Skip to main content
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1)...
Medical Implants·951 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Us...
Medical Devices·57 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
Diagnostic Devices·5,040 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
Diagnostic Devices·20 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Eve...
Medical Implants·951 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: ...
Medical Implants·951 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB...
Medical Implants·951 affected·Dec 19, 2017
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine...
Surgical Devices·226 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Cathet...
Surgical Devices·473 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No...
Medical Implants·951 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
Diagnostic Devices·748 affected·Dec 19, 2017
High RiskFDA
Nipro Medical Corporation
Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. ...
Medical Devices·307,944 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vit...
Surgical Devices·21 affected·Dec 19, 2017
High RiskFDA
Ingles Markets
Frozen Buttermilk Biscuits 25 oz. bag (12 count) and 44 oz. bag (20 count)
Dairy·161 affected·Dec 18, 2017
CriticalFDA
Gel Spice Co, Inc.
Spice Supreme Beef Flavored Bouillon Cubes 1.7 oz (48 g) and NET WT. 3-1/2 OZ (98 g) 25 Count
Meat & Poultry·403 affected·Dec 18, 2017
RecallFDA
Barlean's Fishery Inc.
REEF NET brand Wild Pacific Smoked Salmon. Product is Ready-To-Eat, hot smoked, vacuum packaged in 1 lb.; 1.5 lbs.; and 2 lbs. package, ...
Seafood·1,584 affected·Dec 18, 2017
High RiskFDA
Ingles Markets
Frozen Southern Style Biscuits; 25 oz. bags (12 count)
Frozen Food·200 affected·Dec 18, 2017
CriticalFDA
Gel Spice Co, Inc.
Spice Supreme Beef Flavored Bouillon Cubes 1.7 oz (48 g) and NET WT. 3-1/2 OZ (98 g) 25 Count
Meat & Poultry·403 affected·Dec 18, 2017
CriticalFDA
Meijer Distribution, Inc
Meijer Michigan Harvest Salad 10 Oz retail unit in plastic container UPC: 7-08820-68400-3 4 retail containers per wholesale case
Produce·1,824 affected·Dec 18, 2017
CriticalFDA
Meijer Distribution, Inc
Meijer Sharable Waldorf Salad 16 Oz retail unit in plastic container UPC: 7-13733-53864-0 4 retail containers per wholesale case
Produce·1,244 affected·Dec 18, 2017
CriticalFDA
Meijer Distribution, Inc
Meijer Fresh Cranberry Apple Stuffing Starter 18.9 Oz retail unit in plastic container UPC: 7-19283-37977-1 4 retail containers per w...
Produce·768 affected·Dec 18, 2017
RecallFDA
Osmotica Pharmaceutical Corp
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ...
Oral Drugs·10,064 affected·Dec 18, 2017
RecallFDA
Osmotica Pharmaceutical Corp
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ ...
Oral Drugs·9,919 affected·Dec 18, 2017
High RiskFDA
Johnson & Johnson Consumer, Inc.
COACH¿ Self-Adhering Sports Wrap (size: 2in)
Medical Devices·0 affected·Dec 18, 2017
High RiskFDA
Phadia Us Inc
ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measu...
Diagnostic Devices·950 affected·Dec 18, 2017
High RiskFDA
Johnson & Johnson Consumer, Inc.
Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)
Medical Devices·0 affected·Dec 18, 2017
High RiskFDA
Johnson & Johnson Vision Care, Inc.
ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
Medical Devices·150 affected·Dec 18, 2017
High RiskFDA
Johnson & Johnson Consumer, Inc.
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)
Medical Devices·0 affected·Dec 18, 2017
High RiskFDA
Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular ...
Medical Devices·2,677 affected·Dec 18, 2017
High RiskFDA
Johnson & Johnson Consumer, Inc.
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)
Medical Devices·0 affected·Dec 18, 2017
CriticalFDA
Jack Brown Produce, Inc.
Gala, whole fresh apples; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5t...
Food·5,278 affected·Dec 17, 2017
CriticalFDA
Jack Brown Produce, Inc.
Golden Delicious whole fresh apples; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Tray...
Food·5,278 affected·Dec 17, 2017
CriticalFDA
Jack Brown Produce, Inc.
Fuji, whole fresh apples; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Trays-113ct (5t...
Food·5,278 affected·Dec 17, 2017
CriticalFDA
Jack Brown Produce, Inc.
Golden Del., Gala, Fuji, Honey Crisp; Metric Tray sizes, 50ct, 55ct, 60ct, 78ct, 113ct, 2# Poly bags, 3# Poly bags and 5# Mesh bags; Tra...
Food·5,278 affected·Dec 17, 2017
RecallUSDA
Unknown
Piller's Fine Foods Recalls Ready-To-Eat Salami and Speck Products due to Possible Salmonella Adulteration
Poultry·0 affected·Dec 16, 2017
RecallUSDA
Unknown
Piller's Fine Foods Retira Productos De Salami Y Prosciutto Debido A Posible Adulteracin Con Salmonella
Meat & Poultry·0 affected·Dec 16, 2017
High RiskFDA
B. Braun Medical Inc
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-230...
Drugs·2,576 affected·Dec 15, 2017
RecallFDA
Akorn Inc
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc....
Oral Drugs·4,885 affected·Dec 15, 2017
High RiskFDA
Amneal Pharmaceuticals
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-...
Injectable Drugs·12,584 affected·Dec 15, 2017
High RiskFDA
Ge Healthcare, Llc
Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory t...
Medical Devices·355 affected·Dec 15, 2017
High RiskFDA
Ge Healthcare, Llc
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novi...
Medical Devices·1,742 affected·Dec 15, 2017
High RiskFDA
Trumpf Medical Systems, Inc.
Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpos...
Surgical Devices·212 affected·Dec 15, 2017
High RiskFDA
Depuy Spine, Inc.
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) ...
Medical Devices·1,972 affected·Dec 15, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear im...
Medical Devices·1,387 affected·Dec 15, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single p...
Medical Devices·1,387 affected·Dec 15, 2017
RecallCPSC
Crate And Barrel Stores Nationwide And Online At Www.crateandbarrel.com From September 2011 Through November 2017 For About $600 For The 51-inch Bench And About $800 For The 71-inch Bench.
Crate and Barrel Recalls Benches Due to Fall Hazard (Recall Alert)
Consumer Products·6,800 affected·Dec 14, 2017
Medium RiskCPSC
Costco Stores Nationwide And Online At Costco.com From January 2016 Through August 2017 For About $130; Refurbished Fans Were Sold Online During The Same Period On Ebay, Amazon, And Groupon.
Hunter Fan Recalls Ceiling Fans Due to Impact Injury Hazard; New Instructions Provided
Heating & Cooling·168,000 affected·Dec 14, 2017
RecallCPSC
Pier 1 Imports Stores Nationwide And Online At Www.pier1.com From June 2017 Through November 2017 For About $25 For The Small Glass Pumpkin And About $30 For The Medium Glass Pumpkin.
Pier 1 Imports Recalls Decorative Glass Pumpkins Due to Laceration Hazard
Consumer Products·16,600 affected·Dec 14, 2017