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High RiskFDA
Nextremity Solutions
Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a pl...
Medical Devices·40 affected·Dec 16, 2019
High RiskFDA
Synthes, Inc.
2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system t...
Medical Devices·25 affected·Dec 16, 2019
High RiskFDA
Bakkavor Foods Usa Inc.
HOME CHEF HEAT & EAT Baked Macaroni & Cheese NET WT. 12 oz (340G) keep refrigerated, Distributed by: The Kroger Co., Cincinnati, Ohio 452...
Dairy·3,642 affected·Dec 14, 2019
High RiskFDA
Wayfare Health Foods Llc
Plant Based WayFare Butterscotch Pudding Organic Dairy Free, Item #1223. Net wt. 4 oz. There are 4/4 oz. cups per pack with cardboard ove...
Dairy·4,699 affected·Dec 13, 2019
High RiskFDA
Wayfare Health Foods Llc
Plant Based WayFare Vanilla Pudding Organic Dairy Free, Item #1221. Net wt. 4 oz. There are 4/4 oz. cups per pack with cardboard overwra...
Dairy·4,699 affected·Dec 13, 2019
High RiskFDA
Unfi General Corporate
Essential Everyday, Unbleached Flour, Enriched All-Purpose Pre-Sifted, packaged in a 5lb paper bag
Food·1,440 affected·Dec 13, 2019
High RiskFDA
Granules India Limited
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Oral Drugs·23,090,000 affected·Dec 13, 2019
High RiskFDA
Coopersurgical, Inc.
ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product...
Surgical Devices·460 affected·Dec 13, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculat...
Medical Devices·3,472 affected·Dec 13, 2019
High RiskFDA
Zimmer Biomet, Inc.
Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)6...
Medical Implants·3 affected·Dec 12, 2019
High RiskFDA
Baxter Healthcare Corporation
Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fl...
Medical Devices·271,014,984 affected·Dec 12, 2019
High RiskFDA
Remedyrepack Inc.
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Oral Drugs·4,486 affected·Dec 11, 2019
High RiskFDA
Spectrum Laboratory Products
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 ...
Drugs·6 affected·Dec 11, 2019
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Diabetes Devices·82,332 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESS...
Surgical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- ENT SNUF3 SNUFFER KIT Y
Medical Devices·146 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY
Medical Devices·108 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION T...
Surgical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY
Medical Devices·60 affected·Dec 11, 2019
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
Diabetes Devices·92,836 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY C...
Medical Devices·448 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
Medical Devices·100 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATH. INSERTION
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- OR2020 BASIN SET
Medical Devices·188 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
Medical Devices·1,100 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Port Draw Kit KNV30 PORT DRAW KIT
Medical Devices·75 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- LC145 STERILE NICU LINE CHANGE KIT
Medical Devices·160 affected·Dec 11, 2019
High RiskFDA
Abaxis Inc
Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)
Medical Devices·15 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF109...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KIT
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY
Surgical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Brasseler Usa I Lp
Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used ...
Medical Devices·56 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPO...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C C...
Medical Implants·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A ...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM
Medical Devices·1,820 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion IVS3505 ULTRASOUND GUIDED PIV KIT
Medical Devices·350 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRA...
Surgical Devices·1,986 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT10770 DEBRIDEMENT/SUTURE SET SUT10795...
Medical Implants·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PIC...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIV...
Cardiac Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION...
Surgical Devices·0 affected·Dec 11, 2019
High RiskFDA
Asclemed Usa Inc. Dba Enovachem Pharmaceuticals
Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
Drugs·8 affected·Dec 9, 2019
High RiskFDA
Asclemed Usa Inc. Dba Enovachem Pharmaceuticals
Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
Drugs·42 affected·Dec 9, 2019