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High RiskFDA
Defibtech, Llc
DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463...
Cardiac Devices·860 affected·Apr 27, 2020
High RiskFDA
Defibtech, Llc
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A101...
Cardiac Devices·860 affected·Apr 27, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination ...
Cardiac Devices·260 affected·Apr 27, 2020
High RiskFDA
Argon Medical Devices, Inc
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introduc...
Surgical Devices·15,795 affected·Apr 26, 2020
High RiskFDA
Middle East Bakery, Inc.
Joseph's Gluten Free Original Wrap, 4 wraps, Net. Wt. 5.6 oz., UPC Code: 074117-003612
Food·7,133 affected·Apr 25, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
Medical Devices·240 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
Medical Devices·325 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
Medical Devices·768 affected·Apr 24, 2020
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack ...
Cardiac Devices·352 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
Medical Devices·48 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
Medical Devices·72 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
Medical Devices·984 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The...
Medical Devices·36 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. T...
Medical Devices·41 affected·Apr 24, 2020
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The...
Medical Devices·6 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
Medical Devices·24 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
Medical Devices·220 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
Medical Devices·420 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
Medical Devices·860 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
Medical Devices·600 affected·Apr 24, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: ...
Medical Devices·110 affected·Apr 23, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray Syste...
Medical Devices·5 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is...
Medical Devices·120 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: i...
Medical Devices·6,254 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - Product Usage: is us...
Medical Devices·50 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Produc...
Surgical Devices·570 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/10859821006220 - Product Usage: is use...
Medical Devices·30 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is use...
Medical Devices·2,697 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - Product Usage: is us...
Medical Devices·6 affected·Apr 23, 2020
High RiskFDA
Olympus Corporation Of The Americas
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Medical Devices·18 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is use...
Medical Devices·7,395 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: ...
Medical Devices·1,864 affected·Apr 23, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number ...
Medical Implants·4,172 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 7133184...
Medical Implants·1,267 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 7133...
Medical Implants·1,766 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 4...
Medical Implants·1,450 affected·Apr 22, 2020
High RiskFDA
Smith & Nephew, Inc.
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number ...
Medical Implants·58 affected·Apr 22, 2020
High RiskFDA
Biosense Webster
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV Hig...
Cardiac Devices·0 affected·Apr 22, 2020
High RiskFDA
Sandoz, Inc
Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Hea...
Drugs·17,500 affected·Apr 21, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical perso...
Cardiac Devices·130 affected·Apr 21, 2020
High RiskFDA
La Sonorense, Inc.
12", 10" Pressed Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. ...
Food·576 affected·Apr 20, 2020
High RiskFDA
Ocean Spray Cranberries Inc.
5.5 oz cans of Ocean Spray Pink Lite Cranberry Juice Drink
Beverages·206,106 affected·Apr 20, 2020
High RiskFDA
La Sonorense, Inc.
14", 10" Hand Stretched Whole Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and plac...
Food·576 affected·Apr 20, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured...
Oral Drugs·11,808 affected·Apr 20, 2020
High RiskFDA
Fresenius Kabi Usa, Llc
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Si...
Injectable Drugs·3,497,575 affected·Apr 20, 2020
High RiskFDA
Trividia Health, Inc.
TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fres...
Diabetes Devices·1 affected·Apr 20, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to pro...
Medical Devices·16 affected·Apr 20, 2020
High RiskFDA
Cardinal Health Inc.
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all ...
Medical Devices·0 affected·Apr 20, 2020