Z-2374-2015Class I

SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and...

Name: Z-2374-2015 SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and...
Creator: Ethicon Endo-Surgery Inc
Published: 2015-05-13
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2015-05-13 / Terminated / root cause: design

FDA source

Ethicon Endo-Surgery Inc began a recall of SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide... on 2015-05-13. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2374-2015
Classification: Class I
Status: Terminated
Initiated: 2015-05-13
Posted: 2015-08-26
Terminated: 2016-05-02
Recalling firm: Ethicon Endo-Surgery Inc
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.
Product code: PDR Computer-Assisted Personalized Sedation System
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.
Root cause tag: design
FDA root cause: Device Design
Action: Sedasys, a Division of Ethicon Endo-Surgery, Inc. sent an Urgent Customer Notification letter dated May 27, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1. Please distribute this information to all staff within your facility who use the SEDASYS System 2. Complete the Business Reply Form (BRF) (Attachment A) confirming receipt of this notice within three (3) business days. The BRF may be given to your sales or service representative or sent to Sedasys by email at [email protected]. 3. Keep this notice visibly posted in your facility for awareness. 4. If you have any questions or concerns regarding the condition of your SEDASYS System including the Control Units, please contact your Sales or Service Representative. If you need clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-800-SEDASYS (1-800-733-2797). If you need additional communications packages, contact 1-800-SEDASYS and reference Event 052715SED01. For questions regarding this recall call 513-337-7439.
Quantity in commerce: 14 units
Distribution: Nationwide Distribution including OH, RI, TX & WA.
Product codes and lots: Model #SEDPRU01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2374-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2374-2015	Class I	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-26

Product code PDR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)