SEDASYS Computer-Assisted Personalized Sedation System — Class I medical device recall Z-2374-2015

Terminated recall by Ethicon Endo-Surgery Inc, reported 2015-09-02, distributed nationwide. Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the de

Recall number	`Z-2374-2015`
Product type	Medical device
Classification	Class I
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Ethicon Endo-Surgery Inc, Blue Ash, OH, United States
Recall initiated	2015-05-13
Classified	2015-08-26
Reported by FDA	2015-09-02
Terminated	2016-05-02
Distributed	Nationwide (US)
Quantity	14 units
Reason classes	specification failure
Model numbers	`SEDPRU01`

Product

SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.

Reason for recall

Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.

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-2374-2015. 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.