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
Conmed Corporation
ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" b...
Medical Devices·2,931 affected·Mar 21, 2019
High RiskFDA
Conmed Corporation
ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED ...
Medical Devices·5,034 affected·Mar 21, 2019
High RiskFDA
Nobel Biocare Usa Llc
Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for pr...
Medical Implants·0 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prep...
Medical Implants·473 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prep...
Medical Implants·260 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteoto...
Medical Implants·0 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy ...
Medical Implants·264 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing os...
Medical Implants·0 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw...
Medical Implants·233 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific in...
Medical Devices·7 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepar...
Medical Implants·0 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepa...
Medical Implants·8 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for prepari...
Medical Implants·8 affected·Mar 14, 2019
High RiskFDA
Nobel Biocare Usa Llc
Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has...
Medical Implants·197 affected·Mar 14, 2019
High RiskFDA
Advanced Pharma Inc.
Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe...
Injectable Drugs·2,325 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella ...
Injectable Drugs·360 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, ND...
Injectable Drugs·22,900 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265...
Injectable Drugs·1,540 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe...
Injectable Drugs·1,440 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syring...
Injectable Drugs·1,575 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 42852-827-61 Avella of Houston 9265 Kirb...
Injectable Drugs·550 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Hou...
Injectable Drugs·180 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby ...
Injectable Drugs·2,580 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL) NDC: 42852-802-61 Avella...
Injectable Drugs·1,850 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Ave...
Injectable Drugs·140 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 926...
Injectable Drugs·1,980 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use...
Injectable Drugs·800 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC:...
Injectable Drugs·1,125 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syr...
Injectable Drugs·16,075 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 428...
Injectable Drugs·500 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 4...
Injectable Drugs·2,400 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use s...
Injectable Drugs·975 affected·Mar 13, 2019
High RiskFDA
Advanced Pharma Inc.
Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 A...
Injectable Drugs·5,700 affected·Mar 13, 2019
High RiskFDA
Covidien Llc
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diame...
Medical Devices·7,248 affected·Mar 13, 2019
High RiskFDA
Covidien Llc
Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has application...
Medical Devices·240 affected·Mar 13, 2019
High RiskFDA
Covidien Llc
Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT0068...
Medical Devices·148 affected·Mar 13, 2019
High RiskFDA
Msm Nutraceuticals, Llc
Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufact...
Ophthalmic Drugs·200 affected·Mar 12, 2019
High RiskFDA
Msm Nutraceuticals, Llc
Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactu...
Ophthalmic Drugs·200 affected·Mar 12, 2019
High RiskFDA
Msm Nutraceuticals, Llc
Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology D...
Drugs·500 affected·Mar 12, 2019
High RiskFDA
Msm Nutraceuticals, Llc
15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027...
Ophthalmic Drugs·5,000 affected·Mar 12, 2019
High RiskFDA
Iso-tex Diagnostics, Inc
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diag...
Injectable Drugs·54 affected·Mar 11, 2019
High RiskFDA
Stryker Corporation
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Medical Devices·32,537 affected·Mar 7, 2019
High RiskFDA
Stryker Corporation
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator...
Medical Devices·5,089 affected·Mar 7, 2019
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam -...
Injectable Drugs·5,755 affected·Mar 6, 2019
High RiskFDA
Procept Biorobotics Corporation
AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the...
Medical Devices·214 affected·Mar 6, 2019
RecallFDA
Petra Hygienic Systems Int Ltd
ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons p...
Drugs·58 affected·Mar 4, 2019
High RiskFDA
Thoratec Corp.
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assi...
Cardiac Devices·650 affected·Mar 1, 2019
High RiskFDA
Medical Action Industries Inc
Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Num...
Medical Devices·228,300 affected·Mar 1, 2019