Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

Recall Insight

This FDA Devices action (record #Z-1786-2020) was formally reported on April 29, 2020, with the manufacturer initiating the action on March 17, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Degania Medical Devices Pvt. Ltd. is listed as the recalling firm, operating out of Gurgaon, N/A. Federal records indicate 2698 units are affected.

The documented reason for this recall is: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.