Zimmer, Inc. - CPT Hip System - Class 2 Recall
CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe...
View ArticleStryker Medical Division of Stryker Corporation - Secure II Med/Surg Bed -...
Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use...
View ArticleStryker Medical Division of Stryker Corporation - S3 Med/Surg Bed - Class 2...
S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and...
View ArticleMerit Medical Systems, Inc. - Maestro Microcatheter - Class 2 Recall
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the...
View ArticlePhilips Medical Systems, Inc. - Philips HeartStart MRx Monitor/Defibrillator...
Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for use for the termination of ventricular tachycardia and...
View ArticleSynthes USA HQ, Inc. - Synthes Hand Switch Electric Pen Drive - Class 2 Recall
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling,...
View ArticleSteris Corporation - SYSTEM 1E Liquid Chemical Sterilant Processing System -...
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical...
View ArticleGE Healthcare It - Centricity Laboratory System - Class 2 Recall
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical...
View ArticleCarestream Health Inc. - DRX Revolution Mobile Xray System - Class 2 Recall
Carestream DRX Revolution Mobile X-ray System The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of xrays for examination of various anatomical regions. These products...
View ArticleAesculap, Inc. - Aesculap HiLine XXS handpiece - Class 2 Recall
Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.
View ArticleTrans American Medical, Inc. - Spectre Wireless Footswitch/Handswitch system...
Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with...
View ArticleSpineFrontier, Inc. - PedFuse Bone Probe - Class 2 Recall
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
View ArticleMaterialise USA LLC - Signature - Class 2 Recall
REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The...
View ArticleSiemens Healthcare Diagnostics, Inc. - HbA1c Flex(R) reagent cartridge -...
HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R)...
View ArticleIntegra LifeSciences Corp. - Integra Small Rickham Style Reservoir - Class 2...
Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1121 Provides access to the lateral...
View ArticleSiemens Healthcare Diagnostics, Inc. - HB1C Flex(R) Reagent Cartridge - Class...
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R)...
View ArticleIntegra LifeSciences Corp. - Integra Large Rickham Style Reservoir - Class 2...
Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA NL 850-1132 Provides access to the lateral...
View ArticleRTI Surgical, Inc. - CPlus - Class 2 Recall
C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to...
View ArticleCovidien - Puritan Bennett 840 ventilator systems software - Class 1 Recall
Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
View ArticleThe Anspach Effort, Inc. - Anspach BLACKMAXN (Pneumatic motor) and Autolube...
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
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