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Covidien FDA Recalls
18 recalls on file across devices, 7 of them Class I and 18 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941Class IIJun 23, 2025Bedside SpO2 Patient Monitoring System alarms not heard/reco |
| 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 IMay 21, 2025Ventilator Printed Circuit Board Assembly may have two separ |
| Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80RClass IFeb 26, 2025Tracheostomy tube with cuff reusable inner cannula has a fla |
| Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnlyClass IIJul 9, 2024IFU update to address device's battery handling information. |
| McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx OnlyClass IJul 9, 2024Battery management system within Laryngoscope devices may de |
| McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx OnlyClass IJul 9, 2024Battery management system within Laryngoscope devices may de |
| Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB56Class IJun 24, 2024Any single affected ventilator should only be used for the 1 |
| Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1Class IIFeb 21, 2024Packs including 5 laparotomy sponges may contain incorrect p |
| Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSCClass IIJan 9, 2024manufacturing defects to sensor cable connectors may result |
| Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RICClass IIJan 9, 2024manufacturing defects to sensor cable connectors may result |
| Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZDClass IINov 16, 2023Due to software issue, New systems may exhibit an error whic |
| Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000Class ISep 28, 2023Defective video laryngoscopes that did not pass quality test |
| Puritan Bennett Cuff Pressure Manager, REF: 180-03Class IIAug 22, 2023Inadequate internal fixation of the power inlet port to the |
| McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx OnlyClass IIAug 10, 2023Laryngoscope blades may contain an ineffective application o |
| McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx OnlyClass IIAug 10, 2023Laryngoscope blades may contain an ineffective application o |
| Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Class IMar 24, 2023A manufacturing error, resulted in a less than specified dia |
| COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal TuClass IIFeb 10, 2023Due to potential leaks associate with the Oral/Nasal Trachea |
| Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product NClass IIMar 5, 2021Investigations related to customer complaints received for p |