🔍 RecallPedia

All Recalls

95,114 total recalls in our database

🍎
28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,667
Consumer Products

STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Advanced Sterilization Products

🏥 Medical Devices Class I - Dangerous

Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.

Nov 4, 2014 Infusion Pumps View Details →

Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

Cyberonics

🏥 Medical Devices Class I - Dangerous

The recalled product was distributed with an incorrect serial number printed on the device's label.

Nov 20, 2014 Implants & Prosthetics View Details →

ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.

Heart Sync

🏥 Medical Devices Class I - Dangerous

Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the

Nov 11, 2014 Diagnostic Equipment Nationwide View Details →

VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Ortho-Clinical Diagnostics

🏥 Medical Devices Class I - Dangerous

Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.

Nov 6, 2014 Diagnostic Equipment Nationwide View Details →

Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC) results from an ABX Micros 60 Hematology Analyzer or ABX Micros CRP 200 Hematology Analyzer. Only one instrument connection is allowed per each Lite DM workstation. The Lite DM application runs on a PC within a Windows Operating System platform. Data transmitted from the instrument to the Lite DM workstation is a Serial RS-232 unidirectional ABX Format communication. The Lite DM can act as a standalone data manager for data received from the instrument, or allow transmission of this data to a Host (LIS  Laboratory Information System or EMR  Electronic Medical Record system). Following the completion of each blood sample analysis performed on the connected HORIBA Medical hematology analyzer, results are then communicated (uni-directional) to the Lite DM workstation. Results received will display to the user in a specific color coding format indicating any normal or panic reference range violations. Results are then rejected or accepted by the user for final reporting - formatted to guidelines stipulated by CLIA. At no time are any results interpreted; only reported for review and appropriate action.

Horiba Instruments

🏥 Medical Devices Class I - Dangerous

HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to the wrong order in the Lite DM Worklist. This bug has not been seen in software versions above V2.0.0.19 IMPACT: Potential for results received being applied to the wrong order in the Lite DM Worklist. The is

Nov 19, 2014 Surgical Instruments Nationwide View Details →

RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.

Iris Diagnostics

🏥 Medical Devices Class I - Dangerous

Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time.

Dec 3, 2014 Diagnostic Equipment Nationwide View Details →

HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

Instrumentation Laboratory

🏥 Medical Devices Class I - Dangerous

Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times.

Nov 21, 2014 Diagnostic Equipment Nationwide View Details →

ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring, Single use.

Heart Sync

🏥 Medical Devices Class I - Dangerous

Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the

Nov 11, 2014 Diagnostic Equipment Nationwide View Details →

STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Advanced Sterilization Products

🏥 Medical Devices Class I - Dangerous

Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.

Nov 4, 2014 Infusion Pumps View Details →

Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have with the Centricity Enterprise archive. The intended users for Centricity Enterprise Archive are service personnel and system administrators and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-1 profiles (published by IHE).

Ge Healthcare It

🏥 Medical Devices Class I - Dangerous

GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full.

Apr 19, 2013 Infusion Pumps Nationwide View Details →

STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Advanced Sterilization Products

🏥 Medical Devices Class I - Dangerous

Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.

Nov 4, 2014 Infusion Pumps View Details →

Tealight Wax Warmer sets

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

The tealights in the warmers can burn with an erratic or high flame, posing fire and burn hazards.

Dec 30, 2014 Clothing & Accessories Nationwide View Details →

Lg. Fruit Crostata, 21 oz., UPC 20829300000; Sm. Fruit Crostata, 7 oz., UPC 20829900000; Lg. Nectarine Crostata, 21 oz., UPC 20823100000; Sm. Nectarine Crostata, 6 oz., UPC 20832600000

Wegmans Food Markets

🍎 Food Class I - Dangerous

Wegmans Food Markets, Inc. voluntarily recalled fresh individually sold, bagged and sliced fresh plums, nectarines and peaches, peach salsa and several in-store baked desserts that may contain fresh peaches, nectarines, and/or plums. The fruit may be contaminated with Listeria monocytogenes.

Jul 20, 2014 Produce View Details →