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
Medaus, Inc.
B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12 1MG/ML, In a) 2ML Vials, b) 5...
Drugs·62 affected·May 13, 2016
High RiskFDA
Medaus, Inc.
TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and e) 5ML Vials, MEDAUS PHARMACY
Drugs·8,000 affected·May 13, 2016
High RiskFDA
Medaus, Inc.
METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
Drugs·600 affected·May 13, 2016
High RiskFDA
Medaus, Inc.
CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
Drugs·8,500 affected·May 13, 2016
High RiskFDA
Medaus, Inc.
TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PH...
Drugs·150 affected·May 13, 2016
High RiskFDA
Medaus, Inc.
PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Drugs·1,500 affected·May 13, 2016
High RiskFDA
Medaus, Inc.
ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), 3ML Vials, MEDAUS PHARMACY
Drugs·10 affected·May 13, 2016
High RiskFDA
Medaus, Inc.
THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY
Drugs·213 affected·May 13, 2016
High RiskFDA
Medaus, Inc.
B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 2ML Vials, MEDAUS PHARMACY
Drugs·1,000 affected·May 13, 2016
High RiskFDA
Medaus, Inc.
MANGANESE CHL 0.1MG/ML PF, 10ML Vials, MEDAUS PHARMACY
Drugs·1,000 affected·May 13, 2016
High RiskFDA
Synthes (usa) Products Llc
Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are n...
Medical Devices·2,098 affected·May 11, 2016
High RiskFDA
Medical Vision Ab
Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction durin...
Diagnostic Devices·3,295 affected·May 10, 2016
High RiskFDA
Datascope Corporation
Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be ...
Cardiac Devices·17 affected·May 9, 2016
High RiskFDA
Intuitive Surgical, Inc.
SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical S...
Surgical Devices·46,191 affected·May 9, 2016
High RiskFDA
Intuitive Surgical, Inc.
SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Sur...
Surgical Devices·46 affected·May 9, 2016
RecallUSDA
Legacy Beef, Llc
Washington Firm Recalls Beef Jerky Products That May Be Undercooked
Beef·0 affected·May 7, 2016
High RiskFDA
Teleflex Medical
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A ...
Medical Devices·6,390 affected·May 5, 2016
High RiskFDA
Zimmer Manufacturing B.v.
VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
Medical Devices·50 affected·May 4, 2016
High RiskFDA
Zimmer Manufacturing B.v.
ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
Medical Devices·50 affected·May 4, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap...
Medical Devices·3,893 affected·May 4, 2016
High RiskFDA
Zimmer Manufacturing B.v.
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 ...
Medical Devices·219 affected·May 4, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threade...
Medical Devices·3,955 affected·May 4, 2016
High RiskFDA
Lymol Medical
Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporat...
Drugs·25,007 affected·Apr 28, 2016
High RiskFDA
Teva North America
Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Bo...
Injectable Drugs·546 affected·Apr 27, 2016
High RiskFDA
Greatbatch Medical
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, ...
Medical Devices·1,110 affected·Apr 26, 2016
High RiskFDA
Fresenius Kabi Usa, Llc
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60...
Injectable Drugs·69,225 affected·Apr 25, 2016
High RiskFDA
Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a singl...
Medical Implants·630 affected·Apr 21, 2016
High RiskFDA
Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single...
Medical Implants·315 affected·Apr 21, 2016
High RiskFDA
Baxter Healthcare Corp.
GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single...
Medical Implants·707 affected·Apr 21, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, N...
Drugs·70 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 4...
Drugs·72 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, ...
Drugs·24 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45...
Drugs·10 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-...
Drugs·40 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70
Drugs·50 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, ...
Drugs·400 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pha...
Drugs·90 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, ...
Drugs·1,200 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Nob...
Drugs·40 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Nob...
Drugs·25 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67
Drugs·40 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, N...
Drugs·560 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060...
Drugs·10 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-097...
Drugs·1,200 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060,...
Drugs·800 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Nob...
Injectable Drugs·675 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 4...
Drugs·216 affected·Apr 20, 2016
High RiskFDA
Pharmakon Pharmaceuticals, Inc.
Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060...
Drugs·129 affected·Apr 20, 2016