Skip to main content
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
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
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
High RiskFDA
New Punjab Sweets Inc.
Mixed Sweets- variety 1 lb. clear plastic clamshell containers.
Food·0 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Namak Para 1 lb. clear plastic clamshell containers.
Food·25 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
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
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
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
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
High RiskFDA
Ingles Markets
Frozen Southern Style Biscuits; 25 oz. bags (12 count)
Frozen Food·200 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
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
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
High RiskFDA
Shiseido America Inc.
Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged...
Drugs·0 affected·Dec 14, 2017
High RiskFDA
Shiseido America Inc.
Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), pac...
Drugs·0 affected·Dec 14, 2017
High RiskFDA
Boehringer Ingelheim Pharmaceuticals, Inc.
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Ger...
Oral Drugs·45,008 affected·Dec 14, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTI...
Oral Drugs·4,969 affected·Dec 14, 2017
High RiskFDA
Shiseido America Inc.
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare ...
Drugs·248,661 affected·Dec 14, 2017
High RiskFDA
Shiseido America Inc.
Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc ...
Drugs·0 affected·Dec 14, 2017
High RiskFDA
Shiseido America Inc.
Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4...
Drugs·0 affected·Dec 14, 2017
High RiskFDA
Kalila Medical
Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile...
Medical Devices·99 affected·Dec 14, 2017
High RiskFDA
Dynavox Systems Llc
Dynavox T10 Speech Generating Device ( including Batteries)
Medical Devices·4,615 affected·Dec 14, 2017