Olympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling 21 Olympus GIF-XP160 video gastroscopes because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.
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: The recall involves a medical device defect that could lead to improper operation (angulation failure) during a procedure, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Integrated Medical Systems Inc is recalling 21 Olympus Model No. GIF-XP160 flexible video gastroscopes. The recall is due to a defect where the internal coil pipe assembly at the distal end of the endoscope can become detached if excessive pressure is applied. This detachment may result in the angulation mechanism not operating as intended.
The affected devices were distributed nationwide in the United States and in Australia. The recall covers specific serial numbers listed in the official agency documentation.
Healthcare facilities and users should stop using the affected devices and contact Integrated Medical Systems Inc for instructions on how to proceed with the recall.
The recalled product
- Product
- Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 21
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 (20)
- Serial Numbers: 2000023
- 2110370
- 2211004
- 2210975
- 2110666
- 2110583
- 2411739
- 22109S9
- 2311220
- 2812668
- 2311177
- 2110498
- 2411568
- 2110745
- 2110711
- 2000181
- 2211040
- 2812506
- 2110504
- 2311372
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Integrated Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
Same manufacturer · Integrated Medical Systems Inc
See all →- HighOlympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
- HighOlympus CF-Q160L Video Colonoscopes Recalled for Detached Internal Coil Pipe Assembly
FDA (Devices) · 2016-03-02
- HighOlympus Video Colonoscopes Recalled Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
- HighOlympus Video Gastroscope Recall Due to Detached Internal Coil Assembly
FDA (Devices) · 2016-03-02
- HighOlympus Video Colonoscope Recall Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateOlympus Recalls Gastrovideoscope Due to Insufficient Cleaning Accessory Information
FDA (Devices) · 2015-10-07
- ModerateOlympus Ultrasound Gastrovideoscope Recalled Due to Adhesive Preparation Error
FDA (Devices) · 2019-03-20
- ModerateOlympus GIF-H180J Gastrointestinal Videoscope Recalled Due to Adhesive Error
FDA (Devices) · 2019-03-20
- HighOlympus Ultrasound Endoscope Recall for Infection Risk Reduction
FDA (Devices) · 2020-12-09
- HighEVIS EXERA III Gastrointestinal Videoscope Recalled Due to Sterilization Failures
FDA (Devices) · 2023-11-15
- HighGastrointestinal videoscopes recalled due to unvalidated channel drying process
FDA (Devices) · 2023-11-29