FDA Device recall Z-2374-2015
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01
- FDA Device
- Class I
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class I recall of SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01 by Ethicon Endo Surgery, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2374-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-05-13 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | US |
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
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.
Identifiers
| code_info | Model #SEDPRU01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2374-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.