CLASS II ONGOING Device recall · Reported 23 Mar 2022 · FDA Enforcement Report
Jagtome RX 39-20-260-025 Material Number: M00573080 recalled
Boston Scientific is recalling Jagtome RX 39-20-260-025 Material Number: M00573080, distributed nationwide in the US. The recall was initiated on 22 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0768-2022
- FDA event ID
- 89468
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Dec 2021
- FDA classified
- 11 Mar 2022
- Reported
- 23 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 22 Dec 2021 | Recall initiated by company | |
| 11 Mar 2022 | Classified by FDA | +79 days |
| 23 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterility of device is compromised due to a sterile barrier breach
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
JAGTOME RX 39-20-260-025 Material Number: M00573080
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Sterility of device is compromised due to a sterile barrier breach
Which lots are affected?
Lot Numbers: 27505913 27563424 27629942 27731957 27755861 27839657 27846391 27986551 27991931 28036372 GTIN: 8714729776642
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
30 other products · FDA event 89468This product is part of a recall event; the main page for the event is Hydratome RX 44-/ Material Number: M00583060 recalled.
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