Covidien LLC Recalls

13 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (13)

January 30, 2026
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 1
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Class II
June 23, 2025
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
Class II
May 21, 2025
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, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
Class I
February 26, 2025
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
Class I
July 9, 2024
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
Class I
July 9, 2024
McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
Class I
July 9, 2024
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
IFU update to address device's battery handling information.
Class II
June 24, 2024
Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02
Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some components in the ventilator gas pathway
Class I
April 25, 2024
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
Class II
February 21, 2024
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.
Class II
January 9, 2024
Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
Class II
January 9, 2024
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
Class II
November 16, 2023
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable
Class II

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