Covidien LLC recalls
Every recall we track for Covidien LLC — 152 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 14 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Covidien LLC peaked in 2019 (44); 152 since 2017. 9% rated “stop using now”.
All FDA recall records for Covidien LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 6 | 4 | 1 | 1 | 12 |
| 2018 | 4 | 2 | 18 | 1 | 25 |
| 2019 | 3 | 10 | 31 | 0 | 44 |
| 2020 | 0 | 12 | 12 | 0 | 24 |
| 2021 | 1 | 16 | 8 | 0 | 25 |
| 2022 | 0 | 8 | 4 | 0 | 12 |
| 2023 | 0 | 1 | 0 | 1 | 2 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 1 | 3 | 3 | 7 |
Most common reasons for Covidien LLC recalls
What to do if you have a recalled Covidien LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Covidien LLC recalls
53 shown- Lower riskMedical device
Covidien, LLC recalls EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100
Covidien recalls EndoFLIP 1 System catheters that may be incorrectly flagged as expired after January 1, 2026, risking clinical procedure delays.
CovidienMay 13, 2026 - Lower riskMedical device
Covidien LLC recalls Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the
Covidien recalls disposable decannulation plugs with incorrect DEHP labeling that may include harmful phthalates. Affected products have specific UDI-DI codes and product numbers for tracheostomy tube access.
CovidienApr 23, 2026 - UnratedMedical device
Covidien LLC recalls Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Covidien recalls Mon-a-Therm temperature probes (size 9 Fr REF 90050) due to lack of FDA clearance. Affected units have specific UDI and lot numbers. Consumers should contact the manufacturer for details.
CovidienApr 23, 2026 - Lower riskMedical device
Covidien LLC recalls COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are
Covidien recalls Shiley Tracheostomy Tubes with incorrect box labeling. Affected units may have mislabeled packaging, but no safety hazard exists. Contact for details.
CovidienApr 15, 2026 - Use cautionMedical device
Covidien LLC recalls HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03
HealthCast recalls Vital Sync remote patient monitoring systems with specific model numbers due to alarms not transmitting properly, potentially missing critical health alerts.
HealthCastJan 30, 2026 - Lower riskMedical device
Covidien, LLC recalls EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Covidien recalls EsoFLIP 30mm balloon dilation catheters (REF ES-330) due to potential inaccurate esophageal diameter measurements that could lead to harmful outcomes. Affected units include specific lots from 2022-2024.
CovidienApr 25, 2024 - Use cautionMedical device
Covidien, LLC recalls Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF:
Covidien recalls Cytosponge Cell Collection Devices and Kits with specific serial numbers due to risk of sponge detaching during removal, potentially causing airway obstruction or aspiration.
CovidienJun 2, 2023 - UnratedMedical device
Covidien, LLC recalls Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Medtronic recalls ILLUMISITE Platform Console Model ILS-1000-CS with 120VAC power cord installed by field service, risking electrical hazards. Affected units have specific serial numbers and UDI-DI codes.
MedtronicMay 22, 2023 - Lower riskMedical device
Covidien, LLC recalls COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Covidien recalls Emprint Ablation Catheters with incorrect expiration dates. Affected units have a specific lot number and GTIN. Consumers should check their product details to determine if they are affected.
CovidienNov 23, 2022 - Use cautionMedical device
Covidien Llc recalls Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Covidien recalls Puritan Bennett 560 ventilators with specific serial numbers due to potential gas supply failure from manufacturing errors in turbine components. Affected units may become inoperable outside the US.
CovidienAug 19, 2022 - Lower riskMedical device
Covidien Llc recalls Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic
Covidien is a leading manufacturer of medical devices, including surgical instruments, endoscopic equipment, and more.
CovidienJun 8, 2022 - Use cautionMedical device
Covidien Llc recalls TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue
Covidien recalls TruClear Hysteroscopic Tissue Removal System Control Units with electrical component failure risk. Affected units have specific serial numbers. Stop using immediately to prevent loss of function during procedures.
CovidienJun 7, 2022 - Use cautionMedical device
Covidien Llc recalls Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm;
Covidien recalls two types of Chameleon PTA Balloon Catheters due to difficulty removing the balloon protector sleeve, which may cause patient harm if the catheter is used after damage.
CovidienDec 17, 2021 - Use cautionMedical device
Covidien Llc recalls LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Covidien recalls LigaSure Blunt Tip Laparoscopic Sealer/Divider (LF1837) due to jaws that may not open, risking bleeding and tissue injury during surgery.
CovidienDec 6, 2021 - Stop using nowMedical device
Covidien Llc recalls Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information
Covidien recalls Sonicision Battery Chargers with serial numbers MCSB006939 and MCSB006: Risk of electric shock if used with faulty ground circuit. Stop using immediately.
CovidienNov 12, 2021 - Lower riskMedical device
Covidien Llc recalls Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Covidien recalls Puritan Bennett 980 Series ventilators with specific serial numbers due to a manufacturing error that may cause the device to become inoperable during use. Affected units include serial numbers 35B1700627-35B1700632.
CovidienNov 4, 2021 - Use cautionMedical device
Covidien Llc recalls Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Covidien recalls Emprint Ablation Catheter with Thermosphere Technology (CFN CA108L1) due to temperature monitoring error that could cause overheating and tissue damage if primary cooling fails.
CovidienSep 29, 2021 - Use cautionMedical device
Covidien Llc recalls Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive
Covidien recalls specific Sonicision Reusable Generators due to potential manufacturing errors that may cause device failure, leading to injury risks like burns or tissue damage during medical procedures.
CovidienJun 23, 2021 - Lower riskMedical device
Covidien Llc recalls Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple
Covidien recalls Tri-Staple 2.0 Reinforced Intelligent Reload 60mm staples for potential sterility compromise due to extra laminate layer, risking patient infection or ethylene oxide exposure.
CovidienMar 23, 2021 - Use cautionMedical device
Covidien Llc recalls CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH
Covidien recalls CF Delivery Dev Caps Bravo x5 (FGS-0635/FGS-0636) for risk of capsule aspiration leading to low oxygen, intubation, and hospital stay. 13 reports of aspiration in 2 years.
CovidienFeb 26, 2021 - Use cautionMedical device
Covidien Llc recalls Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of
Covidien recalls 15x10cm polyester mesh for inguinal hernia repair due to incorrect side labeling. Using right-side mesh for left-side repairs risks hernia recurrence. Affected items have specific item code and lot numbers.
CovidienJan 13, 2021 - Use cautionMedical device
Covidien Llc recalls Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal,
Covidien recalls TA Auto Suture Vascular Loading Unit V3 (model TA30V3L) with specific lot numbers due to potential damaged internal components that may cause incomplete staple formation, leading to bleeding, infection, or other complications during surgery.
CovidienNov 23, 2020 - Lower riskMedical device
Covidien Llc recalls Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage:
Covidien recalls Capnostream 35 Portable Respiratory Monitors with serial numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02. Software update V01.05.02.16 (V1.5.2) addresses false temperature alerts that trigger automatic shutdown without alarm.
CovidienNov 16, 2020 - Lower riskMedical device
Covidien Llc recalls Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU)
35B
35BOct 16, 2020 - Use cautionMedical device
Covidien Llc recalls Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting
Covidien recalls Beacon EUS Access System Preloaded Access 135-degree needle for potential cannula detachment during procedures, risking delayed treatment, biliary leaks, or retained fragments.
CovidienJun 26, 2020 - Use cautionMedical device
Covidien Llc recalls Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic
Covidien recalls Multifire VersaTrack Auto Suture Hernia Stapler (4.0mm, Part No. 174021) due to a manufacturing error that may cause staples to fail advancing when handle is compressed. Affected lots: P9J0241Y, P9J0242Y, P9J0243Y, P9K1140Y, P9K1663Y, P9K1141Y.
CovidienMay 12, 2020 - Use cautionMedical device
Covidien Llc recalls Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT
Covidien recalls 16FR silicone coated foley catheters with temperature sensors due to potential inaccurate temperature readings, which could lead to incorrect diagnoses and inadequate treatment. Affected units were sold with specific product codes and lot numbers.
CovidienApr 30, 2020 - Lower riskMedical device
Covidien Llc recalls Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa)
Covidien recalls EMEA-distributed surgical kits with potential infection risk due to sterile packaging compromise. Affected kits include specific model codes and lots.
CovidienFeb 10, 2020 - Lower riskMedical device
COVIDIEN LLC recalls Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code:
Covidien recalls 12mm Endo GIA Ultra Universal Staplers for potential infection risk if sterile barrier is compromised. Affected items have specific item codes and lot numbers.
CovidienJan 17, 2020 - Lower riskMedical device
Covidien LLC recalls Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft
Covidien recalls specific Polysorb suture lots due to potential packaging issues that could affect humidity or sterility. Affected items may not be safe for surgery.
CovidienDec 18, 2019 - Use cautionMedical device
Covidien LLC recalls EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
Covidien recalls EGIA 45 Articulating Xtra Thick Sulu surgical devices that may cause incomplete staple formation, leading to bleeding, infection, or severe complications. Affected units include specific item codes.
CovidienMay 17, 2019 - Lower riskMedical device
COVIDIEN LLC recalls MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009
Covidien recalls MAHURKAR and Argyle acute hemodialysis catheters with incorrect priming volume values that may lead to improper catheter filling during dialysis.
CovidienApr 29, 2019 - Lower riskMedical device
COVIDIEN LLC recalls Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has
Covidien recalls 5mm Endo Clinch II Auto Suture Graspers with inconsistent sterilization method. This may affect surgical safety. Contact for remedy details.
CovidienMar 13, 2019 - Lower riskMedical device
COVIDIEN LLC recalls Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Covidien recalls Kendall SCD Express Sterile Sleeves (Thigh Length) Model 9736 due to failure to meet sterility requirements. Product distributed without sterilization prior to distribution.
CovidienFeb 15, 2019 - Stop using nowMedical device
Covidien LLC recalls Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous,
Covidien recalls Emprint Standard Percutaneous Antenna with Thermosphere Technology (CA20L2) due to risk of ceramic tip remaining in patient after surgery. Affected units have specific lot numbers.
CovidienNov 15, 2018 - Stop using nowMedical device
COVIDIEN LLC recalls 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
Covidien recalls 8Fr Safe Grad Cat W/Valve (Argyle Suction Catheter Kits with Chimney Valve) Model 36826 due to import refusal. Affected units sold with Lot 1816211: stop using immediately.
CovidienNov 5, 2018 - Lower riskMedical device
COVIDIEN LLC recalls Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem
Covidien recalls Salem Sump Dual Lumen Stomach Tubes with incorrect packaging that may cause decreased fluid collection and affect patient care, especially in emergencies.
CovidienOct 31, 2018 - Lower riskMedical device
Covidien LLC recalls Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder
Covidien recalls Parietex composite parastomal mesh (PCOPM15/20) due to reported hernia recurrence after surgery. Patients should monitor for discomfort or bulging and consult their healthcare provider.
ParietexOct 5, 2018 - Lower riskMedical device
COVIDIEN LLC recalls Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980
Puritan Bennett recalls 980 ventilators with serial numbers 35B1300001-35B1801541 for potential GUI display errors from USB drive performance. Owners should check serial numbers and contact the company.
Puritan BennettSep 18, 2018 - Lower riskMedical device
COVIDIEN LLC recalls EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage:
Covidien recalls EEA Circular Staplers with Tri-Staple Technology due to potential incorrect tissue gap causing incomplete staples or tissue trauma. No serious injuries reported.
CovidienAug 17, 2018 - Lower riskMedical device
COVIDIEN LLC recalls Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both
Covidien recalls Kerlix bandage rolls with potential sterility breach due to seal defects. Affected lots: 18E071762, 18E072262, 18E072362, 18E132262, 18E132362. Stop using if seal appears pinched.
CovidienAug 1, 2018 - Lower riskMedical device
Covidien LLC recalls Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device
Covidien recalls Li-ion battery packs for BIS Vista and BIS View Monitoring Systems with date code 3114 or older (week 31, 2014) due to revised replacement instructions.
CovidienJul 26, 2018 - Lower riskMedical device
COVIDIEN LLC recalls P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS
Covidien recalls P400 PREM U/M 18FR TMPSNS with defective temperature sensors that may show lower body temperature than actual. Affected units have item code P4P18TS.
CovidienJul 11, 2018 - UnratedMedical device
Covidien LLC recalls Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Covidien recalls Polysorb Braided Absorbable Suture 1 36" 90 cm Undy: potential proplylene glycol contamination. Affected units have specific product numbers and lot codes.
CovidienJun 15, 2018 - Use cautionMedical device
Covidien LLC recalls EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 -
Covidien recalls hemorrhoid and prolapse stapler sets with DST Series Technology 3.5MM for potential improper staple formation causing bleeding or anastomotic leaks.
CovidienApr 9, 2018 - Lower riskMedical device
Covidien LLC recalls LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use
Covidien recalls LigaSure Exact Dissector Nano surgical tools with possible sterile breaches in packaging. Affected units include specific lot numbers from 72550127X to 73000048X. Consumers should check their product details.
CovidienMar 15, 2018 - Lower riskMedical device
Covidien LLC recalls Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA"
C17AAG
C17AAGDec 13, 2017 - Use cautionMedical device
Covidien LLC recalls Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult
Covidien recalls rechargeable lithium-ion batteries used with Puritan Bennett 980 ventilators that may not fully charge due to incorrect firmware. Affected units have specific serial numbers listed in the recall notice.
CovidienNov 21, 2017 - Use cautionMedical device
Covidien LLC recalls Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton
Covidien recalls Situate Gauze RF and X-Ray detectable products due to potential failure to detect by the Situate console from a manufacturing error. Affected items have Product Number G0804-16P02CN-1 and Lot Number 170704A.
CovidienOct 12, 2017 - UnratedMedical device
Covidien LLC recalls GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in
Covidien recalls GastriSail gastric positioning devices due to reports of gastric or esophageal perforation during use in bariatric surgery. Affected models include GPS36 (pediatric) and GPS40 (adult) with specific lot codes.
CovidienSep 21, 2017 - Use cautionMedical device
Covidien LLC recalls Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have
Covidien recalls Endo GIA Radial Reload with Tri-Stap: Cartridge disengagement due to manufacturing error. Affected units have product number EGIARADXT and lot code N6L0351X.
CovidienSep 15, 2017 - Use cautionMedical device
Covidien LLC recalls Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic
Covidien recalls Endo GIA Auto Suture Universal Articulating Loading Units due to potential safety interlock failure, which could allow firing an empty unit twice during surgery.
CovidienSep 13, 2017 - Stop using nowMedical device
Covidien LLC recalls Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
Covidien recalls Emprint Percutaneous Antenna with Thermosphere Technology due to risk of ceramic tip disengaging post-ablation, potentially remaining in patient. Affected units have specific lot codes and UDI.
CovidienAug 7, 2017
Covidien LLC recall questions
How many recalls has Covidien LLC had?
152 recalls from Covidien LLC are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Covidien LLC recall?
Covidien, LLC recalls EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100, dated May 13, 2026. Every Covidien LLC recall is listed on this page, newest first.
Why are Covidien LLC products recalled?
The most common reasons on record: Temperature probe devices lack FDA clearance. (3).
What should I do if I have a recalled Covidien LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Covidien LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.