Temperature Sensing 100% Silicone Foley Catheter — Class II medical device recall Z-1781-2020
Terminated recall by Degania Medical Devices Pvt. Ltd., reported 2020-04-29, distributed nationwide. Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the spe
| Recall number | Z-1781-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Degania Medical Devices Pvt. Ltd., Gurgaon, N/A, India |
| Recall initiated | 2020-03-17 |
| Classified | 2020-04-23 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2024-10-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 700 |
| Lot numbers | S18012796 |
| Model numbers | 102201101080MD |
Product
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason for recall
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1781-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.