The Recall Desk
HighFDA (Devices)·Z-0434-2026·Announced 2025-11-19

[pending] CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FC

Pending LLM rewrite. Source: FDA_DEVICE Z-0434-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.

The recalled product

Product
CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM
Manufacturer
Cerenovus Inc
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • FCX100253/10886704083979
  • FCX100305/10886704083962
  • FCX100356/10886704083993
  • FCX100407/10886704084013
  • FCX100412/10886704084006
  • FCX100509/10886704084037
  • FCX100517/10886704084020
  • FCX100611/10886704084044
  • FCX100626/10886704084051
  • FCX100713/10886704084068
  • FCX100730/10886704084075
  • FCX100816/10886704084082
  • FCX100829/10886704084099
  • FCX140225/10886704084167
  • FCX140303/10886704084174
  • FCX140304/10886704084181
  • FCX140306/10886704084198
  • FCX140406/10886704084211
  • FCX140408/10886704084228
  • FCX140445/10886704084204

Distribution

Distributed nationwide across the United States.

Related recalls

Same category