CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report

Temperature Sensing 100% Silicone Foley Catheter recalled

Degania Medical Devices is recalling Temperature Sensing 100% Silicone Foley Catheter, distributed nationwide in the US. The recall was initiated on 17 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: V18031235 V18050229 V18050230 V18050231 V18050232 V18050233 V19027860 V19028470 V19018929

Quantity recalled9137

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1787-2020
FDA event ID: 85327
Recalling firm: Degania Medical Devices, Gurgaon, N/A
Classification: Class II
Status: Terminated
Recall initiated: 17 Mar 2020
FDA classified: 23 Apr 2020
Reported: 29 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Heart & Vascular Devices

Timeline

17 Mar 2020	Recall initiated by company
23 Apr 2020	Classified by FDA	+37 days
29 Apr 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

Where it was distributed

Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.

Nationwide Illinois

Questions about this recall

Why was it recalled?

Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.

Which lots are affected?

Lot Numbers: V18031235 V18050229 V18050230 V18050231 V18050232 V18050233 V19027860 V19028470 V19018929

Where was it sold?

Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

10 other products · FDA event 85327

This product is part of a recall event; the main page for the event is Temperature Sensing 100% Silicone Foley Catheter recalled.

Reported	Class	Recall	Company	Reason	Where
29 Apr 2020	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide

More recalls from Degania Medical Devices

All 11

Reported	Class	Recall	Company	Reason	Where
29 Apr 2020Device	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020Device	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020Device	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020Device	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide
29 Apr 2020Device	CLASS II	Temperature Sensing 100% Silicone Foley Catheter recalled	Degania Medical Devices	Temperature Abuse	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide