Medivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly
Medivators is recalling Endo SmartCap Tubing kits due to a manufacturing anomaly that may cause inadequate insufflation, air bubbles, or water leaks during endoscopic procedures.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a functional defect (manufacturing anomaly) rather than a high-risk pathogen or structural failure, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Medivators, Inc. is recalling 53,790 units of Endo SmartCap Tubing kits (REF 100651) used with Olympus GI endoscopes. The recall is due to a manufacturing anomaly that may present during procedures as inadequate insufflation, the presence of air bubbles inside the tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
The affected products were distributed worldwide, including the United States, Australia, and England. The kits are intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
Healthcare facilities should stop using the affected lots and contact Medivators for further instructions. Specific lot numbers and case UDI numbers are listed in the official recall notice.
The recalled product
- Product
- Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for…
- Manufacturer
- Medivators, Inc.
- Affected units
- 53,790
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 (15)
- Lot # / Case UDI#s: 430358 / 2067796406530322060110430358
- 429884 / 2067796406530322060110429884
- 428806 / 2067796406530322070110428806
- 430568 / 2067796406530322060110430568
- 431254 / 2067796406530322070110431254
- 431455 / 2067796406530322070110431455
- 431603 / 2067796406530322070110431603
- 431834 / 2067796406530322070110431834
- 431985 / 2067796406530322070110431985
- 431973 / 2067796406530322070110431973
- 432922 / 2067796406530322070110432922
- 432108 / 2067796406530322070110432108
- 432921 / 2067796406530322070110432921
- 433116 / 2067796406530322070110433116
- 433115 / 2067796406530322080110433115.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Medivators, 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 7 products in this recall →Related recalls
Same manufacturer · Medivators, Inc.
See all →- HighDialysate Concentrate for Hemodialysis Recalled for Out-of-Specification Formulation
FDA (Devices) · 2021-06-23
- HighMedivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly
FDA (Devices) · 2020-04-29
- HighMedivators Recalls Endo Smartcap Endoscope Tubing Due to Manufacturing Anomaly
FDA (Devices) · 2020-04-29
- HighMedivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly
FDA (Devices) · 2020-04-29
- HighMedivators Recalls Endo Smartcap Endoscope Tubing Due to Manufacturing Anomaly
FDA (Devices) · 2020-04-29
Same hazard · manufacturing defect
See all →- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-23
Similar recalls
- HighERBEFLO CleverCap Endoscope Tubing Sets Recalled for Water Aspiration Risk
FDA (Devices) · 2026-05-13
- SevereERBEFLO CleverCap CO2 Tubing and Cap Sets for Endoscopes
FDA (Devices) · 2026-05-13
- SevereEndoscopy Pump Tubing/Cap Set water aspiration risk recall
FDA (Devices) · 2026-05-13
- HighOlympus Video Duodenoscope Recall Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
- ModerateOER-ELITE Endoscope Reprocessor Connecting Tubes Recalled Nationwide
FDA (Devices) · 2026-04-29
- HighOlympus Tracheal Intubation Fiberscope may lodge in endotracheal tube connector
FDA (Devices) · 2023-09-06