FDA recall record · openFDA

Covidien LLC

8 FDA recalls on record (2023–2026) — 8 device. 8 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Temperature probe devices lack FDA clearance. 3

Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device fro 1

Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diamet 1

Due to customer complaint regarding incorrect display box labeling. 1

Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being 1

Recalls

Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 Class II 2026-04-23 COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are int Class II 2026-04-15 HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Class II 2026-01-30 Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 Class II 2026-04-23 Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042 Class II 2026-04-23 EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only Class II 2024-04-25 Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-US Class II 2023-06-02 Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS Class II 2023-05-22

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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