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High RiskFDA
Zimmer, Inc.
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203...
Medical Implants·231,641 affected·Apr 1, 2011
High RiskFDA
Zimmer, Inc.
00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803...
Medical Implants·231,641 affected·Apr 1, 2011
High RiskFDA
Zimmer, Inc.
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 M...
Medical Implants·231 affected·Apr 1, 2011
High RiskFDA
Zimmer, Inc.
00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral He...
Medical Implants·231 affected·Apr 1, 2011
High RiskFDA
The Anspach Effort, Inc.
AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting b...
Medical Devices·599 affected·Mar 31, 2011
High RiskFDA
The Anspach Effort, Inc.
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Medical Devices·29 affected·Mar 31, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW Volume...
Medical Devices·283 affected·Mar 25, 2011
High RiskFDA
Physicians Total Care, Inc.
Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC...
Oral Drugs·60 affected·Mar 18, 2011
High RiskFDA
Hospira Inc.
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira ret...
Medical Devices·10,897 affected·Mar 16, 2011
High RiskFDA
Hospira Inc.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira ret...
Medical Devices·10,337 affected·Mar 16, 2011
High RiskFDA
Luitpold Pharmaceuticals, Inc.
CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC ...
Injectable Drugs·30 affected·Mar 15, 2011
High RiskFDA
The Anspach Effort, Inc.
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Medical Devices·1,827 affected·Mar 4, 2011
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images o...
Medical Devices·1,765 affected·Mar 3, 2011
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System ...
Medical Devices·16,579 affected·Mar 1, 2011
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replace...
Medical Devices·165 affected·Mar 1, 2011
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is...
Medical Devices·596 affected·Mar 1, 2011
High RiskFDA
Ron's Pizza Warehouse
The pizza dough shells come in 5 lb. brown cardboard boxes, containing 25 shells per box.
Food·700 affected·Feb 11, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluorosco...
Medical Devices·48 affected·Feb 4, 2011
High RiskFDA
Cordis Corporation
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688...
Surgical Devices·1 affected·Jan 31, 2011
High RiskFDA
Westmed Inc
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part n...
Medical Devices·1,259,200 affected·Jan 18, 2011
High RiskFDA
Westmed Inc
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1", 25U Balanced Heparin, part number: 3362-95....
Medical Devices·1,259,200 affected·Jan 18, 2011
High RiskFDA
Westmed Inc
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, Luer Slip Barrel, 25U Balanc...
Medical Devices·1,259,200 affected·Jan 18, 2011
High RiskFDA
Westmed Inc
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number:...
Medical Devices·1,259,200 affected·Jan 18, 2011
High RiskFDA
Westmed Inc
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part n...
Medical Devices·1,259,200 affected·Jan 18, 2011
High RiskFDA
Westmed Inc
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, No B Nee...
Medical Devices·1,259,200 affected·Jan 18, 2011
High RiskFDA
Westmed Inc
Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 22 g x 1" A/B Needle, 25U Balanced Heparin, part number: 3372. ...
Medical Devices·1,259,200 affected·Jan 18, 2011
High RiskFDA
Westmed Inc
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part num...
Medical Devices·1,259,200 affected·Jan 18, 2011
High RiskFDA
Nemschoff Chairs, Inc.
Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to p...
Medical Devices·1,868 affected·Jan 18, 2011
High RiskFDA
Westmed Inc
Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part num...
Medical Devices·1,259,200 affected·Jan 18, 2011
High RiskFDA
Pentax Of America Inc
Video Cytoscopes
Medical Devices·1,349 affected·Jan 11, 2011
High RiskFDA
Sterigear, Llc
SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1...
Surgical Devices·110,560 affected·Jan 11, 2011
High RiskFDA
Abbott Point Of Care Inc.
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure ...
Respiratory Devices·52,750 affected·Jan 1, 2011
High RiskFDA
Philips Electronics North America Corporation
M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, ...
Medical Devices·607 affected·Dec 17, 2010
High RiskFDA
Super Mom's
Country Fresh Ovens Cheese Coffee Cake, Net Wt 5 oz (142g). Dist. by Country Fresh Ovens, St. Paul Park, MN 55071
Dairy·0 affected·Dec 8, 2010
High RiskFDA
Pride Mobility Products Corp
Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.
Medical Devices·186 affected·Nov 26, 2010
High RiskFDA
Canon Inc.
Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices ar...
Diagnostic Devices·468 affected·Nov 1, 2010
High RiskFDA
Zimmer, Inc.
00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral He...
Medical Implants·128,946 affected·Oct 10, 2010
High RiskFDA
Zimmer, Inc.
00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203...
Medical Implants·56,516 affected·Oct 10, 2010
High RiskFDA
Zimmer, Inc.
00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003...
Medical Implants·56,516 affected·Oct 10, 2010
High RiskFDA
Zimmer, Inc.
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 M...
Medical Implants·56,516 affected·Oct 10, 2010
High RiskFDA
Zimmer, Inc.
00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603...
Medical Implants·56,516 affected·Oct 10, 2010
High RiskFDA
Zimmer, Inc.
. 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral ...
Medical Implants·128,946 affected·Oct 10, 2010
High RiskFDA
Zimmer, Inc.
00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803...
Medical Implants·56,516 affected·Oct 10, 2010
High RiskFDA
Zimmer, Inc.
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603...
Medical Implants·56,516 affected·Oct 10, 2010
High RiskFDA
Sunquest Information Systems, Inc.
Sunquest Laboratory LabAccess Results Workstation (LARS)
Medical Devices·151 affected·Oct 5, 2010
High RiskFDA
Physicians Total Care, Inc.
Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Car...
Injectable Drugs·20 affected·Oct 4, 2010
High RiskFDA
Medtronic Xomed, Inc.
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box ...
Medical Devices·53 affected·Sep 27, 2010
High RiskFDA
Medtronic Xomed, Inc.
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box La...
Medical Devices·464 affected·Sep 27, 2010