Aesculap ELAN 4 Air System Recall: Unapproved Medical Device
Aesculap recalls ELAN 4 Air System devices for spine, ENT, neuro and maxillofacial surgery that were sold without FDA clearance. This unapproved device may pose risks during surgical procedures.
Recall notice
The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).
Contact the company
What happened, in plain English
Aesculap is recalling ELAN 4 Air System devices used in spine, ENT, neuro, and maxillofacial surgery. These devices were sold without proper FDA clearance, which could lead to safety issues during medical procedures. Read more at govinfonow.com/recall/73076-aesculap-elan-4-air-system-recall-unapproved-medical-device.
Source Summary by GovInfoNow · govinfonow.com/recall/73076-aesculap-elan-4-air-system-recall-unapproved-medical-device · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0623-2018
Cite this page
“Aesculap ELAN 4 Air System Recall: Unapproved Medical Device.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73076-aesculap-elan-4-air-system-recall-unapproved-medical-device. Based on FDA recall #Z-0623-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0623-2018%22&limit=1).
Why it’s dangerous
The ELAN 4 Air System was released to the market before receiving FDA approval for medical use. This means the device may not meet safety standards required for surgical procedures, potentially causing complications during bone cutting operations.
Who’s affected
Medical professionals using ELAN 4 Air System devices for bone cutting in spine, ENT, neuro, and maxillofacial surgery are likely affected. Patients receiving these procedures may be at risk if the device is used without proper clearance.
How to tell if you have this one
Check for ELAN 4 Air System products with model numbers ST0607 through ST06411 and ST0614, ST0615, ST0638. These devices were sold in the U.S. without FDA clearance.
- Brand
Aesculap- Category
Medical device
What to do — step by step
Check Device Model
Identify your ELAN 4 Air System model number from the product list: ST0607, ST0608, ST0609, ST06411, ST0614, ST0615, or ST0638.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide Distribution.” 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-0623-2018 (September 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0623-2018 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.