Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Mayne Pharma Usa
Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmac...
Ophthalmic Drugs·52,034 affected·Jan 5, 2016
High RiskFDA
Salter Labs
T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use i...
Medical Devices·70 affected·Jan 5, 2016
CriticalFDA
Complete Pharmacy And Medical Solutions Llc
Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only, Complete Pharmacy & Medical Solutions...
Drugs·1,890 affected·Dec 29, 2015
High RiskFDA
Texasstar Pharmacy
Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023
Drugs·700 affected·Dec 29, 2015
High RiskFDA
Amerita Specialty Infusion Services
IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Ameri...
Drugs·1 affected·Dec 24, 2015
High RiskFDA
Amerita Specialty Infusion Services
Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Drugs·1 affected·Dec 24, 2015
High RiskFDA
Pro-dex Inc
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
Surgical Devices·1,995 affected·Dec 23, 2015
High RiskFDA
Pro-dex Inc
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdr...
Surgical Devices·1,995 affected·Dec 23, 2015
High RiskFDA
Acist Medical Systems
ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only...
Surgical Devices·48,614 affected·Dec 21, 2015
High RiskFDA
Innovasis, Inc
Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-s...
Medical Implants·17 affected·Dec 7, 2015
High RiskFDA
Steris Corporation
Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow un...
Medical Devices·809 affected·Dec 4, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD,...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Becton Dickinson & Company
BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, ...
Medical Devices·29,815,600 affected·Dec 3, 2015
High RiskFDA
Josnoe Medical, Inc.
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
Medical Devices·1,008 affected·Dec 1, 2015
High RiskFDA
Synthes (usa) Products Llc
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Surgical Devices·65 affected·Dec 1, 2015
High RiskFDA
Aesculap, Inc.
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicat...
Medical Devices·1,232 affected·Nov 30, 2015
High RiskFDA
Abeon Medical Corporation
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid...
Medical Implants·575 affected·Nov 25, 2015
High RiskFDA
Abeon Medical Corporation
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
Surgical Devices·1,035 affected·Nov 25, 2015
High RiskFDA
Abeon Medical Corporation
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retractio...
Medical Devices·2,570 affected·Nov 25, 2015
High RiskFDA
Kci Usa, Inc.
ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home c...
Medical Devices·12,728 affected·Nov 25, 2015
High RiskFDA
Steris Corporation
AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irri...
Surgical Devices·2,319 affected·Nov 20, 2015
High RiskFDA
Cook Inc.
VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles ...
Surgical Devices·35 affected·Nov 19, 2015
High RiskFDA
Nephron Pharmaceuticals Corp.
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains s...
Respiratory Devices·11,208 affected·Nov 16, 2015
High RiskFDA
Sterilmed, Inc.
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
Medical Devices·174,960 affected·Nov 13, 2015
High RiskFDA
Walgreens Infusion Services
0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·7 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Injectable Drugs·7 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·14 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·52 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·27 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Supplements·20 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Piperacillin/Tazobactam (Zosyn) Accuflo bag, a) 18 g/NS 275 mL b) 4.5 g/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San ...
Drugs·26 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·14 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·7 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·40 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Injectable Drugs·5 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·23 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·1 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·1 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c) Vancomycin 1G/NS 250 mL, d) 1.5G/NS 250 mL e) 750 mg/NS ...
Injectable Drugs·95 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Famotidine injection syringe a) 10 mg/1 mL b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Injectable Drugs·21 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·7 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232...
Injectable Drugs·9 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·46 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syrin...
Injectable Drugs·49 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·35 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Injectable Drugs·43 affected·Nov 10, 2015