Data / Medical devices / United States / Covidien
Covidien: FDA-registered device maker in Lafayette, CO, United States, 96 510(k) clearances
Covidien is registered with the FDA (registration 2936999) in Lafayette, CO, United States. It lists 45 device types. The FDA files 96 510(k) clearances under its listings, the newest dated August 13, 2026. 41 recall events name it as the recalling firm (11 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2936999
- Address
- 200 Medtronic Dr, Lafayette, CO, United States, 80026
- Owner or operator
- Covidien llc (1282497)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 14, 1991
- Registered through
- 2027
- Brand names listed
- & Oximax Sensors, 18860 6MM TAPERGUARD EVAC TRACHAEL, 18865 6.5MM TAPERGUARD EVAC TRACHEAL 202, 18870 7MM TAPERGUARD EVAC TRACHEAL, 18875 7.5MM TAPERGUARD EVAC TRACHEAL, 18880 8MM TAPERGUARD EVAC TRACHEAL, 18885 8.5MM TAPERGUARD EVAC TRACHEAL, 18890 9MM TAPERGUARD EVAC TRACHEAL and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 13, 2026 | K260907 | BIS Advance pEEG Module | OLW | Substantially Equivalent | Covidien LP | accessdata.fda.gov |
| December 29, 2025 | K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT | JOH | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 29, 2025 | K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | BZT | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| October 6, 2025 | K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR) | BTR | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 25, 2025 | K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced | BTR | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| August 20, 2024 | K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044) | FLL | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 20, 2024 | K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) | BTR | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| August 30, 2023 | K223130 | Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) | BTR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 6, 2022 | K212555 | Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC | DQA | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 5, 2021 | K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) | MUD | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 17, 2021 | K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector | CCK | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 9, 2021 | K202874 | Puritan Bennett Cuff Pressure Manager | BSK | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| July 20, 2020 | K201179 | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable | DQA | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| June 1, 2020 | K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 22, 2019 | K182861 | Shiley Neonatal/Pediatric Tracheostomy Tube | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 8, 2019 | K182868 | INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor | MUD | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 15, 2017 | K172482 | The Nellcor pulse oximetry monitor interface cable | DQA | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 14, 2016 | K160718 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | MWI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 11, 2015 | K151381 | Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye | BTR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 14, 2015 | K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 26, 2015 | K142865 | Nellcor Bedside SpO2 Patient Monitoring System | DQA | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 5, 2015 | K141518 | Nellcor Bedside Respiratory Patient Monitoring System | DQA | Substantially Equivalent | Covidien | accessdata.fda.gov |
| February 24, 2015 | K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 2, 2014 | K141542 | NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) | DQA | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| April 10, 2014 | K140339 | VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM | MWI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| February 4, 2014 | K130320 | BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW | DQA | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 4, 2013 | K132604 | VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM | MWI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 29, 2013 | K131361 | WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET | DWJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 9, 2013 | K130796 | VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM | MWI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 9, 2013 | K123581 | NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN | DQA | Substantially Equivalent | Covidien, Formerly Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| April 17, 2013 | K123083 | COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT | DWJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 9, 2012 | K122531 | SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T | JOH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 10, 2012 | K120773 | NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM | DQA | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 15, 2012 | K111933 | COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 | BZQ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 23, 2009 | K093183 | BIS QUATRO SENSOR | GXY | Substantially Equivalent | Aspect Medical Systems, Inc. | accessdata.fda.gov |
| July 9, 2009 | K091224 | OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S | MUD | Substantially Equivalent | Somanetics Corp. | accessdata.fda.gov |
| April 3, 2009 | K090352 | TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 3, 2009 | K082327 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C | MUD | Substantially Equivalent | Somanetics Corp. | accessdata.fda.gov |
| October 2, 2008 | K082520 | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| June 16, 2005 | K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| December 13, 2004 | K033973 | OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR | NLF | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| July 6, 2004 | K041670 | BIS PEDIATRIC SENSOR | GXY | Substantially Equivalent | Aspect Medical Systems, Inc. | accessdata.fda.gov |
| November 25, 2003 | K031997 | MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM | BSY | Substantially Equivalent | Mallinckrodt Dar S.R.L. | accessdata.fda.gov |
| May 23, 2003 | K030930 | OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| September 24, 2002 | K022819 | NELLCOR N-200 PULSE OXIMETER, MODEL N-200 | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| May 8, 2002 | K021090 | OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| March 7, 2002 | K012891 | OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| January 11, 2002 | K014121 | WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 | DWJ | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| November 24, 1999 | K993637 | N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS | DQA | Substantially Equivalent | Nellcor Puritan Bennett, Inc. | accessdata.fda.gov |
| March 20, 1997 | K965132 | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| November 26, 1996 | K962045 | ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| October 4, 1996 | K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| March 13, 1996 | K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| January 24, 1996 | K954749 | MALLINCKRODT SHILEY 15MM CAP | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| August 11, 1995 | K953295 | ANESTHESIA FACE MASK | BSJ | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| June 8, 1995 | K952036 | FLEXLIFE | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| February 27, 1995 | K945407 | SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT | BTO | Substantially Equivalent | Mallinckrodt Medical Tpi, Inc. | accessdata.fda.gov |
| February 27, 1995 | K945406 | SSV PHONATE(TM) SHILEY SPEAKING VALVE | BTO | Substantially Equivalent | Mallinckrodt Medical Tpi, Inc. | accessdata.fda.gov |
| January 13, 1995 | K945513 | MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| September 27, 1994 | K944400 | PEDI-CAP | CCK | Substantially Equivalent | Nellcor, Inc. | accessdata.fda.gov |
| September 8, 1994 | K944124 | SPIROBAC ADAPTERS | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| August 22, 1994 | K942794 | HYGROLIFE | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| August 22, 1994 | K942392 | AIRWAY CONNECTOR WITH FLEX TUBE | BZA | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| May 20, 1994 | K941676 | STERIVENT AND STERIVENT S | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 19, 1994 | K941585 | HYGROSTER | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 19, 1994 | K941536 | BARRIERBAC AND BARRIERBAC S | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 15, 1994 | K941535 | TRACHEOLIFE | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 15, 1994 | K941381 | HYGROBAC,S HYGROBOY AND HYGROBABY | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 11, 1994 | K941246 | RAE II TRACHEAL TUBE | BTR | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| July 2, 1993 | K930895 | SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF | JOH | Substantially Equivalent | Mallinckrodt Medical Tpi, Inc. | accessdata.fda.gov |
| March 26, 1993 | K925615 | SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE | CBI | Substantially Equivalent | Sorin Biomedica, Fiat, USA, Inc. | accessdata.fda.gov |
| May 8, 1992 | K914887 | ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT | FRQ | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| September 4, 1991 | K913016 | WARMTOUCH | DWJ | Substantially Equivalent | Advanced Warming Systems, Inc. | accessdata.fda.gov |
| August 22, 1991 | K912240 | CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM | BYE | Substantially Equivalent | Mallinckrodt Anesthesia Products | accessdata.fda.gov |
| December 27, 1990 | K904039 | REFLECTANCE SENSOR (RS-10) | DQA | Substantially Equivalent | Nellcor, Inc. | accessdata.fda.gov |
| December 21, 1989 | K895875 | MODEL 4070 TEMPERATURE MONITOR | FLL | Substantially Equivalent | Mallinckrodt Anesthesia Products | accessdata.fda.gov |
| July 20, 1989 | K890194 | SHILEY SPECIALIZED TRACHEOSTOMY TUBE | JOH | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| March 14, 1989 | K890193 | SINGLE PATIENT USE NASAL (CPAP) CIRCUIT | BYG | Substantially Equivalent | Puritan Bennett Corp. | accessdata.fda.gov |
| January 17, 1989 | K884730 | SHILEY PERC TRACHEOSTOMY SYSTEM | BTO | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| January 29, 1988 | K874514 | HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE | FLL | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| January 19, 1988 | K875234 | MON-A-THERM'S SKIN TEMPERATURE SENSOR | FLL | Substantially Equivalent | Mon-A-Therm, Inc. | accessdata.fda.gov |
| November 6, 1987 | K873461 | LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) | BTR | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| April 21, 1987 | K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) | BTR | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| August 1, 1986 | K862666 | UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) | BTR | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| January 3, 1986 | K852632 | GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB | CAI | Substantially Equivalent | Medicomp, Inc. | accessdata.fda.gov |
| July 24, 1985 | K841092 | HIGH PRESSURE FLEX. CONNECTING TUBING | DXT | Substantially Equivalent | Tronomed, Inc. | accessdata.fda.gov |
| October 19, 1984 | K843730 | SHILEY DISPOS. DECANNULATION PLUG W/SW/ | BTO | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| July 26, 1984 | K841872 | UNCUFFED REINFORCED TRACHEAL TUBE | BTR | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| August 10, 1983 | K831567 | FOLEY-TEMP | KOD | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| July 10, 1981 | K811862 | HI-LO TEMP ESOPHAGEAL STETHOSCOPE | BZT | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| June 26, 1981 | K811447 | SHILEY DISPOSABLE CANNULA TRACH. TUBE | BTO | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| July 14, 1980 | K801239 | STERILE, DISP DOME, INDIVID. PKG. | DRS | Substantially Equivalent | Pacific Domes, Inc. | accessdata.fda.gov |
| April 13, 1979 | K790575 | TUBE, ARMORED TRACHEAL | BTR | Substantially Equivalent | National Patent Development Corp. | accessdata.fda.gov |
| August 4, 1977 | K771219 | BRONCHO-CATH | BTS | Substantially Equivalent | Mallinckrodt Critical Care | accessdata.fda.gov |
| July 19, 1976 | K760125 | AIRWAY, ARGYLE NASOPHARYNGEAL | BTQ | Substantially Equivalent | Sherwood Medical Industries | accessdata.fda.gov |
| July 16, 1976 | K760137 | TUBE, FEEDING, ARGYLE | FPD | Substantially Equivalent | Sherwood Medical Industries | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 23, 2026 | 98859 | Class II | Ongoing | Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042 | Temperature probe devices lack FDA clearance. | accessdata.fda.gov |
| April 23, 2026 | 98819 | Class II | Ongoing | Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS | Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. | accessdata.fda.gov |
| April 15, 2026 | 98813 | Class II | Ongoing | COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double c | Due to customer complaint regarding incorrect display box labeling. | accessdata.fda.gov |
| January 30, 2026 | 98407 | Class II | Ongoing | 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 / 10884521844940 Vital Sync | 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. | accessdata.fda.gov |
| June 23, 2025 | 96862 | Class II | Ongoing | 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 | accessdata.fda.gov |
| February 26, 2025 | 96371 | Class I | Ongoing | 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. | accessdata.fda.gov |
| July 9, 2024 | 95033 | Class I | Ongoing | 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. | accessdata.fda.gov |
| July 9, 2024 | 95032 | Class II | Ongoing | Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly | IFU update to address device's battery handling information. | accessdata.fda.gov |
| January 9, 2024 | 93883 | Class II | Ongoing | 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 | accessdata.fda.gov |
| September 28, 2023 | 93002 | Class I | Ongoing | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 | Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation. | accessdata.fda.gov |
| August 22, 2023 | 92941 | Class II | Ongoing | Puritan Bennett Cuff Pressure Manager, REF: 180-03 | Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay. | accessdata.fda.gov |
| August 10, 2023 | 92895 | Class II | Ongoing | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only | Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured. | accessdata.fda.gov |
| March 24, 2023 | 91943 | Class I | Ongoing | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CUFFED TRACH CAN; 10CN10R, 10.0MM ADT FLEX | A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding. | accessdata.fda.gov |
| February 10, 2023 | 91841 | Class II | Ongoing | COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesia or | Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system. | accessdata.fda.gov |
| April 13, 2016 | 73701 | Class I | Terminated | Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack | Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor. | accessdata.fda.gov |
| January 15, 2016 | 73096 | Class II | Terminated | Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation. | Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action notice for two issues on all models of Puritan Bennett 980 (PB980) ventilator. | accessdata.fda.gov |
| July 16, 2015 | 71675 | Class I | Terminated | Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechani | Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized. | accessdata.fda.gov |
| June 29, 2015 | 71583 | Class II | Terminated | OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. | Potential missing segments on the display that can result in misinterpretation of data. | accessdata.fda.gov |
| May 8, 2015 | 71197 | Class I | Terminated | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6.5PELF,2.5NCF,3.0NCF, | Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels. | accessdata.fda.gov |
| January 12, 2015 | 70239 | Class II | Terminated | Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respirator | Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds. | accessdata.fda.gov |
| October 1, 2014 | 69324 | Class I | Terminated | Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU. | Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor. | accessdata.fda.gov |
| October 1, 2014 | 69320 | Class I | Terminated | Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patien | A software issue may lead to ventilator inoperative situations. | accessdata.fda.gov |
| July 17, 2014 | 68802 | Class II | Terminated | Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platfo | Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system. | accessdata.fda.gov |
| June 4, 2014 | 68454 | Class II | Terminated | Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. | In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss of display and thus there is a necessity to move the patient to another ventilator. | accessdata.fda.gov |
| June 3, 2014 | 68444 | Class II | Terminated | Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory f | Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support. | accessdata.fda.gov |
| April 18, 2014 | 68099 | Class II | Terminated | Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, p | Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally. | accessdata.fda.gov |
| December 16, 2013 | 67108 | Class I | Terminated | Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients. | Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error. | accessdata.fda.gov |
| January 25, 2013 | 67163 | Class II | Terminated | Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-exp | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years. | accessdata.fda.gov |
| August 1, 2012 | 62705 | Class II | Terminated | DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures. | Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site. | accessdata.fda.gov |
| July 18, 2012 | 62559 | Class I | Terminated | Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway o | Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients. | accessdata.fda.gov |
| November 8, 2011 | 60372 | Not yet classified | Terminated | BIS Bilateral Sensors, part number, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc. Product Usage: To enable recordings of electrophysiological | During manufacture, circuit traces were reversed which causes inaccurate display of information. | accessdata.fda.gov |
| April 13, 2010 | 55354 | Not yet classified | Terminated | Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, p | Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation. | accessdata.fda.gov |
| August 14, 2009 | 52927 | Not yet classified | Terminated | Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediCap). Intended for use during endotracheal | CO2 detector may increase resistance to air flow in an intubated patient. | accessdata.fda.gov |
| January 14, 2009 | 51160 | Not yet classified | Terminated | Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The product is provided as one each shipped in an | Difficulty inserting an obturator and/or suction catheter into the tracheostomy tube. | accessdata.fda.gov |
| March 21, 2008 | 47523 | Not yet classified | Terminated | Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA | Wiring in battery back-up power supply may short and cause thermal damage to ventilator. | accessdata.fda.gov |
| March 12, 2007 | 37607 | Not yet classified | Terminated | Puritan Bennett 840 Ventilator System, Catalogue Numbers: 4-84O12OXXXX-XX, 4-840220XXXX-XX, 4-NPB84O-XX, DL4-NPB84O-XX, DS4-NPB840-XX & 4-070550-SP (Note: the Xs indicate any combination of alpha characters which specify | In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, the ventilator will annunciate a high-urgency audible alarm and the ventilator will not resume normal operation. | accessdata.fda.gov |
| July 12, 2006 | 35879 | Not yet classified | Terminated | Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20 | Product's outer sheath material may separate from the wire interior during use and may lodge in the endotracheal tube or enter the patient's airway and interfere with ventilation. | accessdata.fda.gov |
| December 9, 2004 | 31273 | Not yet classified | Terminated | Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexT | Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury. | accessdata.fda.gov |
| October 18, 2004 | 31271 | Not yet classified | Terminated | Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland, Oxismart, Made in Ireland; Distributed by Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 U.S.A. | The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency. | accessdata.fda.gov |
| August 24, 2004 | 29892 | Not yet classified | Terminated | The probes involved have been part of the Nellcor CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a me | The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis. | accessdata.fda.gov |
| July 8, 2004 | 29653 | Not yet classified | Terminated | Shiley TracheoSoft XLT Extended Length Tracheostomy tube; Model Numbers: 72110-050, size 5, Proximal Extension, Uncuffed; 72110-060, size 6, Proximal Extension, Uncuffed; 72110-070, size 7, Proximal Extension, Uncuffed; | Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death. | accessdata.fda.gov |
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Updated August 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.