Recall archive
64 recalls · page 1 of 3
Reported Jul 8, 2026
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
FDA (openFDA device enforcement)
Reported Jun 10, 2026
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Due to customer complaint regarding incorrect display box labeling.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 18, 2026
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on…
FDA (openFDA device enforcement)
Reported Sep 28, 2022
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by…
FDA (openFDA device enforcement)
Reported Aug 3, 2022
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot…
FDA (openFDA device enforcement)
Reported Jul 13, 2022
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien LLC
Matched: Brand — 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…
8 more products in this recall
FDA (openFDA device enforcement)
Reported 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;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g.,…
FDA (openFDA device enforcement)
Reported Jan 19, 2022
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential…
FDA (openFDA device enforcement)
Reported Dec 15, 2021
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 17, 2021
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary…
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may…
FDA (openFDA device enforcement)
Reported Apr 21, 2021
Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an…
FDA (openFDA device enforcement)
Reported Apr 7, 2021
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 3, 2021
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is…
FDA (openFDA device enforcement)
Reported Jan 6, 2021
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 9, 2020
Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message,…
FDA (openFDA device enforcement)
Reported Nov 18, 2020
Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or…
FDA (openFDA device enforcement)
Reported Aug 12, 2020
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2020
Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when…
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2020
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure…
10 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 11, 2020
Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2020
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for…
27 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2019
MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to…
FDA (openFDA device enforcement)
Reported Jun 26, 2019
EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may…
11 more products in this recall
FDA (openFDA device enforcement)
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