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
Resource Optimization & Innovation Llc
Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
Surgical Devices·80 affected·Aug 25, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
Cardiac Devices·57 affected·Aug 25, 2015
High RiskFDA
C.r. Bard, Inc.
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film...
Surgical Devices·8,970 affected·Aug 24, 2015
High RiskFDA
Teleflex Medical
Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
Medical Devices·233,641 affected·Aug 24, 2015
CriticalFDA
Cantrell Drug Company
fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC ...
Injectable Drugs·1,652 affected·Aug 21, 2015
High RiskFDA
Nephron Pharmaceuticals Corp.
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC ...
Drugs·85,248 affected·Aug 21, 2015
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakene...
Medical Devices·9,805 affected·Aug 20, 2015
High RiskFDA
Bausch & Lomb, Inc.
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-43...
Ophthalmic Drugs·13,995 affected·Aug 17, 2015
CriticalFDA
Hartley Medical Center Pharmacy, Incorporated
Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 100 mL vial, Rx Only, Hartley Medical, (888) 671-2888
Drugs·10 affected·Aug 17, 2015
CriticalFDA
Hartley Medical Center Pharmacy, Incorporated
Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, ...
Drugs·14 affected·Aug 17, 2015
RecallFDA
Abbott Electrophysiology
FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only ...
Cardiac Devices·86 affected·Aug 12, 2015
High RiskFDA
Revmedx Inc
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual co...
Medical Devices·5,004 affected·Aug 12, 2015
High RiskFDA
Zimmer, Inc.
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to f...
Medical Implants·18 affected·Aug 11, 2015
High RiskFDA
International Biophysics Corp.
IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use...
Surgical Devices·771 affected·Aug 7, 2015
High RiskFDA
Covidien Llc
Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushin...
Medical Devices·207,876 affected·Aug 6, 2015
High RiskFDA
Covidien Llc
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product ...
Surgical Devices·569 affected·Aug 6, 2015
High RiskFDA
Covidien Llc
Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Pr...
Surgical Devices·8 affected·Aug 6, 2015
High RiskFDA
Tornier, Inc
Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
Surgical Devices·5 affected·Aug 6, 2015
High RiskFDA
Covidien Llc
Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 ...
Surgical Devices·165 affected·Aug 6, 2015
High RiskFDA
Covidien Llc
Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: ...
Surgical Devices·116 affected·Aug 6, 2015
High RiskFDA
Trilliant Surgical Ltd.
7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-ST...
Medical Devices·28 affected·Aug 6, 2015
High RiskFDA
Covidien Llc
MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Pro...
Surgical Devices·325 affected·Aug 6, 2015
High RiskFDA
Covidien Llc
Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm Item Code: 8888213420 ...
Surgical Devices·4 affected·Aug 6, 2015
High RiskFDA
Covidien Llc
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP P...
Surgical Devices·550 affected·Aug 6, 2015
High RiskFDA
Boston Scientific Corporation
AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. ...
Medical Devices·9 affected·Jul 31, 2015
High RiskFDA
Edward Lifesciences, Llc
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when atta...
Surgical Devices·13,077 affected·Jul 31, 2015
High RiskFDA
Boston Scientific Corporation
AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. ...
Medical Devices·9 affected·Jul 31, 2015
High RiskFDA
Boston Scientific Corporation
AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. ...
Medical Devices·9 affected·Jul 31, 2015
High RiskFDA
Trilliant Surgical Ltd.
2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Pl...
Medical Devices·108 affected·Jul 31, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
PROGESTERONE, Pellet, 50mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)76...
Drugs·5 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
METHIONINE/CHOLINE/INOSITOL, injectable Solution, 25/50/50 MG/ML, 10 mL syringes, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharm...
Injectable Drugs·2 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
PAPAVERINE/PHENTOLAMINE, Injectable Solution, 30MG/1MG/ML, 10 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 15...
Injectable Drugs·8 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
HYDROXYPROGESTERONE CAPROATE OIL, injectable Solution, 250 mg/mL, syringe sizes: 4 mL; 5 mL; 6 mL; 10 mL; 16 mL; 18 mL; 20 mL; and 22 mL,...
Injectable Drugs·3 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
TESTOSTERONE/ANASTROZOLE, Pellet, 200/13 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake W...
Drugs·60 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
ESTRADIOL, Pellet, 3 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-...
Drugs·68 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
CHORIONIC GONADOTROPIN, Injectable Solution, 1000 UNITS/0.1 mL, 1 mL vial, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 15...
Injectable Drugs·95 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
TRIMIX, injectable Solution, 30MG/1MG/20MCG, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St...
Injectable Drugs·6 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
ESTRADIOL, Pellet, 75 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764...
Drugs·6 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
CHORIONIC GONADOTROPIN, Injectable Solution, 5000 UNITS/0.1 mL, vial sizes: 5 mL; 6 mL; 8 mL; 10 mL, Rx only, JD & SN Inc, DBA Moses Lak...
Injectable Drugs·9 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
METHYLCOBALAMIN, Injectable Solution, 15 MG/ML, syringe sizes: 5 mL; 6 mL; 10 mL; 15 mL; 20 mL; 30 mL, Rx only, JD & SN Inc, DBA Moses La...
Injectable Drugs·1 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
CYANOCOBALAMIN MDV (COMPOUNDED), Injectable Solution, 1 MG/ML per syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 15...
Injectable Drugs·30 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
MEDROXYPROGESTERONE ACETATE, injectable Solution,150MG/ML, 10mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555...
Injectable Drugs·11 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
ESTRADIOL, Injectable Solution, 20 mg/mL, 5 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. ...
Injectable Drugs·2 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
ETHYL ALCOHOL (STERILE FOR INJECTION) 100%, Injectable Solution, 200 PROOF, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professio...
Injectable Drugs·1 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
ESTRADIOL, Pellet, 12 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-...
Drugs·1 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
SERMORELIN/GHRP-6/GHRP-2, Injectable Solution, 9/5.4/5.4MG/9ML, 9mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, ...
Injectable Drugs·165 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
TESTOSTERONE, Pellet, 76 mg, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)...
Drugs·18 affected·Jul 24, 2015
High RiskFDA
Jd & Sn Inc., Dba Moses Lake Professional Pharmacy
HYDROXYCOBALAMINE/METHYLCOBALAMINE PF UNIT DOSE, Injectable Solution, 1.5/1.5 mg/0.25 mL per syringe, Rx only, JD & SN Inc, DBA Moses Lak...
Injectable Drugs·5 affected·Jul 24, 2015