🔍 RecallPedia

All Recalls

95,094 total recalls in our database

🍎
28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,647
Consumer Products

Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Mar 17, 2016 Other Medical Devices Nationwide View Details →

Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Mar 17, 2016 Other Medical Devices Nationwide View Details →

GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.

Baxter Healthcare

🏥 Medical Devices Class I - Dangerous

Instructions for use booklet may puncture the outer Tyvek lid.

Apr 21, 2016 Implants & Prosthetics Nationwide View Details →

Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Mar 17, 2016 Other Medical Devices Nationwide View Details →

Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of 20 hours. Testing using reagent at the end of the 20 hours On-Board Stability has shown that values of methotrexate for patient and quality control samples increased.

Mar 8, 2016 Infusion Pumps View Details →

Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature

C.R. Bard

🏥 Medical Devices Class I - Dangerous

The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.

Nov 9, 2015 Diagnostic Equipment Nationwide View Details →

Dimension Vista Assays: Enzymatic Creatine (ECRE)

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Mar 17, 2016 Other Medical Devices Nationwide View Details →

CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.

Stryker

🏥 Medical Devices Class I - Dangerous

Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking upon deployment of the anchor.

Apr 12, 2016 Implants & Prosthetics Nationwide View Details →

Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.

Bradshaw Medical

🏥 Medical Devices Class I - Dangerous

A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.

Feb 2, 2015 Surgical Instruments Nationwide View Details →

Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.

Hamilton Medical

🏥 Medical Devices Class I - Dangerous

After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.

Mar 9, 2016 Patient Monitors View Details →

Advia Chemistry Assay: Lactate

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Mar 17, 2016 Other Medical Devices Nationwide View Details →

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

Biomerieux

🏥 Medical Devices Class I - Dangerous

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Feb 24, 2016 Diagnostic Equipment View Details →

ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.

Mar 30, 2016 Diagnostic Equipment Nationwide View Details →

Dimension Assays: Uric Acid (URCA)

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Mar 17, 2016 Other Medical Devices Nationwide View Details →

Advia Chemistry Assay: LDL Cholesterol, Direct

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

Mar 17, 2016 Other Medical Devices Nationwide View Details →