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
CriticalFDA
Pfizer Inc.
Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02
Injectable Drugs·102,500 affected·Aug 30, 2017
High RiskFDA
Pfizer Inc.
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL ...
Injectable Drugs·115,370 affected·Aug 22, 2017
High RiskFDA
Pfizer Inc.
Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc...
Injectable Drugs·98,050 affected·Aug 22, 2017
High RiskFDA
Vital Rx, Inc. Dba Atlantic Pharmacy And Compounding
All Sterile Products within expiry
Drugs·61 affected·Aug 17, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Drugs·5 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Drugs·7 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Drugs·2,334 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.
Drugs·45 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Drugs·644 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.
Drugs·200 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Drugs·10 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Drugs·30 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.
Topical Drugs·6 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA.
Drugs·82 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Drugs·5 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) B...
Ophthalmic Drugs·6 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Drugs·20 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Drugs·5 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Drugs·3 affected·Aug 15, 2017
High RiskFDA
Bella Pharmaceuticals, Inc.
Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Drugs·5 affected·Aug 15, 2017
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospi...
Injectable Drugs·0 affected·Aug 10, 2017
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/of...
Injectable Drugs·0 affected·Aug 10, 2017
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; ...
Injectable Drugs·0 affected·Aug 10, 2017
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospita...
Injectable Drugs·0 affected·Aug 10, 2017
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/offic...
Injectable Drugs·0 affected·Aug 10, 2017
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office...
Injectable Drugs·0 affected·Aug 10, 2017
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx...
Injectable Drugs·0 affected·Aug 10, 2017
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx ...
Injectable Drugs·0 affected·Aug 10, 2017
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospita...
Injectable Drugs·0 affected·Aug 10, 2017
High RiskFDA
Ssm Health Care St. Louis Dba Ssm St. Clare Health Center
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; ...
Injectable Drugs·0 affected·Aug 10, 2017
High RiskFDA
Microvention, Inc.
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Medical Devices·34 affected·Aug 7, 2017
High RiskFDA
Ultradent Products, Inc.
Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product is used to assure ...
Medical Devices·62 affected·Aug 4, 2017
High RiskFDA
Ultradent Products, Inc.
Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure ...
Medical Devices·95 affected·Aug 4, 2017
High RiskFDA
Ultradent Products, Inc.
Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure t...
Medical Devices·61 affected·Aug 4, 2017
High RiskFDA
Ultradent Products, Inc.
Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product Usage: The product is used to assure t...
Medical Devices·26 affected·Aug 4, 2017
High RiskFDA
Ultradent Products, Inc.
Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure ...
Medical Devices·210 affected·Aug 4, 2017
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 005850012...
Medical Devices·3,350 affected·Aug 1, 2017
High RiskFDA
Icu Medical, Inc.
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile The blood tu...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intende...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blo...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE C...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, St...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Ste...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, Sterile The blood tubing accessory...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Con...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Vol...
Medical Devices·160,016 affected·Jul 31, 2017