CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter recalled
Covidien is recalling Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 5CCCC2W, distributed nationwide in the US. The recall was initiated on 30 Apr 2020 and the FDA has classified it as Class II.
Check your package
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-1985-2020
- FDA event ID
- 85629
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2020
- FDA classified
- 14 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Heart & Vascular Devices
Timeline
| 30 Apr 2020 | Recall initiated by company | |
| 14 May 2020 | Classified by FDA | +14 days |
| 20 May 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
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 5CCCC2W recalled?
Yes. Covidien recalled Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 5CCCC2W on 30 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-1985-2020.
Why was it recalled?
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Which lots are affected?
Lot Number: 1909500464
Where was it sold?
US Nationwide distribution.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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