Olympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing
Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II removal of an approved high-level disinfection method for an internal gastrointestinal endoscope. No reported illnesses or injuries, but inadequate sterilization of internal devices poses infection risk. Fits rubric criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas has removed high-level disinfection (HLD) with Acecide-C disinfectant from the approved reprocessing methods for the EVIS EXERA III Gastrointestinal Videoscope (Model GIF-1TH190). The Instructions for Use for the Olympus OER-Pro Automated Endoscope Reprocessor has been updated to reflect this change.
Approximately 1,770 units of the GIF-1TH190 have been distributed nationwide across all U.S. states, with serial numbers before 2446103 or after 2500453 identified as affected.
Acecide-C HLD is no longer an approved method for reprocessing these endoscopes. Facilities and healthcare providers should consult the updated Instructions for Use for the Olympus OER-Pro Automated Endoscope Reprocessor to identify approved reprocessing methods.
The recalled product
- Product
- EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,770
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Number: GIF-1TH190
- UDI: 04953170343360
- 04953170437014
- Serial Number Range: Before 2446103 or After 2500453
Distribution
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