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High RiskFDA
Ge Healthcare, Llc
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained h...
Medical Devices·11 affected·Mar 20, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR...
Medical Devices·120 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detect...
Medical Devices·35 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medici...
Medical Devices·37 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of rad...
Medical Devices·6 affected·Mar 20, 2019
High RiskFDA
Ge Healthcare, Llc
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radiois...
Medical Devices·31 affected·Mar 20, 2019
RecallFDA
Merical, Llc
Walgreens Probiotic 12.5 Billion Active Cultures, 30 capsules; Dietary Supplement. Probiotic Blend 12.5 Billion CFU's L. rhamnosus H...
Produce·323 affected·Mar 19, 2019
High RiskFDA
Lupin Somerset
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Labora...
Oral Drugs·76,422 affected·Mar 19, 2019
High RiskFDA
Allergan Sales, Llc
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S...
Ophthalmic Drugs·72 affected·Mar 19, 2019
High RiskFDA
Carestream Health, Inc.
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Conso...
Medical Devices·37 affected·Mar 19, 2019
RecallFDA
Aniara Diagnostica Llc
BIOPHEN UFH Control C1, REF 224101
Medical Devices·41 affected·Mar 19, 2019
RecallFDA
Aniara Diagnostica Llc
BIOPHEN LMWH Control C4, REF 224201
Medical Devices·3 affected·Mar 19, 2019
RecallFDA
Aniara Diagnostica Llc
BIOPHEN UFH Control C2, REF 223901
Medical Devices·14 affected·Mar 19, 2019
CriticalFDA
Almark Foods Inc
Nic's Peeled Pearls 20lb. Salad Grade Hard-Boiled Eggs NET WT. WHEN PACKED 20lbs Manufactured By: Almark Foods Gainesville, GA 30504 1.80...
Produce·43 affected·Mar 18, 2019
High RiskFDA
Union Fish Company
Vega White Headless Shrimp, 21/15 and 26/30 count size. Frozen block in plastic bag, 6 x 4 lbs. per master carton. Product of the Phi...
Seafood·2,400 affected·Mar 18, 2019
RecallFDA
Ingenus Pharmaceuticals Llc
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando...
Topical Drugs·29,435 affected·Mar 18, 2019
High RiskFDA
Ideal Implant Incorporated
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc...
Medical Implants·1,704 affected·Mar 18, 2019
High RiskFDA
Opgen Inc
CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic T...
Diagnostic Devices·80 affected·Mar 18, 2019
RecallFDA
Advanced Bionics, Llc
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Medical Implants·4 affected·Mar 18, 2019
RecallFDA
Pfizer Inc.
Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Divisi...
Injectable Drugs·500 affected·Mar 15, 2019
CriticalFDA
Pfizer Inc.
8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx onl...
Injectable Drugs·283,400 affected·Mar 15, 2019
RecallFDA
Pfizer Inc.
Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 4...
Injectable Drugs·8,878 affected·Mar 15, 2019
RecallFDA
Estee Lauder Inc
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL silver jar...
Topical Drugs·14,490 affected·Mar 15, 2019
RecallFDA
Pfizer Inc.
Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 477...
Injectable Drugs·8,320 affected·Mar 15, 2019
RecallFDA
Pfizer Inc.
Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 4...
Injectable Drugs·701 affected·Mar 15, 2019
RecallFDA
Pfizer Inc.
Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Divisi...
Injectable Drugs·820 affected·Mar 15, 2019
RecallFDA
Pfizer Inc.
Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Divis...
Injectable Drugs·67 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL1.0, .070", REF SA6AL10. for cardiovascular use
Surgical Devices·3,302 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F JL3.0 SH, .070", REF SA6JL30SH. for cardiovascular use
Surgical Devices·49 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular use
Surgical Devices·538 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD RIGHT SHORT TIP, .070", REF SA6ERADRST. for cardiovascular use
Surgical Devices·18 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.5, .070", REF SA6SL45. for cardiovascular use
Surgical Devices·25 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardiovascular use
Surgical Devices·1,364 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB 90CM, .070", REF SA6LCBD. for cardiovascular use
Surgical Devices·3 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular use
Surgical Devices·3 affected·Mar 15, 2019
High RiskFDA
Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer
Diagnostic Devices·149 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardiovascular use
Surgical Devices·23 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070", REF SA6CHAMP20SH. for cardiovascular use
Surgical Devices·9 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular use
Surgical Devices·1,479 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.0 SH, .070", REF SA6EBU40SH. for cardiovascular use
Surgical Devices·303 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F LARA, .070", REF SA6LARA. for cardiovascular use
Surgical Devices·247 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F SL4.0, .070", REF SA6SL40. for cardiovascular use
Surgical Devices·531 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular use
Surgical Devices·658 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP1.0 SH, .070", REF SA6CHAMP10SH. for cardiovascular use
Surgical Devices·10 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL.75, .070", REF SA6SAL75. for cardiovascular use
Surgical Devices·33 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for cardiovascular use
Surgical Devices·614 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovascular use
Surgical Devices·5 affected·Mar 15, 2019
CriticalFDA
Medtronic Vascular
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL3.0, .070", REF SA6AL30. for cardiovascular use
Surgical Devices·219 affected·Mar 15, 2019