Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley… — Class II medical device recall Z-1991-2020
Terminated recall by Covidien Llc, reported 2020-05-20, distributed nationwide. Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0
| Recall number | Z-1991-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Llc, Mansfield, MA, United States |
| Recall initiated | 2020-04-30 |
| Classified | 2020-05-14 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2023-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 46,828 units |
| Lot numbers | 1828205964, 1911414164 |
Product
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
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
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-1991-2020. 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.