Covidien LP

Complete recall history across all FDA and CPSC categories — 57 total recalls

Covidien LP 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 (57)

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

Date Product Reason Class
Sep 19, 2024 Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH0... Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house b... Class II
Mar 15, 2024 Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Sym... Products may not be heparin coated as indicated on the label-leads to a poten... Class II
Mar 15, 2024 Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 1... Products may not be heparin coated as indicated on the label-leads to a poten... Class II
Dec 21, 2023 Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 ... Specific lots of sutures were sterilized with gamma doses that exceeded the r... Class II
Dec 21, 2023 Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 8... Specific lots of sutures were sterilized with gamma doses that exceeded the r... Class II
Nov 16, 2023 AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -int... Packaging of the device may cause a low seal strength in the side seal of the... Class II
Aug 22, 2023 Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm Some catheter kits labeled as 23 cm implant length incorrectly included cathe... Class II
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensio... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensio... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extension... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the cathet... Class I
Mar 22, 2023 VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS There is a manufacturing non-conformance that may result in a metal shaving (... Class II
Mar 22, 2023 VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS There is a manufacturing non-conformance that may result in a metal shaving (... Class II
Mar 22, 2023 VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS There is a manufacturing non-conformance that may result in a metal shaving (... Class II
Dec 7, 2022 MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single... There is a potential leaking condition within the hub of affected devices, du... Class I
Jul 17, 2017 Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Spon... Medtronic is voluntarily recalling two production lots of its Covidien Vistec... Class II
May 6, 2013 Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST ... Seals may disengage from the cannula which may result in a component inadvert... Class II
May 6, 2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code:... Seals may disengage from the cannula which may result in a component inadvert... Class II
May 6, 2013 Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONB... Seals may disengage from the cannula which may result in a component inadvert... Class II
May 6, 2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Produ... Seals may disengage from the cannula which may result in a component inadvert... Class II
May 6, 2013 Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Produc... Seals may disengage from the cannula which may result in a component inadvert... Class II
May 6, 2013 Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product... Seals may disengage from the cannula which may result in a component inadvert... Class II
Feb 11, 2013 Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm ... Single Use Loading Unit contained two staples loaded in each cartridge pocket... Class II
Aug 21, 2012 Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Prod... Duet TRS may have the potential to injure adjacent anatomical structures whic... Class II
Aug 21, 2012 Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Prod... Duet TRS may have the potential to injure adjacent anatomical structures whic... Class II
Aug 21, 2012 Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Produ... Duet TRS may have the potential to injure adjacent anatomical structures whic... Class II
Aug 21, 2012 Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. ... Duet TRS may have the potential to injure adjacent anatomical structures whic... Class II
Aug 21, 2012 Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. ... Duet TRS may have the potential to injure adjacent anatomical structures whic... Class II
Aug 21, 2012 Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Prod... Duet TRS may have the potential to injure adjacent anatomical structures whic... Class II

View all 57 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.

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