Ethicon Endo-Surgery Inc: Medical Device Recall in 2015 - (Recall #: Z-2374-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class I

Date Initiated: May 13, 2015

Date Posted: September 2, 2015

Recall Number: Z-2374-2015

Event ID: 71551

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.

Status: Terminated

Product Quantity: 14 units

Code Information:

Model #SEDPRU01

Distribution Pattern:

Nationwide Distribution including OH, RI, TX & WA.

Voluntary or Mandated:

Voluntary: Firm initiated