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High RiskFDA
New Seasons Market
Buttermilk Herb Side Salad, prepacked in a clear plastic container, sold by the unit for $2.99, UPC 252326-602998.
Dairy·333 affected·Dec 20, 2017
CriticalFDA
Auromedics Pharma Llc
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, ...
Injectable Drugs·9,050 affected·Dec 20, 2017
High RiskFDA
Odan Laboratories Ltd
Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Derm...
Topical Drugs·21 affected·Dec 20, 2017
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 4923...
Drugs·3,734 affected·Dec 20, 2017
High RiskFDA
Odan Laboratories Ltd
Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cre...
Topical Drugs·179 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Ad-tech Medical Instrument Corporation
Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long a...
Medical Devices·30 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal f...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH N...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAI...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Nidek Inc.
AUTO REF/KERATOMETER ARK-1s
Medical Devices·63 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Tr...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Merit Medical Systems, Inc.
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialy...
Medical Implants·0 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STER...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Integra Lifesciences Corp.
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product ...
Medical Devices·1,619 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Boston Scientific Corporation
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Surgical Devices·5,026 affected·Dec 20, 2017
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd fo...
Medical Implants·1,486 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteri...
Medical Devices·3,454 affected·Dec 20, 2017
CriticalCPSC
Matrix Fireworks Of Wahpeton, N.d. From May 2017 Through August 2017 For About $15.
Matrix Fireworks Recalls Fireworks Due to Violation of Federal Standard; Explosion and Burn Hazards
Consumer Products·56,200 affected·Dec 19, 2017
RecallCPSC
Del Mar Fans & Lighting, Pacific Ceiling Fans, Wilson Lighting And Other Lighting Stores Nationwide And Online From January 2016 Through September 2017 For Between $500 And $550.
Monte Carlo Recalls Ceiling Fans Due to Injury Hazard
Heating & Cooling·3,400 affected·Dec 19, 2017
RecallCPSC
Online At Squattypotty.com And Amazon.com From September 2017 Through November 2017 For About $50
Squatty Potty Recalls Children's Toilet Step Stools Due to Injury and Fall Hazards
Children's Products·2,400 affected·Dec 19, 2017
CriticalCPSC
Amazon.com From May 2016 Through May 2017 For Between $50 And $150.
Superior Importers Recalls Mattresses Due to Violation of Federal Mattress Flammability Standard; Sold Exclusively at Amazon.com
Consumer Products·6,200 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Sakkar Para, 1 lb. clear plastic clamshell containers.
Food·30 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Jalebi, .5-1 lb. Clear Plastic clamshell containers
Food·30 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
7oz Fruit and cheese Snacks - no brand. 1 unit per case
Dairy·160 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Laddu, 1 lb. clear plastic clamshell containers.
Food·15 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Gur Para 1 lb. clear plastic clamshell containers.
Food·30 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
9oz Mix (red/green) Slice Apples Container - Fresh-Pak brand. 1 unit per case
Food·121 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Mixed Sweets- variety 1 lb. clear plastic clamshell containers.
Food·0 affected·Dec 19, 2017
CriticalFDA
Kotecha Brothers, Llc.
Haldiram's Fresh Paneer Traditional Indian Soft Cottage Cheese, Net Weight 800g (28.2 oz)
Dairy·45 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
3lb Bag Dice Red Apples - no brand. 4 units per case
Food·440 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Namak Para 1 lb. clear plastic clamshell containers.
Food·25 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
5/2.5oz Slice Apples w/ grapes bags in clamshell - Aunt Mid s brand. 6 units per case
Food·108 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
9oz Slice Apples Container - Fresh-Pak brand. 1 unit per case
Food·114 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
5/2.2oz Slice Apple Bags in clamshell - Aunt Mid s Michigan Apples brand. 6 units per case
Food·2,658 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Badusha, 1 lb. clear plastic clamshell containers.
Food·10 affected·Dec 19, 2017
High RiskFDA
Unichem Pharmaceuticals Usa Inc
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, M...
Oral Drugs·96,876 affected·Dec 19, 2017
Medium RiskFDA
Perkinelmer Health Sciences, Inc.
PerkinElmer 226 Sample Collection Device
Medical Devices·164,952 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
Diagnostic Devices·72,730 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertili...
Medical Devices·1,900 affected·Dec 19, 2017
RecallFDA
Livanova Usa
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, ...
Medical Devices·16 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
Diagnostic Devices·71,640 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
Diagnostic Devices·1,980 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
Diagnostic Devices·3,122 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
Diagnostic Devices·18 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
Diagnostic Devices·358 affected·Dec 19, 2017