Data Foundry

Medical device recalls 2015

Femto LDV Z-Generation Femtosecond Surgical Lasers are used to… — Class II medical device recall Z-0988-2015

Terminated recall by Ziemer Usa Inc, reported 2015-01-21, distributed nationwide. The devices were not shipped with the Starter Kits.

Recall numberZ-0988-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZiemer Usa Inc, Alton, IL, United States
Recall initiated2014-12-18
Classified2015-01-15
Reported by FDA2015-01-21
Terminated2018-02-20
DistributedNationwide (US)
Quantity26 lasers
Serial numbersFLM1230, FLM1239, FLM1409, FLM1467, FLM1680, FLM1776, FLM2003, FLM2136, FLM2179, FLM2906, FLM2915, FLM3134, FLM3229, FLM3281, FLM3319, FLM3324, FLM3361, FLM3685, FLM3913, FLM4094, FLM4135, FLM4184, FLM4545, FLM4587, FLM4905 and 1 more

Product

Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.

Reason for recall

The devices were not shipped with the Starter Kits.

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-0988-2015. 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.