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High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·10 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·50 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·202 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·273 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·522 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Medical Devices·1,920 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·5 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·202 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·2,703 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise a...
Medical Devices·18 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·46 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·19 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·25 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Medical Devices·18 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·141 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·32 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·625 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·1,217 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for int...
Diagnostic Devices·867 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced ...
Medical Devices·4 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Medical Devices·2 affected·Jan 11, 2013
High RiskFDA
Codman & Shurtleff, Inc.
NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intr...
Diagnostic Devices·46 affected·Jan 11, 2013
High RiskFDA
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Medical Devices·3,324 affected·Jan 11, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating s...
Medical Devices·328 affected·Jan 11, 2013
High RiskFDA
Hospira, Inc.
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
Injectable Drugs·63,900 affected·Jan 10, 2013
High RiskFDA
Extremity Medical Llc
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained i...
Surgical Devices·238 affected·Jan 10, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of pineapple flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of blueberry flavored powder and sold under the Boba Direct, Inc. brand.
Produce·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of mango flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of vanilla flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of avocado flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of cherry flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of chocolate flavored powder and sold under the Boba Direct, Inc. brand.
Snacks & Candy·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of lychee flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of coconut flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of almond flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of strawberry flavored powder and sold under the Boba Direct, Inc. brand.
Produce·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of cafe latte flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of banana flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of red bean flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of passion fruit flavored powder and sold under the Boba Direct, Inc. brand.
Produce·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of watermelon flavored powder and sold under the Boba Direct, Inc. brand.
Beverages·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of peppermint flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Penzeys Ltd
Vietnamese Cinnamon Extra Fancy, product code 43200, Penzeys Spices, Wauwatosa, WI 53222. to be completed
Food·47 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of lavender flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of taro flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of green tea flavored powder and sold under the Boba Direct, Inc. brand.
Beverages·0 affected·Jan 9, 2013
High RiskFDA
Boba Direct, Inc.
Foil bags containing 2.2 lbs. each of honeydew flavored powder and sold under the Boba Direct, Inc. brand.
Food·0 affected·Jan 9, 2013