Facility

Eitan Medical LTD

1 recall(s) on record — most severe on record: Class I.

Key facts

1recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010293992
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	29 Yad Haruzim St. Netanya Central, IL 42505
Registration status	Active · expires 2026
Parent company	Eitan Medical LTD (owner-operator 10045422)
Brand names	Sapphire Infusion Pump

Activity by year

Recalls (1)

Devices registered here (2)

Set, Administration, Intravascular
Product code FPA (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5440
Pump, Infusion
Product code FRN (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5725

Recalls & enforcement

Class IOngoing2023-09-11
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

All facilities operated by Eitan Medical LTD

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Eitan Medical LTD (FEI 3010293992) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010293992-eitan-medical-ltd/

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