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High RiskFDA
Abbott Point Of Care Inc.
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the qua...
Medical Devices·4,448,525 affected·Jan 14, 2020
High RiskFDA
Philips North America, Llc
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is inte...
Cardiac Devices·43 affected·Jan 14, 2020
High RiskFDA
Coopervision Inc.
Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
Medical Devices·216 affected·Jan 13, 2020
High RiskFDA
Philips North America, Llc
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different config...
Medical Devices·44,442 affected·Jan 13, 2020
High RiskFDA
Teleflex Medical Inc
Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440
Medical Devices·1,764 affected·Jan 13, 2020
High RiskFDA
C.r. Bard Inc
The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through ...
Surgical Devices·1,300 affected·Jan 13, 2020
High RiskFDA
Coopervision Inc.
Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
Medical Devices·24 affected·Jan 13, 2020
High RiskFDA
Cargill, Inc Corporate Headquarters
Marigold, INC. Granulated Cane Sugar Net Weight: 2000#
Food·93 affected·Jan 12, 2020
High RiskFDA
Sugar Foods Corporation
Granulate Pure Cane Sugar sold under the brand names of: Ahold 16 oz canister, DISTRIBUTED BY FOODHOLD USA, LLC, LANDOVER, MD 20758 UP...
Food·1,513 affected·Jan 12, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599
Surgical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545
Surgical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
ROYALSILK LARGE, Gown. Item Code 9518
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
ROYALSILK XLARGE, Gown. Item Code 9548
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
GOWN SURG LG W/TOWEL ST BACK, Item Code 9515
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585
Surgical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Cardinal Health
AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
Medical Devices·7,659,634 affected·Jan 11, 2020
High RiskFDA
Letco Medical Llc
Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01; c) 1 kg NDC 62991-2159-06; d) 25 gm NDC 62991-2159-03; e) ...
Drugs·597 affected·Jan 10, 2020
High RiskFDA
Advanced Accelerator Applications Usa, Inc.
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Adva...
Injectable Drugs·4,295 affected·Jan 10, 2020
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -c...
Oral Drugs·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Tosoh Bioscience Inc
AIA-360 Automated Immunoassay Analyzer, Product Code 019945
Diagnostic Devices·12 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion Assembly Pump Guts, 4 Inch, Catalog Number 801805 - Product Usage: is indicated for use for up to 6 hours in th...
Medical Devices·11 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
Medical Devices·0 affected·Jan 10, 2020
High RiskFDA
Biomet 3i, Llc
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
Medical Devices·0 affected·Jan 10, 2020