PlainRecalls

Covidien LLC

Compiled from official public sources by the editorial team.

335 recalls on record · Latest: Mar 18, 2026

Covidien LLC Recall Insight

Covidien LLC appears on 335 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.329% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 18, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 25 critical, 25 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Jun 10, 2020 to Mar 18, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Mar 18, 2026

HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vita…

FDA Devices Moderate Jun 19, 2024

EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

FDA Devices Moderate Aug 9, 2023

Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM

FDA Devices Moderate Jul 5, 2023

Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS

FDA Devices Moderate Jan 18, 2023

COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

FDA Devices Moderate Sep 28, 2022

Puritan Bennett 560 Ventilator, PB560, CFN 4096600

FDA Devices Moderate Aug 3, 2022

TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808

FDA Devices Critical Jul 13, 2022

Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

FDA Devices Critical Jul 13, 2022

Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

FDA Devices Critical Jul 13, 2022

Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

FDA Devices Critical Jul 13, 2022

Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

FDA Devices Critical Jul 13, 2022

Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

FDA Devices Critical Jul 13, 2022

Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

FDA Devices Critical Jul 13, 2022

Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusio…

FDA Devices Critical Jul 13, 2022

Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusi…

FDA Devices Critical Jul 13, 2022

Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

FDA Devices Moderate Feb 9, 2022

Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbe…

FDA Devices Moderate Jan 19, 2022

LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980X2ESDIEC

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980U1ESDIUC

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980U1ENASAA

FDA Devices Moderate Dec 15, 2021

Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progre…

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980X3ENDIUU

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980X1ENNISB

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980S3ENDICU

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980A3ENNISB

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980X1ENDIPC

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980S1ENDICU

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980X1ENDIUU

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980A1ENNISB

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980X1JADIJJ

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator,980X1ENAIQC

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980U3ESDIUU

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980X3JADIJJ

FDA Devices Critical Dec 15, 2021

Puritan Bennett 980 Series Ventilator, 980X1PLDIPC

FDA Devices Moderate Nov 17, 2021

Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

FDA Devices Moderate Aug 18, 2021

Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Numb…

FDA Devices Moderate Apr 21, 2021

Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applicati…

FDA Devices Moderate Apr 7, 2021

CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric r…

FDA Devices Moderate Apr 7, 2021

BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric …

FDA Devices Moderate Mar 3, 2021

Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparosco…

FDA Devices Moderate Jan 6, 2021

Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic sur…

FDA Devices Moderate Jan 6, 2021

Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical…

FDA Devices Moderate Dec 9, 2020

Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and…

FDA Devices Moderate Nov 18, 2020

Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require res…

FDA Devices Moderate Aug 12, 2020

Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.…

FDA Devices Moderate Aug 12, 2020

Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5…

FDA Devices Moderate Jun 10, 2020

Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for…

FDA Devices Moderate Jun 10, 2020

Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surg…

FDA Devices Moderate Jun 10, 2020

Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surg…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Covidien LLC with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.