Aesculap JS SterilContainer S2 System Recall: FDA Clearance Issue
Aesculap recalls JS Series SterilContainer S2 Systems sold without FDA 510K clearance. These surgical containers may pose risks due to lack of regulatory approval before market release.
Recall notice
The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.
Contact the company
What happened, in plain English
Aesculap is recalling certain JS Series SterilContainer S2 Systems that were sold before receiving FDA clearance. This recall is because these products were released to the market without the required regulatory approval, which could pose safety risks during medical procedures. Read more at govinfonow.com/recall/73049-aesculap-js-sterilcontainer-s2-system-recall-fda-clearance-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/73049-aesculap-js-sterilcontainer-s2-system-recall-fda-clearance-issue · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0624-2018
Cite this page
“Aesculap JS SterilContainer S2 System Recall: FDA Clearance Issue.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73049-aesculap-js-sterilcontainer-s2-system-recall-fda-clearance-issue. Based on FDA recall #Z-0624-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0624-2018%22&limit=1).
Why it’s dangerous
The JS Series SterilContainer S2 Systems were released to the market before getting FDA 510K clearance. This means the products were not fully tested or approved for safety before being sold, which could lead to complications during medical procedures.
Who’s affected
Surgical professionals and hospitals using the recalled JS Series SterilContainer S2 Systems are most at risk. Patients undergoing surgery with these containers may face potential safety issues due to the lack of regulatory approval.
How to tell if you have this one
Check for the model numbers listed: JS440, JS441, JS442, JS444, JS489, JS740, JS741, JS742, JS789, JS340, JS341, JS342, JS389. These containers were sold without FDA clearance and are part of the recall.
- Brand
Aesculap- Category
Medical device
What to do — step by step
Check Product Model
Identify the model number on the container to confirm if it is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationally” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0624-2018 (September 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0624-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.