Temperature sensing catheter 16FR — Class II medical device recall Z-2785-2018
Terminated recall by Degania Silicone, Ltd., reported 2018-09-26, distributed nationwide. The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body tem
| Recall number | Z-2785-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Degania Silicone, Ltd., Dganya Bet, N/A, Israel |
| Recall initiated | 2018-06-21 |
| Classified | 2018-09-20 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2024-10-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, IL, JP, MX |
| Quantity | 1,000 |
| Model numbers | 102201101663NU |
Product
Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
Reason for recall
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
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-2785-2018. 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.