Browse Device Recalls
33 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 33 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 33 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 16, 2025 | Pentax Medical Video Processor; Model Number: EPK-i8020c; | During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c serie... | Class II | Pentax of America Inc |
| Jan 29, 2025 | PENTAX Medical Video Colonoscope- Intended to provide optical visualization ... | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c s... | Class II | Pentax of America Inc |
| Jan 29, 2025 | PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization... | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c s... | Class II | Pentax of America Inc |
| Jan 29, 2025 | Pentax Medical Video Processor- Intended to be used with PENTAX Medical endos... | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c s... | Class II | Pentax of America Inc |
| Jul 14, 2021 | Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrum... | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (E... | Class II | Pentax of America Inc |
| Jul 14, 2021 | Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-27... | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (E... | Class II | Pentax of America Inc |
| Apr 21, 2021 | Pentax Medical Video Duodenoscope - Product Usage: intended to be used with e... | IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duo... | Class II | Pentax of America Inc |
| Sep 22, 2020 | 9310HD Digital Video Capture Module with software version 3.4.0 or higher con... | There is an intermittent software issue that could affect the systems, in which an exam video for... | Class II | Pentax of America Inc |
| Sep 22, 2020 | 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), | There is an intermittent software issue that could affect the systems, in which an exam video for... | Class II | Pentax of America Inc |
| Jan 3, 2020 | Pentax Video Colonoscope Model: EC34-i10L | Distributed in the USA without an approved 510K | Class II | Pentax of America Inc |
| Jan 3, 2020 | Pentax Video Colonoscope Model: EC38-i10L | Distributed in the USA without an approved 510K | Class II | Pentax of America Inc |
| Dec 3, 2018 | Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Ste... | Incorrect default dose and dose increments may be transmitted to the controller if the catheter R... | Class II | PENTAX of America Inc |
| Dec 3, 2018 | Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX... | Incorrect default dose and dose increments may be transmitted to the controller if the catheter R... | Class II | PENTAX of America Inc |
| Dec 3, 2018 | C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 ... | The Controller does not detect overpressure in the balloon during the application of non-dosing p... | Class II | PENTAX of America Inc |
| Dec 3, 2018 | Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile... | Incorrect default dose and dose increments may be transmitted to the controller if the catheter R... | Class II | PENTAX of America Inc |
| Mar 30, 2018 | C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System i... | The catheter alignment arrow printed onto the strain relief is not aligned with the detachment fe... | Class II | PENTAX of America Inc |
| Feb 13, 2018 | Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 049... | The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-ri... | Class II | Pentax of America Inc |
| Jul 13, 2017 | Video Cystoscope models ECY-1570 and ECY-1570K | The video cytoscopes lack 510(k) premarket notification clearance. | Class II | Pentax of America Inc |
| May 23, 2017 | Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to... | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and E... | Class II | Pentax of America Inc |
| May 23, 2017 | Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended t... | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and E... | Class II | Pentax of America Inc |
| Apr 13, 2017 | 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used t... | Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... | Class II | Pentax of America Inc |
| Apr 13, 2017 | 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7... | Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... | Class II | Pentax of America Inc |
| Apr 13, 2017 | 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to el... | Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... | Class II | Pentax of America Inc |
| Apr 13, 2017 | 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronicall... | Pentax Medical did not always provide transformers with 9175 isolation transformers are used with... | Class II | Pentax of America Inc |
| Jan 17, 2017 | Video Duodenoscope These instruments are intended to provide optical visua... | Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope t... | Class II | Pentax of America Inc |
| Dec 12, 2016 | Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9... | Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngost... | Class II | Pentax of America Inc |
| Aug 15, 2016 | Pentax Video Colonoscope is intended to be used with a PENTAX video processor... | Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that... | Class II | Pentax of America Inc |
| Aug 15, 2016 | Pentax Video Gastroscope is intended to be used with a Pentax video processor... | PENTAX Medical is initiating this field action to provide customers that have purchased the affec... | Class II | Pentax of America Inc |
| May 31, 2016 | Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor... | Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and R... | Class II | Pentax of America Inc |
| May 31, 2016 | Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope,... | The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and... | Class II | Pentax of America Inc |
| Jan 11, 2011 | Video Naso pharyngo Laryngoscopes | This field action serves to retrospectively document the actions that were taken by Pentax to co... | Class II | Pentax of America Inc |
| Jan 11, 2011 | Video Bronchoscope | This field action serves to retrospectively document the actions that were taken by Pentax to co... | Class II | Pentax of America Inc |
| Jan 11, 2011 | Video Cytoscopes | This field action serves to retrospectively document the actions that were taken by Pentax to co... | Class II | Pentax of America Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.