FDA recall record · openFDA

Covidien

17 FDA recalls on record (2023–2025) — 17 device. 17 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

manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel 2

Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal 2

Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulati 2

Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethy 1

IFU update to address device's battery handling information. 1

Recalls

Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R Class I 2025-02-26 Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, Class I 2025-05-21 McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only Class I 2024-07-09 Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB56 Class I 2024-06-24 McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only Class I 2024-07-09 Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Class I 2023-03-24 Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 Class I 2023-09-28 Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941 Class II 2025-06-23 Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC Class II 2024-01-09 Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 Class II 2024-02-21 Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC Class II 2024-01-09 Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly Class II 2024-07-09 McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only Class II 2023-08-10 Puritan Bennett Cuff Pressure Manager, REF: 180-03 Class II 2023-08-22 McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only Class II 2023-08-10 Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD Class II 2023-11-16 COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tu Class II 2023-02-10

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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