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High RiskFDA
Polymer Technology Systems, Inc.
CHOL+HDL+GLU test strips, REF 2412
Medical Devices·67,643 affected·Jan 16, 2019
High RiskFDA
Polymer Technology Systems, Inc.
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Medical Devices·67,643 affected·Jan 16, 2019
High RiskFDA
Tris Pharma Inc.
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle...
Oral Drugs·35,328 affected·Jan 15, 2019
High RiskFDA
Tris Pharma Inc.
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ...
Oral Drugs·35,280 affected·Jan 15, 2019
High RiskFDA
Tris Pharma Inc.
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL ...
Oral Drugs·46,080 affected·Jan 15, 2019
High RiskFDA
Lupin Somerset
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD...
Topical Drugs·24,180 affected·Jan 15, 2019
High RiskFDA
Advanced Pharma Inc.
HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single use syr...
Injectable Drugs·160 affected·Jan 15, 2019
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9...
Oral Drugs·118 affected·Jan 15, 2019
High RiskFDA
Westmed, Inc.
Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID con...
Medical Devices·35 affected·Jan 15, 2019
High RiskFDA
Miami Device Solutions, Llc.
Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, a...
Medical Implants·15 affected·Jan 15, 2019
High RiskFDA
Westmed, Inc.
Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, ...
Medical Devices·625 affected·Jan 15, 2019
High RiskFDA
Century Snacks Llc
Snak Club Praline Pecans Made With Cane Sugar NET Wt. 2.25 oz (64 g) Produced By: Century Snack Commerce, CA 90040 centurysnacks.com
Snacks & Candy·25 affected·Jan 14, 2019
High RiskFDA
Shimadzu Medical Systems Usa Com
BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the hear...
Cardiac Devices·8 affected·Jan 14, 2019
High RiskFDA
Arthrex, Inc.
Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in bot...
Medical Devices·2,324 affected·Jan 14, 2019
High RiskFDA
Shimadzu Medical Systems Usa Com
TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, pe...
Cardiac Devices·13 affected·Jan 14, 2019
High RiskFDA
Becton Dickinson & Co.
BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacteria...
Diagnostic Devices·1,583 affected·Jan 14, 2019
High RiskFDA
Nutrafuels, Inc.
CTFO Pain Relief Oral Spray with pure CBD Hemp Oil isolate Dietary Supplement, 1oz/30ml.
Supplements·840 affected·Jan 11, 2019
High RiskFDA
Nutrafuels, Inc.
CTFO Sleep Support Oral Spray with pure CBD Hemp Oil isolate Dietary Supplement, 1oz/30ml.
Supplements·676 affected·Jan 11, 2019
High RiskFDA
Nutrafuels, Inc.
CTFO Weight Loss Oral Spray with pure CBD Hemp Oil isolate Dietary Supplement, 1oz/30ml.
Supplements·1,011 affected·Jan 11, 2019
High RiskFDA
Aap Implantate Ag
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of b...
Medical Implants·25 affected·Jan 11, 2019
High RiskFDA
Major Pharmaceuticals
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17...
Oral Drugs·3,102 affected·Jan 10, 2019
High RiskFDA
Mcguff Compounding Pharmacy Services, Inc.
Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGu...
Injectable Drugs·146 affected·Jan 10, 2019
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quant...
Diagnostic Devices·304 affected·Jan 10, 2019
High RiskFDA
Ottobock Orthopedic Industrie
21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. Th...
Medical Implants·110 affected·Jan 10, 2019
High RiskFDA
Ottobock Orthopedic Industrie
21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees....
Medical Implants·538 affected·Jan 10, 2019
High RiskFDA
Bio-rad Laboratories, Inc
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Medical Devices·213 affected·Jan 10, 2019
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitat...
Diagnostic Devices·31 affected·Jan 10, 2019
High RiskFDA
Perkinelmer Life And Analytical Sciences, Wallac, Oy
AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quant...
Diagnostic Devices·79 affected·Jan 10, 2019
High RiskFDA
Arrow International Inc
Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
Surgical Devices·45 affected·Jan 10, 2019
High RiskFDA
Lupin Pharmaceuticals Inc.
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufacture...
Oral Drugs·14,400 affected·Jan 9, 2019
High RiskFDA
Philips North America, Llc
PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pe...
Medical Devices·15,064 affected·Jan 9, 2019
High RiskFDA
Convatec, Inc
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary ...
Surgical Devices·5,744,525 affected·Jan 9, 2019
High RiskFDA
Philips North America, Llc
PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pe...
Medical Devices·11,332 affected·Jan 9, 2019
High RiskFDA
Convatec, Inc
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duo...
Medical Devices·1,231,155 affected·Jan 9, 2019
High RiskFDA
Neusoft Medical Systems Imp & Ex
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be u...
Medical Devices·3 affected·Jan 9, 2019
High RiskFDA
Lupin Pharmaceuticals Inc.
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Ma...
Oral Drugs·7,215 affected·Jan 7, 2019
High RiskFDA
Linet Spol. S.r.o.
AVE 2 Birthing Bed
Medical Devices·253 affected·Jan 7, 2019
High RiskFDA
Acuity Surgical Devices, Llc
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Op...
Medical Implants·27 affected·Jan 7, 2019
High RiskFDA
Smith & Nephew, Inc.
SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
Medical Devices·72 affected·Jan 7, 2019
High RiskFDA
Acuity Surgical Devices, Llc
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-...
Medical Implants·27 affected·Jan 7, 2019
High RiskFDA
Teleflex Medical
Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
Medical Devices·80 affected·Jan 7, 2019
High RiskFDA
Ardent Mills, Llc
MEMBERS MARK SELF RISE FLR 25LB
Food·0 affected·Jan 4, 2019
High RiskFDA
Grand Strand Sandwich Company,inc.
LUNCH BOX SANDWICHES HAM & CHEESE CROISSANT; NET WT 5OZ (142G); MADE BY: GS Sandwich Co. Longs, SC 29568 843.399.2999; UPC 0 67062 21217 2
Dairy·140 affected·Jan 4, 2019
High RiskFDA
Ardent Mills, Llc
WESTCREEK H&R SELF RISE AP FLR 25LB and 50LB
Food·0 affected·Jan 4, 2019
High RiskFDA
Ardent Mills, Llc
HILLTOP HEARTH SELF RISE FLR 25LB and 50LB
Food·0 affected·Jan 4, 2019
High RiskFDA
Ardent Mills, Llc
ARDENT H&R SR FLR, 25LB, 50 LB, and 25LB (PC)-309951, packaged in paper bags, Store at Ambient Temperature
Food·2,488 affected·Jan 4, 2019
High RiskFDA
Grand Strand Sandwich Company,inc.
LUNCH BOX SANDWICHES HAM & CHEESE; NET WT 4.5 OZ (127G); MADE BY: GS Sandwich Co. Longs, SC 29568 843.399.2999; UPC 0 67068 12110 8
Dairy·420 affected·Jan 4, 2019
High RiskFDA
Cook Inc.
Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 ...
Medical Implants·13,388 affected·Jan 4, 2019