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High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as P...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product la...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS 5.5 x 05mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product la...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MIS Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Ch...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Poly Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product la...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Tapper 5.5. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pa...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, ...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Small Crosslink. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled ...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Poly Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product la...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product lab...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MIS Screw 5.5 x 40mm and 5.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Ch...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Marking Pin (Smooth). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product lab...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Inside Bender (L) and (R). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Produc...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product l...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Poly Screw 7.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product la...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS 60mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labele...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Rod Checker and T-Bar. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product la...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Anti Torque Device. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product label...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MIS Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product lab...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product l...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M ...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
B. Braun Medical, Inc.
PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesth...
Medical Devices·700 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm and 6.5 x 4.5 screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chica...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pal...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product la...
Surgical Devices·2,225 affected·Jun 21, 2017
High RiskFDA
Valorem Surgical Llc
PALLAS M/MAXIMIS Extension Block. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled ...
Surgical Devices·262 affected·Jun 21, 2017
High RiskFDA
Penobscot Mccrum Llc
Battered Jo-Jo Wedges / 00047 (5 lb bags)
Food·31,956 affected·Jun 20, 2017
High RiskFDA
Penobscot Mccrum Llc
Sysco X-Large Jo-Jo Wedges / 7641749 (5 lb bags)
Food·7,307 affected·Jun 20, 2017
High RiskFDA
Penobscot Mccrum Llc
Valero Baby Wedges with Crisp Coat UC Coating / 51049 (5 lb bags)
Baby Food & Formula·5,924 affected·Jun 20, 2017
High RiskFDA
Penobscot Mccrum Llc
Medium Coated Jo-Jo Wedges / 00040 (5lb bags)
Food·951 affected·Jun 20, 2017
High RiskFDA
Penobscot Mccrum Llc
Medium Battered Jo-Jo Wedges / 00126 (5 lb bags)
Food·4,897 affected·Jun 20, 2017
High RiskFDA
Penobscot Mccrum Llc
Seasoned/Battered Baby Jo-Jo Wedges / 00049 (5 lb bags)
Baby Food & Formula·18,799 affected·Jun 20, 2017
High RiskFDA
Penobscot Mccrum Llc
Extra Large Seasoned/Battered Jo-Jo Wedges / 00148 (5 lb bags)
Food·336 affected·Jun 20, 2017
High RiskFDA
Penobscot Mccrum Llc
Medium Seasoned/Battered Jo-Jo Wedges / 00129 (5 lb bags)
Food·5,782 affected·Jun 20, 2017
High RiskFDA
Penobscot Mccrum Llc
Broaster Recipe Crinkle Cut Seasoned Wedges / 96698 (5 lb bags)
Food·21,560 affected·Jun 20, 2017
High RiskFDA
Penobscot Mccrum Llc
Extra Large Coated Jo-Jo Wedges / 00048 (5 lb bags)
Food·1,875 affected·Jun 20, 2017
High RiskFDA
Keystone Dental Inc
Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully ...
Medical Implants·20 affected·Jun 20, 2017
High RiskFDA
Apace Ky Llc
Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 ---...
Oral Drugs·1,483 affected·Jun 19, 2017
High RiskFDA
Fagron Compounding Services Llc Dba Fagron Sterile Services
Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC...
Injectable Drugs·1,056 affected·Jun 19, 2017
High RiskFDA
Apace Ky Llc
Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 ---...
Oral Drugs·0 affected·Jun 19, 2017
High RiskFDA
Conmed Corporation
STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT...
Surgical Devices·1,612,440 affected·Jun 19, 2017
High RiskFDA
Leica Microsystems, Inc.
Nussloch GmbH ASP6025 Tissue Processor
Medical Devices·812 affected·Jun 19, 2017
High RiskFDA
New Hope Mills Mfg., Inc.
Cost Plus World Market My Favorite Macadamia Pancake and Waffle Mix, 24 oz. UPC Codes: 496960
Bakery & Grains·1,272 affected·Jun 16, 2017
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmin...
Oral Drugs·1,980 affected·Jun 16, 2017
High RiskFDA
Alvogen, Inc
Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Broo...
Injectable Drugs·72,575 affected·Jun 16, 2017
High RiskFDA
Alvogen, Inc
Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Broo...
Injectable Drugs·5,100 affected·Jun 16, 2017