Clarus Medical Lase Discectomy Device Kit Recall: Sterile Seal Risk
Clarus Medical recalls Lase Discectomy Device Kit models 1100-002 and 1100-002 SHORT with potential sterile barrier seal compromise. Affected units sold between specific serial numbers.
Lower-risk recall
The sterile barrier seal may be compromised.
Contact the company
What happened, in plain English
Clarus Medical is recalling two specific Lase Discectomy Device Kit models due to a possible compromise of the sterile barrier seal. This could lead to infection risks during medical procedures if the device is used without proper sterility. Read more at govinfonow.com/recall/62143-clarus-medical-lase-discectomy-device-kit-recall-sterile-seal-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62143-clarus-medical-lase-discectomy-device-kit-recall-sterile-seal-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2405-2021
Cite this page
“Clarus Medical Lase Discectomy Device Kit Recall: Sterile Seal Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62143-clarus-medical-lase-discectomy-device-kit-recall-sterile-seal-risk. Based on FDA recall #Z-2405-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2405-2021%22&limit=1).
Why it’s dangerous
The sterile barrier seal may become compromised, potentially allowing contamination during medical procedures. This could lead to infection risks if the device is used without proper sterility.
Who’s affected
Medical professionals using the recalled device kits are most at risk. Patients undergoing spinal procedures with these kits could face infection risks if the sterile seal is compromised.
How to tell if you have this one
Check for model numbers 1100-002 or 1100-002 SHORT on the device kit. Serial numbers 64139 through 65022 indicate affected units.
- Brand
Clarus Medical- Category
Medical device
What to do — step by step
Check Device Model
Verify the model number on the device kit to confirm if it is 1100-002 or 1100-002 SHORT.
Review Serial Number
Check the serial number to see if it falls within the range 64139 through 65022.
How this recall unfolded
Recall timeline
FDA terminated this recall 14 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-2405-2021 (July 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2405-2021 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.