Pentax Recalls 9,669 Gastroscope Units Due to Lodged Accessories
Pentax Medical is recalling 9,669 gastroscope units because operational or cleaning accessories can become lodged in the instrument channel.
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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Pentax Medical Company is recalling 9,669 units of its Gastroscope products. The affected models include FG-16V, FG-24V, FG-29V, EG-1540, EG-1580K, EG1840, EG-2540, EG-2940, EG-3840T, EG-3831T, EG-3870TK, EG-1870K, EG-2470K, EG-2530, EG-2730K, EG-2731, EG-2770K, EG-290KP, EG-2930K, EG-2931, EG-2931K, EG-2970K, EG-3430Z, EG-3470K, EG-3470ZK, EG-1690K, EG-2490K, EG-2790I, EG-2790K, EG27-I10, EG-2990I, EG-2990K, EG29-I10, EG-3490K, and EG-3890TK. These devices are intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract, including the esophagus, stomach, and duodenum, for adult and pediatric patients.
The recall was initiated because Pentax became aware that operational and cleaning accessories, as well as therapeutic devices such as clips, stents, and balloons, can become lodged in the endoscope's instrument channel. The affected units were distributed nationwide in the United States, including Puerto Rico, and internationally to Denmark and Guam.
Healthcare facilities and users should contact Pentax Medical Company for further instructions on how to manage the recalled devices. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth…
- Manufacturer
- Pentax Medical Company
- Category
- Medical Device — Endoscopes
- Affected units
- 9,669
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)
- Model #'s FG-16V
- FG-24V
- FG-29V
- EG-1540
- EG-1580K
- EG1840
- EG-2540
- EG-2940
- EG-3840T
- EG-3831T
- EG-3870TK
- EG-1870K
- EG-2470K
- EG-2530
- EG-2730K
- EG-2731
- EG-2770K
- EG-290KP
- EG-2930K
- EG-2931
Distribution
Part of a larger recall action
This product is one of 16 recalled by Pentax Medical Company 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 16 products in this recall →Related recalls
Same manufacturer · Pentax Medical Company
See all →- ModeratePentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
FDA (Devices) · 2016-08-03
- ModeratePentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
FDA (Devices) · 2016-08-03
- ModeratePentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
FDA (Devices) · 2016-08-03
- ModeratePentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
FDA (Devices) · 2016-08-03
- ModeratePentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly
FDA (Devices) · 2016-08-03
Same hazard · lodged accessory
See all →- HighPentax Laryngo Stroboscope Recalled Due to Lodged Accessories Risk
FDA (Devices) · 2016-07-06
- HighPentax Choledocho-Nephroscope Recalled Due to Lodged Accessories in Instrument Channel
FDA (Devices) · 2016-07-06
- HighPentax Ultrasound Bronchoscopes Recalled for Lodged Accessories Risk
FDA (Devices) · 2016-07-06
- HighPentax Medical Recalls Bronchoscopes Due to Lodged Accessories
FDA (Devices) · 2016-07-06
- HighPentax Intubation Scope Recall Due to Lodged Accessories in Instrument Channel
FDA (Devices) · 2016-07-06
Similar recalls
- ModeratePentax Video Gastroscope Recall for Updated Operation and Reprocessing Instructions
FDA (Devices) · 2016-11-02
- HighPentax Ultrasound Gastroscopes Recalled Due to Aspiration Needle Derailment Risk
FDA (Devices) · 2014-07-30
- HighPentax Video Duodenoscope Recalled to Mitigate Infection Risk
FDA (Devices) · 2018-02-28
- ModeratePentax Ultrasound Video Gastroscope Recall Due to Instruction Error
FDA (Devices) · 2017-08-30
- ModeratePentax Ultrasound Video Gastroscope Recalled for Incorrect Disinfection Instructions
FDA (Devices) · 2017-08-30
- HighPentax Upper GI Endoscopes and Colonoscopes: Updated Reprocessing Instructions
FDA (Devices) · 2021-09-22