Covidien LLC

Complete recall history across all FDA and CPSC categories — 329 total recalls

Covidien LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (329)

FDA medical device enforcement actions by Covidien LLC. Showing most recent 50.

Date Product Reason Class
Jan 30, 2026 HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: ... Due to complaints and investigations stating that alarms from the primary pat... Class II
Aug 19, 2022 Puritan Bennett 560 Ventilator, PB560, CFN 4096600 Medtronic has confirmed six reports from customers outside the US where the v... Class II
Jun 8, 2022 Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and ... There is a potential leaking condition within the hub of specific chronic dia... Class I
Jun 8, 2022 Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For v... There is a potential leaking condition within the hub of specific chronic dia... Class I
Jun 8, 2022 Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For va... There is a potential leaking condition within the hub of specific chronic dia... Class I
Jun 8, 2022 Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular acces... There is a potential leaking condition within the hub of specific chronic dia... Class I
Jun 8, 2022 Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. F... There is a potential leaking condition within the hub of specific chronic dia... Class I
Jun 8, 2022 Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and c... There is a potential leaking condition within the hub of specific chronic dia... Class I
Jun 8, 2022 Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and ch... There is a potential leaking condition within the hub of specific chronic dia... Class I
Jun 8, 2022 Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For ... There is a potential leaking condition within the hub of specific chronic dia... Class I
Jun 8, 2022 Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vasc... There is a potential leaking condition within the hub of specific chronic dia... Class I
Jun 7, 2022 TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet t... Electrical component failure within the control unit. The observed failure mo... Class II
Dec 17, 2021 Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon C... The firm has received six (6) complaint reports from customers indicating dif... Class II
Dec 6, 2021 LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number L... Customers reported that the device jaws were difficult to open or would not o... Class II
Nov 12, 2021 Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusabl... Intermittent risk of electric shock to users if an affected charger is used i... Class II
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1PLDIPC Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X3JADIJJ Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980U3ESDIUU Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator,980X1ENAIQC Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1JADIJJ Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980A1ENNISB Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1ENDIUU Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980S1ENDICU Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1ENDIPC Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980A3ENNISB Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980S3ENDICU Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X1ENNISB Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X3ENDIUU Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980U1ENASAA Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980U1ESDIUC Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Nov 4, 2021 Puritan Bennett 980 Series Ventilator, 980X2ESDIEC Manufacturing assembly error where a capacitor within the ventilator was asse... Class I
Sep 29, 2021 Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic... The firm identified an error in the device temperature monitoring circuitry w... Class II
Jun 23, 2021 Covidien Sonicision Reusable Generator-converts electrical power from the bat... Potential for a manufacturing assembly error-may result in a non-functional a... Class II
Mar 23, 2021 Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For ... Potential for the pouch to contain an extra laminate layer, creating the pote... Class II
Feb 26, 2021 BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended t... The capsule may fail to attach to the esophageal mucosa, which in turn may le... Class II
Feb 26, 2021 CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to... The capsule may fail to attach to the esophageal mucosa, which in turn may le... Class II
Jan 13, 2021 Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - ... incorrect device is contained in the package. The packaging label indicates t... Class II
Nov 23, 2020 Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3... May contain a damaged internal component which could impede staple deployment... Class II
Nov 23, 2020 Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 m... May contain a damaged internal component which could impede staple deployment... Class II
Nov 16, 2020 Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN... The firm has released software update V01.05.02.16 (also known as V1.5.2) in ... Class II
Oct 16, 2020 Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on pat... In-house lab observations and customer reports of overheating and/or thermal ... Class II
Jun 26, 2020 Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-us... This voluntary recall is being conducted following three customer reports of ... Class II
Jun 26, 2020 Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-u... This voluntary recall is being conducted following three customer reports of ... Class II
May 12, 2020 Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Pro... The product is recalled due to a manufacturing assembly error that may cause ... Class II
May 12, 2020 Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Par... The product is recalled due to a manufacturing assembly error that may cause ... Class II
May 12, 2020 Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Par... The product is recalled due to a manufacturing assembly error that may cause ... Class II
May 12, 2020 Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Pro... The product is recalled due to a manufacturing assembly error that may cause ... Class II
Apr 30, 2020 Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 40... Temperature sensing catheters failed to meet the established calibrated temp... Class II
Apr 30, 2020 Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL F... Temperature sensing catheters failed to meet the established calibrated temp... Class II
Apr 30, 2020 Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley T... Temperature sensing catheters failed to meet the established calibrated temp... Class II

View all 329 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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