Skip to main content
High RiskFDA
Kanan Enterprises, Inc.
Market District Roasted Salted Cashews Whole Fancy Net WT 26 oz (1LB 10 OZ) 737g. Ingredients: Cashews, Canola and/or Peanut Oil, Salt. ...
Food·228 affected·Apr 13, 2018
High RiskFDA
Lyne Laboratories, Inc.
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA...
Topical Drugs·23,453 affected·Apr 13, 2018
High RiskFDA
Lyne Laboratories, Inc.
Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufac...
Topical Drugs·17,939 affected·Apr 13, 2018
High RiskFDA
Lyne Laboratories, Inc.
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA...
Topical Drugs·12,572 affected·Apr 13, 2018
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Medical Devices·276 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e)...
Medical Devices·706 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Medical Devices·323 affected·Apr 13, 2018
High RiskFDA
St Jude Medical, Cardiac Rhythm Management Division
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name o...
Cardiac Devices·2,906 affected·Apr 13, 2018
High RiskFDA
Cardiovascular Systems Inc
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Us...
Medical Implants·18 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Medical Devices·532 affected·Apr 13, 2018
High RiskFDA
Coltene Whaledent Inc
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tu...
Medical Devices·11 affected·Apr 13, 2018
High RiskFDA
Trimed Inc.
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f)...
Medical Devices·1,194 affected·Apr 13, 2018
High RiskFDA
Riba Foods Inc
Four J Charred Tomato & Basil Sauce 24 oz packaged in a glass jar, 6 units per case
Produce·1,087 affected·Apr 11, 2018
High RiskFDA
Premier Pharmacy Labs Inc
NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34...
Drugs·600 affected·Apr 11, 2018
High RiskFDA
Premier Pharmacy Labs Inc
Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-...
Injectable Drugs·4,555 affected·Apr 11, 2018
High RiskFDA
Premier Pharmacy Labs Inc
Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-...
Injectable Drugs·4,192 affected·Apr 11, 2018
High RiskFDA
Premier Pharmacy Labs Inc
Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10
Drugs·3,570 affected·Apr 11, 2018
High RiskFDA
Stryker Neurovascular
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Surgical Devices·968 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
8Fr. Catheter Clamp with Fastener; Product Code: CC-00008
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Becton Dickinson & Company
The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, t...
Diagnostic Devices·0 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Maximal Barrier Drape; Product Code: ASK-04000-HMC
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 ...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Ca...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Maximal Barrier Drape; Product Codes: ASK-00001-1A
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safe...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703...
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Epidural Needle; Product Codes: AN-05501 and AN-05505
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Radial Arterial Access Kit; Product Code: ASK-04001-BID2
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Arterial Catheterization Kit; Product Code:NA-04550-1A
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Extension Line Slide Clamps; Product codes: SA-09847
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal B...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal...
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
PICC Catheter Trimmer ; Product Code:PC-00001-T
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-H...
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO
Medical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
TheraCath(R) Epidural Catheter; Product Code: EC-05000
Surgical Devices·416,055 affected·Apr 11, 2018
High RiskFDA
Arrow International Inc
7Fr. Catheter Clamp with Fastener; Product Code: CC-00007
Surgical Devices·416,055 affected·Apr 11, 2018