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    ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FEB·September 11, 2008

    Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code KRR·July 30, 2014

    CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA. Private labeled for P.J. Dahlhausen in Germany. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.

    FDA Recall
    Terminated ·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008

    Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KRR·January 11, 2016

    Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model Description 2-8-001 HU ZERO CHANNEL NO LT 2-8-010 ASSY, HOOK-UP, OLYMPUS 2-8-014 HOOKUP, OPTIM LT 2-8-030 ASSY, HOOKUP, PENTAX-0K 2-8-040 ASSY, HKUP STORZ 0K 2-8-070 ASSY, HU VISION SCIENCE 2-8-112 ASSY, HOOKUP OLMPUS 1K 2-8-120 ASSY, HOOKUP FUJI 1K 2-8-210 ASSY, HOOK-UP OLYMPUS 2K 2-8-213 ASSY, HOOKUP, OLYMPUS-2K 2-8-218 ASSY HOOKUP OLY 2K 2-8-236 ASSY, HOOKUP FUJINON 2K 2-8-244 ASSY, HOOKUP, STORZ 2K 2-8-245 ASSY, HOOK-UP, STORZ 2K 2-8-246 ASSY, HKUP, PENTAX-2K 2-8-260 ASSY, HOOK-UP WOLF 2-K 2-8-280 ASSY HOOKUP 2-8-312 ASSY, HOOK-UP OLYMPUS-3K 2-8-330 ASSY, HOOK-UP, PENTAX-3K 2-8-332 ASSEMBLY, HOOK-UP, PENTAX 2-8-334 ASSEMBLY, HOOK-UP, PENTAX 2-8-335 ASSY, HOOKUP, OLYMPUS, 3K 2-8-336 ASSY,HKUP FUJI 70 BRONC 2-8-338 ASSY, HU, FUJI BRONCH U/S 2-8-421 ASSY, HOOKUP, FUJIFILM 2-8-428 ASSY, ED-580XX 2-8-431 ASSY, HOOKUP, PENTAX 2-8-432 ASSY, HOOK-UP, PENTAX 2-8-460 HOOKUP, ASSY WOLF 4K 2-8-511 ASSY, HOOK-UP, OLY 2-8-513 ASSY HOOKUP OLY 4K ESOPHA 2-8-522 ASSY, FUJINON 4K-JET 2-8-523 ASSY, HKUP, FUJI 4K SER 5 2-8-526 ASSY, HOOKUP FUJI 4K+JET 2-8-527 ASSY, FUJI 700 NO FWJ 2-8-528 HOOK, EI-580BT 2-8-534 ASSY, HOOK-UP, PEN-4K+JET 2-8-537 ASSY, HKUP, PTX90 4K+JET 2-8-539 HOOK, PTX I20 FWJ 2-8-540 ASSY-HOOK-UP,STORZ,5K 2-8-611 ASSY, HOOK-UP, OLY 2-8-612 ASSY, HOOKUP, PENTAX 2-8-614 ASM HU OLY TGF-UC180J 2-8-617 ASSY, HKUP, OLY 2 BIOPSY 2-8-623 ASSY,HKUP,FUJI-5 4K+JET 2-8-625 ASSY, HOOKUP, EG-580UT 2-8-626 ASSY, HOOKUP, EG-580UR 2-8-627 ASSY, HKUP, FUJI 700 SER 2-8-634 ASSY, HOOKUP PENTAX DUAL 2-8-639 HOOK, EG3X-J10 2-8-640 ASSY,HOOK-UP STORZ 6K 2-8-711 ASSY, HOOKUP, OLYMPUS 5K 2-8-718 ASSY, HOOKUP, OLY 160/180 2-8-740 ASSY, HOOK-UP, STORZ 2-8-811 ASSY HKUP OLY-ECHO+LIFT 2-8-901 KIT TEE/TOE/RUS HU ADV+ 5-8-010 ASSY, HOOKUP DBL LT 5-8-030 ASSY, HOOKUP 5-8-040 ASSY HOOKUP STORZ 0K DBL 5-8-050 ASSY, HOOKUP, DILATOR 5-8-112 HOOKUP 2-SCOPE 1-K 5-8-190 HOOK DBL, IS, ION 5-8-210 ASSY, HOOKUP 5-8-245 HOOKUP KARLSTORZ-2K 2-8-001HAN HU ZERO CHANNEL NO LT 2-8-002HAN ADVANTAGE TEST BLOCK 2-8-010HAN ASSEMBLY, HOOK-UP,OLYMPUS 2-8-030HAN ASSY,HOOKUP,PENTAX-OK 2-8-112HAN ASSY, HOOK-UP OLYMPUS 1K 2-8-160HAN ASSY, ADV HOOKUP, WOLF 2-8-210HAN ASSY, HOOK-UP OLYMPUS 2K 2-8-213HAN ASSY, HOOKUP, OLYMPUS-2K 2-8-218HAN ASSY HOOKUP OLY 2K 2-8-245HAN ASSY, HOOKUP, STORZ-2K 2-8-330HAN ASSY, HOOK-UP, PENTAX-3K 2-8-334HAN ASSEMBLY, HOOK-UP, PENTAX 2-8-335HAN ASSY,HOOKUP,OLYMPUS 2-8-336HAN ASSY,HKUP FUJI 70 BRONC 2-8-338HAN ASSY, HU, FUJI BRONCH U/S 2-8-421HAN ASSY, HOOKUP, FUJINON 2-8-428CAS HOOK, CAS, ED-580XX 2-8-428HAN HOOK, HAN, ED-580XX 2-8-431CAS ASSY, CASSETTE, PENTAX 2-8-431HAN ASSY, HOOK-UP, PENTAX 2-8-511HAN ASSY, HOOK-UP, OLY 2-8-526HAN ASSY, HOOKUP FUJI 4K+JET 2-8-536HAN HOOKUP,PENTAX,70ULT, 5K 2-8-537CAS ASSY,CASS,PTX 90 4K+JET 2-8-537HAN ASSY HKUP,PTX90 4K+JET 2-8-611HAN ASSY, HOOK-UP, OLY 2-8-626CAS ASSY, CASS, FUJINON 580UR 2-8-627HAN ASSY, HAN, FUJI 700 SER 2-8-634CAS ASSY,CASS PENTAX DUAL CH 2-8-634HAN ASSY,HOOKUP PENTAX DUAL 2-8-640HAN ASSY, HOOK-UP STORZ 6K 2-8-711HAN ASSY, HOOKUP, OLYMPUS-5K 2-8-718HAN ASSY,HOOK-UP, OLY 160/180 2-8-811HAN ASSY HKUP OLY-ECHO W/LIFT 2-8-902H HU BLOCK ULTRASOUND PROBE 5-8-030HAN ASSY, HOOKUP 5-8-050HAN ASSY,HOOKUP, DILATOR 5-8-112HAN ASSY, HOOKUP 2-SCOPE 1-K 5-8-244HAN ASSY, HKUP 2K DBL

    FDA Recall
    Open, Classified ·Steris Corporation·Product code FEB·November 13, 2023

    (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code HRY·December 21, 2017

    Equator Forced Air Convective Warming System, Reference Number EQ 5000

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code DWJ·December 15, 2004

    Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with either Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505, 750 and 775 Indicated for hyper- or hypothermic patients or normothermic patients, for whom induced hyper- hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.

    FDA Recall
    Terminated ·Arizant Inc·Product code DWJ·December 17, 2009

    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·September 3, 2013

    Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

    FDA Recall
    Open, Classified ·Medivance Inc.·Product code DWJ·February 16, 2024

    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code FWJ·May 23, 2024

    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.

    FDA Recall
    Terminated ·Bard Medical Division·Product code DWJ·November 8, 2017

    Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code DWJ·July 2, 2019

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

    FDA Recall
    Completed ·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022

    SonaMed Clarity System II; evoked response auditory stimulator; SonaMed Corp., Waltham, MA 02154

    FDA Recall
    Terminated ·Natus Medical Inc·Product code GWJ·June 4, 2010

    Electri-Cord Manufacturing Corporation (312 E. Main St., Westfield, PA 16950) AC power cords used with Ranger Irrigation Fluid Warming Unit; Model 247. Intended to warm irrigation fluids.

    FDA Recall
    Terminated ·Arizant Inc·Product code DWJ·December 17, 2009

    WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convective heat transfer from the controller to a warm-air heated blanket

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·June 1, 2011

    115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·October 18, 2010

    MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code DWJ·July 21, 2017

    Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.

    FDA Recall
    Terminated ·C.R. Bard, Inc.·Product code DWJ·June 30, 2016