Data Foundry

Medical device recalls 2021

Lase DiscectomLase Discectomy Device Kit — Class II medical device recall Z-2405-2021

Terminated recall by Clarus Medical, Llc, reported 2021-09-08. The sterile barrier seal may be compromised.

Recall numberZ-2405-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmClarus Medical, Llc, Minneapolis, MN, United States
Recall initiated2021-07-27
Classified2021-09-02
Reported by FDA2021-09-08
Terminated2022-09-15
Quantity858 units
Reason classessterility, packaging
Serial numbers64139
Model numbers1100-002

Product

Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002

Reason for recall

The sterile barrier seal may be compromised.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2405-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.