--- title: "Covidien Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Covidien recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/covidien/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Covidien recall records **17** reported ongoing 17 records in this archive. Latest source date Jun 23, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 23, 2025 FDA device enforcement ### [Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN](https://isitonrecall.com/recall/fda-device-z-2151-2025-covidien-nellcor-bedside-spo2-patient-monitoring-system-ref-pm100n-10005941-dlpm100n-dl10005941-dspm/) 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 vol... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MS, TX, FL, SC, VA, AZ, PA, MN, OH, CA, MI, CO, KS, IN, IL, TN, MO, IA, OK, WI, AK, NY, MD, AL, WV, GA, NC, AR,... [Official source for Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2151-2025%22) May 21, 2025 FDA device enforcement ### [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-...](https://isitonrecall.com/recall/fda-device-z-1915-2025-newport-ht70-ventilator-ref-ht70m-jp-na-ht70m-cn-na-ht70m-es-eu-ht70m-pt-br-ht70m-sy-eu-ht70m-ww-eu/) 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 al... Class I Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN, AL, IA, NY, UT, NM, KY, RI, SD, PA, IA, CA, MO, HI, MI, IL,... [Official source for Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1915-2025%22) Feb 26, 2025 FDA device enforcement ### [Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R](https://isitonrecall.com/recall/fda-device-z-1390-2025-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 ... Class I Reported ongoing Distribution: OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan [Official source for Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1390-2025%22) Jul 9, 2024 FDA device enforcement ### [McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only](https://isitonrecall.com/recall/fda-device-z-2636-2024-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 Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC,... [Official source for McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2636-2024%22) Jul 9, 2024 FDA device enforcement ### [McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only](https://isitonrecall.com/recall/fda-device-z-2637-2024-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 Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC,... [Official source for McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2637-2024%22) Jul 9, 2024 FDA device enforcement ### [Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly](https://isitonrecall.com/recall/fda-device-z-2717-2024-covideien-mcgrath-mac-video-laryngoscope-ref-301-000-000-non-sterile-rxonly/) IFU update to address device's battery handling information. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC,... [Official source for Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2717-2024%22) Jun 24, 2024 FDA device enforcement ### [Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILA...](https://isitonrecall.com/recall/fda-device-z-2446-2024-puritan-bennett-500-series-ventilators-description-ref-puritan-bennett-560-ventilator-4096600-purita/) 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 pos... Class I Reported ongoing Distribution: US: KY, OH, GA, MN, IN,UT, IL, NJ, NY, PR, LA, MD, MO, TN, MA, ME, CA, SC, AR, TX, WI, PA, CO, MI, NM, RI, VA, DC, VT, NC, NH, WV, NV, IA. OUS: Argentina, Australia, Bangladesh,... [Official source for Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600,...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2446-2024%22) Feb 21, 2024 FDA device enforcement ### [Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1](https://isitonrecall.com/recall/fda-device-z-1330-2024-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-ste... Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, RI, TN, TX, UT, VA,... [Official source for Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1330-2024%22) Jan 9, 2024 FDA device enforcement ### [Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC](https://isitonrecall.com/recall/fda-device-z-1731-2024-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 Reported ongoing Distribution: US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany ... [Official source for Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1731-2024%22) Jan 9, 2024 FDA device enforcement ### [Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC](https://isitonrecall.com/recall/fda-device-z-1732-2024-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 Reported ongoing Distribution: US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany ... [Official source for Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1732-2024%22) Nov 16, 2023 FDA device enforcement ### [Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD](https://isitonrecall.com/recall/fda-device-z-0631-2024-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 Reported ongoing Distribution: Worldwide distribution - US: Nationwide and surrounding territories. [Official source for Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0631-2024%22) Sep 28, 2023 FDA device enforcement ### [Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000](https://isitonrecall.com/recall/fda-device-z-0144-2024-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. Class I Reported ongoing Distribution: Unknown [Official source for Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0144-2024%22) Aug 22, 2023 FDA device enforcement ### [Puritan Bennett Cuff Pressure Manager, REF: 180-03](https://isitonrecall.com/recall/fda-device-z-2651-2023-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 treatm... Class II Reported ongoing Distribution: US: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El Salvador, Sweden, Canary Islands [Official source for Puritan Bennett Cuff Pressure Manager, REF: 180-03](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2651-2023%22) Aug 10, 2023 FDA device enforcement ### [McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only](https://isitonrecall.com/recall/fda-device-z-0168-2024-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. Class II Reported ongoing Distribution: US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY OUS: Australia Austria Azerbaijan Bahamas Belgium Croatia C... [Official source for McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0168-2024%22) Aug 10, 2023 FDA device enforcement ### [McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only](https://isitonrecall.com/recall/fda-device-z-0169-2024-mcgrath-mac-2-disposable-laryngoscope-blade-ref-350-084-000-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. Class II Reported ongoing Distribution: US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY OUS: Australia Austria Azerbaijan Bahamas Belgium Croatia C... [Official source for McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0169-2024%22) Mar 24, 2023 FDA device enforcement ### [Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY...](https://isitonrecall.com/recall/fda-device-z-1357-2023-shiley-adult-flexible-tracheostomy-tube-with-taperguard-cuff-and-cuffless-disposable-inner-cannula-o/) 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 re... Class I Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of PR, CA, FL, MN, PA, AZ, IL, TN, OH, MI, GA, KS, HI, MD, AK, NY, NE, IA, OK, VA, ND, MO, NC, SC, KY, OR, IN, WA,... [Official source for Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cann...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1357-2023%22) Feb 10, 2023 FDA device enforcement ### [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 ...](https://isitonrecall.com/recall/fda-device-z-1318-2023-covidien-shiley-lo-pro-oral-nasal-tracheal-tube-cuffed-ref-86051-7-0-mm-i-d-the-shiley-lo-pro-oral-n/) Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system. Class II Reported ongoing Distribution: U.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA, and WV O.U.S.: Canada [Official source for COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Or...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1318-2023%22) ## Reasons in these listed records - 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 al... - 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 duri... - 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 a... - Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion. These examples come from this result page and are not a ranking of every recall reason. ## Checking Covidien ### Is there a recall on covidien right now? This archive contains 17 records, including 17 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Covidien](https://isitonrecall.com/check/?q=Covidien) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)