GTIN: 8714729755166 | N/A |
| Z-0765-2022 | 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 | 7115 units |
| Z-0766-2022 | JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250; Lot Numbers: 27482864 GTIN: 8714729953241 | 68 units |
| Z-0767-2022 | 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 | 3330 units |
| Z-0768-2022 | JAGTOME RX 39-20-260-025 Material Number: M00573080; Lot Numbers: 27505913 27563424 27629942 27731957 27755861 27839657 27846391 27986551 27991931 28036372 GTIN: 8714729776642 | 4487 units |
| Z-0769-2022 | JAGTOME RX 39-20-450-025 Material Number: M00573090; Lot Numbers: Batch 27632862 27855805 GTIN: 8714729776550 | 367 units |
| Z-0770-2022 | JAGTOME RX 39-30-260-025 Material Number: M00573100; Lot Numbers: 27465196 27566099 27603464 27641141 27731956 27855806 27998506 28297081 GTIN: 8714729776536 | 1447 units |
| Z-0771-2022 | JAGTOME RX 39-30-260-025 Material Number: M00573100; Lot Numbers: 27857328 GTIN: 8714729776529 | 98 units |
| Z-0772-2022 | JAGTOME RX 39-30-450-025 Material Number: M00573110; Lot Numbers: 27857328 GTIN: 8714729776529 | 98 units |
| Z-0773-2022 | 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 | 3578 units |
| Z-0774-2022 | JAGTOME RX 44-20-450-035 Material Number: M00573050; Lot Numbers: 27535120 27643043 27730949 27836207 27571950 27591704 27625065 27773387 GTIN: 8714729776666 | 3578 units |
| Z-0775-2022 | 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 | 2209 units |
| Z-0776-2022 | JAGTOME RX 44-30-450-035 Material Number: M00573070; Lot Numbers: Batch 27737251 27970819 28289451 27821545 28019275 GTIN: 8714729776543 | 163 units |
| Z-0777-2022 | JAGTOME RX 49-20-260-035 Material Number: M00573000; Lot Numbers: 27690967 27949032 27604634 27692921 GTIN: 8714729121169 | 101 units |
| Z-0778-2022 | JAGTOME RX 49-30-260-035 Material Number: M00573020; Lot Numbers: 27571949 GTIN: 8714729776734 | 96 units |
| Z-0779-2022 | JAGTOME RX 49-30-450-035 Material Number: M00573030; Lot Numbers: 27951184 GTIN: 8714729776741 | 14 units |
| Z-0780-2022 | 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. | 500 units |
| Z-0781-2022 | 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 | N/A |
What to do — step by step
Check Device Details
Verify the material number M00583060 and lot numbers Batch 27442309 or 28020415 on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0760-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0760-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.