Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 26, 2018
Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY 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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Degania Silicone, Ltd. recalled Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Pro… - a moderate-severity action.
Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Pro… was recalled by Degania Silicone, Ltd. in September 26, 2018. Reason: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body te…. Check the official notice for the remedy. Verify recall #Z-2765-2018 with the FDA Devices before acting.
The recall
Degania Silicone, Ltd. issued this moderate-severity FDA Devices recall-The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body te….
- Moderate
- severity level
- 89K units
- affected scope
- Class II
- classification
- September 26, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2765-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2765-2018) was formally reported on September 26, 2018, with the manufacturer initiating the action on June 21, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Degania Silicone, Ltd. is listed as the recalling firm, operating out of Dganya Bet, N/A. Federal records list the affected scope as 89122.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
89122
Related Recalls
6
0 from same agency
Product description
Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2765-2018 |
| Date reported | September 26, 2018 |
| Date initiated | June 21, 2018 |
| Recalling firm | Degania Silicone, Ltd. |
| Firm location | Dganya Bet, N/A |
| Affected scope | 89122 |
| Distribution | Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2765-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY 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.. Recalled by Degania Silicone, Ltd.. Units affected: 89122.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-2765-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2765-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 26, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.