Olympus Video Duodenoscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling 16 Olympus TJF-160F video duodenoscopes because excessive pressure can cause the internal coil pipe 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 with a mechanical defect that could prevent intended operation, representing a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
Integrated Medical Systems Inc is recalling 16 units of the Olympus Model No. TJF-160F flexible scope, large diameter, video duodenoscope. The recall involves specific serial numbers listed in the agency documentation.
The recall is being issued because if excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end can become detached. This failure may result in the angulation mechanism not operating as intended.
The affected instruments were distributed nationwide in the United States and in Australia. Healthcare providers and facilities should identify these specific serial numbers and stop using the affected devices.
The recalled product
- Product
- Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 16
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 (16)
- Serial Numbers: 2201503
- 2000062
- 2000105
- 2100621
- 2301997
- 2100999
- 2201555
- 2302025
- 2000061
- 2201491
- 2000039
- 2100930
- 2402518
- 2302084
- 2100852
- 2101121
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
- HighOlympus Recalls TJF-Q190V Duodenoscopes Due to Reported Mucosal Injury
FDA (Devices) · 2021-03-31
- ModerateOlympus JF-160F Duodenoscopes Recalled for New Reprocessing Procedures
FDA (Devices) · 2018-06-27
- ModerateOlympus TJF-Q180V Duodenoscope Recall for Forceps Elevator Mechanism Replacement
FDA (Devices) · 2016-02-10
- SevereOlympus JF-140F Duodenoscopes Recalled for New Reprocessing Procedures
FDA (Devices) · 2018-06-27
- ModerateOlympus Recalls Duodenoscopes for New Reprocessing Instructions
FDA (Devices) · 2016-06-08
- ModerateOlympus TJF-Q180V Duodenoscope Recalled Due to Adhesive Preparation Error
FDA (Devices) · 2019-03-20