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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.

Integra LifeSciences

Class I - Dangerous

There is a potential for a progressive decline in observed ICP readings of the monitor during use.

Sep 12, 2019 Diagnostic Equipment View Details →

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 269 cm / 14 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.

ICU Medical

Class I - Dangerous

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Jul 29, 2019 Infusion Pumps Nationwide View Details →

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 unit per pouch; 48 pouches per case.

ICU Medical

Class I - Dangerous

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Jul 29, 2019 Infusion Pumps Nationwide View Details →

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.

ICU Medical

Class I - Dangerous

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Jul 29, 2019 Infusion Pumps Nationwide View Details →

Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.

Roche Diagnostics Operations

Class I - Dangerous

Due to low Quality Control recovery and invalid Calibration.

Sep 11, 2019 Diagnostic Equipment Nationwide View Details →

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the U.S.

ICU Medical

Class I - Dangerous

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Jul 29, 2019 Infusion Pumps Nationwide View Details →

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case

ICU Medical

Class I - Dangerous

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Jul 29, 2019 Infusion Pumps Nationwide View Details →

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filter in Sight Chamber, CLAVE Port, 0.2 Micron Filter, CLAVE Y-Site, PE Lined Light Resistant Tubing, Distal Microbore Tubing 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.

ICU Medical

Class I - Dangerous

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Jul 29, 2019 Infusion Pumps Nationwide View Details →

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case

ICU Medical

Class I - Dangerous

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Jul 29, 2019 Infusion Pumps Nationwide View Details →

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the U.S.

ICU Medical

Class I - Dangerous

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Jul 29, 2019 Infusion Pumps Nationwide View Details →

Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use

Vital Scientific N.V.

Class I - Dangerous

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Jan 10, 2012 Infusion Pumps Nationwide View Details →

OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032

OrthoPediatrics

Class I - Dangerous

Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures

Aug 19, 2019 Implants & Prosthetics Nationwide View Details →

Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X

Medtronic Vascular Galway

Class I - Dangerous

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

Sep 3, 2019 Surgical Instruments View Details →

Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

Vital Scientific N.V.

Class I - Dangerous

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Jan 10, 2012 Other Medical Devices Nationwide View Details →

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case

ICU Medical

Class I - Dangerous

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Jul 29, 2019 Infusion Pumps Nationwide View Details →

V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use

Vital Scientific N.V.

Class I - Dangerous

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Jan 10, 2012 Other Medical Devices Nationwide View Details →

Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.

Roche Diagnostics Operations

Class I - Dangerous

Due to low Quality Control recovery and invalid Calibration.

Sep 11, 2019 Diagnostic Equipment Nationwide View Details →

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case

ICU Medical

Class I - Dangerous

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Jul 29, 2019 Infusion Pumps Nationwide View Details →

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

ICU Medical

Class I - Dangerous

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Jul 29, 2019 Infusion Pumps Nationwide View Details →

Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

Vital Scientific N.V.

Class I - Dangerous

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Jan 10, 2012 Other Medical Devices Nationwide View Details →