--- title: "Covidien Llc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Covidien Llc 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-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Covidien Llc recall records **24** reported ongoing 41 records in this archive. Latest source date May 13, 2026. 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 May 13, 2026 FDA device enforcement ### [EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 1088452...](https://isitonrecall.com/recall/fda-device-z-2950-2026-endoflip-system-that-includes-endoflip-1-system-ef-100-05391530810050-10884521809307-refurbished-sys/) The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, O... [Official source for EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2950-2026%22) Apr 23, 2026 FDA device enforcement ### [Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042](https://isitonrecall.com/recall/fda-device-z-2271-2026-covidien-mon-a-therm-esophageal-stethoscope-with-temperature-sensor-400tm-ref-90042/) Temperature probe devices lack FDA clearance. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA,... [Official source for Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2271-2026%22) Apr 23, 2026 FDA device enforcement ### [Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044](https://isitonrecall.com/recall/fda-device-z-2272-2026-covidien-mon-a-therm-general-purpose-temperature-probe-ref-90044/) Temperature probe devices lack FDA clearance. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA,... [Official source for Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2272-2026%22) Apr 23, 2026 FDA device enforcement ### [Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050](https://isitonrecall.com/recall/fda-device-z-2273-2026-covidien-mon-a-therm-general-purpose-temperature-probe-size-9-fr-ref-90050/) Temperature probe devices lack FDA clearance. Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA,... [Official source for Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2273-2026%22) Apr 23, 2026 FDA device enforcement ### [Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Numb...](https://isitonrecall.com/recall/fda-device-z-2653-2026-covidien-shiley-disposable-decannulation-plug-ref-ddcp-udi-di-code-10884522004060-product-codes-that/) Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. Class II Reported ongoing Distribution: U.S. Nationwide distribution including in the states and territories 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, M... [Official source for Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2653-2026%22) Apr 15, 2026 FDA device enforcement ### [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 managem...](https://isitonrecall.com/recall/fda-device-z-2261-2026-covidien-shiley-tracheostomy-tube-cuffed-with-inner-cannula-ref-6fen-udi-di-code-60884522007028-the/) Due to customer complaint regarding incorrect display box labeling. Class II Reported ongoing Distribution: Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan. [Official source for COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2261-2026%22) Jan 30, 2026 FDA device enforcement ### [HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vi...](https://isitonrecall.com/recall/fda-device-z-1557-2026-healthcast-vital-sync-remote-patient-monitoring-system-which-consists-of-product-number-vslbase03p-v/) 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 Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain. [Official source for HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBA...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1557-2026%22) Apr 25, 2024 FDA device enforcement ### [EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only](https://isitonrecall.com/recall/fda-device-z-2038-2024-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 Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA,... [Official source for EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2038-2024%22) Jun 2, 2023 FDA device enforcement ### [Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM](https://isitonrecall.com/recall/fda-device-z-2282-2023-covidien-cytosponge-cell-collection-device-ref-cyto-201-and-covidien-cytosponge-cell-collection-kit/) Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary interv... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom. [Official source for Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collectio...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2282-2023%22) May 22, 2023 FDA device enforcement ### [Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS](https://isitonrecall.com/recall/fda-device-z-2008-2023-medtronic-illumisite-platform-console-model-number-ils-1000-cs/) Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer. Class II Reported ongoing Distribution: International distribution in the country of Taiwan. [Official source for Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2008-2023%22) Nov 23, 2022 FDA device enforcement ### [COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1](https://isitonrecall.com/recall/fda-device-z-0955-2023-covidien-emprint-ablation-catheter-with-thermosphere-technology-bronchoscopic-ablation-ref-ca108l1/) The product is labeled with the incorrect expiration date. Class II Reported ongoing Distribution: Foreign Distribution: Hong Kong [Official source for COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0955-2023%22) Aug 19, 2022 FDA device enforcement ### [Puritan Bennett 560 Ventilator, PB560, CFN 4096600](https://isitonrecall.com/recall/fda-device-z-1775-2022-puritan-bennett-560-ventilator-pb560-cfn-4096600/) Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components. Class II Reported ongoing Distribution: Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide. [Official source for Puritan Bennett 560 Ventilator, PB560, CFN 4096600](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1775-2022%22) Jun 8, 2022 FDA device enforcement ### [Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.](https://isitonrecall.com/recall/fda-device-z-1312-2022-palindrome-precision-chronic-catheter-sterile-single-use-rx-only-for-vascular-access-for-acute-and-c/) There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ... [Official source for Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acut...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1312-2022%22) Jun 8, 2022 FDA device enforcement ### [Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.](https://isitonrecall.com/recall/fda-device-z-1313-2022-palindrome-precision-h-chronic-catheter-sterile-single-use-rx-only-for-vascular-access-for-acute-and/) There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ... [Official source for Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for ac...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1313-2022%22) Jun 8, 2022 FDA device enforcement ### [Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.](https://isitonrecall.com/recall/fda-device-z-1314-2022-palindrome-precision-si-chronic-catheter-sterile-single-use-rx-only-for-vascular-access-for-acute-an/) There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ... [Official source for Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for a...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1314-2022%22) Jun 8, 2022 FDA device enforcement ### [Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.](https://isitonrecall.com/recall/fda-device-z-1315-2022-palindrome-precision-hsi-chronic-catheter-sterile-single-use-rx-only-for-acute-and-chronic-hemodialy/) There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ... [Official source for Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic he...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1315-2022%22) Jun 8, 2022 FDA device enforcement ### [Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.](https://isitonrecall.com/recall/fda-device-z-1316-2022-palindrome-chronic-catheter-sterile-single-use-rx-only-for-vascular-access-for-acute-and-chronic-hem/) There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ... [Official source for Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chro...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1316-2022%22) Jun 8, 2022 FDA device enforcement ### [Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.](https://isitonrecall.com/recall/fda-device-z-1317-2022-palindrome-h-chronic-catheter-sterile-single-use-rx-only-for-acute-and-chronic-hemodialysis-apheresi/) There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ... [Official source for Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1317-2022%22) Jun 8, 2022 FDA device enforcement ### [Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.](https://isitonrecall.com/recall/fda-device-z-1318-2022-palindrome-si-chronic-catheter-sterile-single-use-rx-only-for-acute-and-chronic-hemodialysis-apheres/) There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ... [Official source for Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis,...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1318-2022%22) Jun 8, 2022 FDA device enforcement ### [Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.](https://isitonrecall.com/recall/fda-device-z-1319-2022-palindrome-hsi-chronic-catheter-sterile-single-use-rx-only-for-acute-and-chronic-hemodialysis-aphere/) There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ... [Official source for Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1319-2022%22) ## Reasons in these listed records - The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. - Temperature probe devices lack FDA clearance. - Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. - Due to customer complaint regarding incorrect display box labeling. These examples come from this result page and are not a ranking of every recall reason. ## Checking Covidien Llc ### Is there a recall on covidien llc right now? This archive contains 41 records, including 24 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 Llc](https://isitonrecall.com/check/?q=Covidien%20Llc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)