CLASS I Device recall · Reported 2 Sep 2015 · FDA Enforcement Report
Sedasys Computer-Assisted Personalized Sedation System, SEDPRU01 recalled
Ethicon Endo-Surgery is recalling Sedasys Computer-Assisted Personalized Sedation System, SEDPRU01, distributed nationwide in the US. The recall was initiated on 13 May 2015 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2374-2015
- FDA event ID
- 71551
- Recalling firm
- Ethicon Endo-Surgery, Blue Ash, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 May 2015
- FDA classified
- 26 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Patient Monitors
Timeline
| 13 May 2015 | Recall initiated by company | |
| 26 Aug 2015 | Classified by FDA | +105 days |
| 2 Sep 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including OH, RI, TX & WA.
Questions about this recall
Is Sedasys Computer-Assisted Personalized Sedation System, SEDPRU01 recalled?
Yes. Ethicon Endo-Surgery recalled Sedasys Computer-Assisted Personalized Sedation System, SEDPRU01 on 13 May 2015. The recall is Class I and its status is Terminated. Recall number Z-2374-2015.
Why was it recalled?
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.
Which lots are affected?
Model #SEDPRU01
Where was it sold?
Nationwide Distribution including OH, RI, TX & WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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