Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Sapphire Infusion Pumps Recalled by EITAN MEDICAL LTD Due to Infusion Pumps with affected software revision may fail...

Date: September 11, 2023
Company: EITAN MEDICAL LTD
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact EITAN MEDICAL LTD directly.

Affected Products

Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)

Quantity: 1383

Why Was This Recalled?

Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About EITAN MEDICAL LTD

EITAN MEDICAL LTD has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report