Recall archive
64 recalls · page 2 of 3
Reported May 1, 2019
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Sterilization method used was not consistent with the labeling and the approved sterilization method
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2019
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
FDA (openFDA device enforcement)
Reported Dec 26, 2018
Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien LLC
Matched: Brand — Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 19, 2018
Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged…
FDA (openFDA device enforcement)
Reported Nov 21, 2018
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal…
FDA (openFDA device enforcement)
Reported Oct 10, 2018
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Potential for product sterility breach due to a compromised or pinched seal defect
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 26, 2018
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 5, 2018
Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
FDA (openFDA device enforcement)
Reported Aug 8, 2018
Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Potential proplylene glycol contamination
FDA (openFDA device enforcement)
Reported Jul 18, 2018
LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
FDA (openFDA device enforcement)
Reported May 2, 2018
EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 4, 2018
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 28, 2018
Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by…
FDA (openFDA device enforcement)
Reported Mar 14, 2018
Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — The device cartridge disengaged during use due to manufacturing error.
FDA (openFDA device enforcement)
Reported Feb 28, 2018
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2018
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2017
Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Cotton tip of the device may disengage due to insufficient adhesive
FDA (openFDA device enforcement)
Reported Apr 12, 2017
Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Product sterility is compromised due to breach of sterile barrier
6 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 15, 2017
Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Sterility compromised due to breach in sterile barrier
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2017
Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
FDA (openFDA device enforcement)
Reported Dec 21, 2016
Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Sterility of the outer surface of the container compromised due to packaging defect.
FDA (openFDA device enforcement)
Reported Nov 16, 2016
Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2016
Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Compromised sterility due to breach of barrier
12 more products in this recall
FDA (openFDA device enforcement)
Reported May 18, 2016
Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Potential of an allergic reaction in a patient with nickel sensitivity.
1 more product in this recall
FDA (openFDA device enforcement)
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