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
Pharmcore Inc.
Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Drugs·1,115 affected·Aug 2, 2018
High RiskFDA
Pharmcore Inc.
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Drugs·5,718 affected·Aug 2, 2018
High RiskFDA
Pharmcore Inc.
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Drugs·599 affected·Aug 2, 2018
High RiskFDA
Pharmcore Inc.
Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Drugs·2,085 affected·Aug 2, 2018
High RiskFDA
Pharmcore Inc.
Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Drugs·3,070 affected·Aug 2, 2018
High RiskFDA
Pharmcore Inc.
Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Drugs·864 affected·Aug 2, 2018
High RiskFDA
Zimmer Biomet, Inc.
Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthrop...
Medical Devices·16 affected·Aug 2, 2018
High RiskFDA
Covidien Llc
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondar...
Medical Devices·2,730,821 affected·Aug 1, 2018
High RiskFDA
Covidien Llc
Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressi...
Medical Devices·2,730,821 affected·Aug 1, 2018
High RiskFDA
Covidien Llc
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and se...
Medical Devices·2,730,821 affected·Aug 1, 2018
High RiskFDA
Covidien Llc
Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dr...
Medical Devices·2,730,821 affected·Aug 1, 2018
CriticalFDA
Endologix
ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/R...
Medical Devices·56,503 affected·Jul 31, 2018
CriticalFDA
Endologix
ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-...
Medical Implants·45,304 affected·Jul 31, 2018
CriticalFDA
Endologix
ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20...
Medical Implants·13,178 affected·Jul 31, 2018
High RiskFDA
Zimmer Biomet Spine Inc.
Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for ...
Medical Devices·16,429 affected·Jul 30, 2018
High RiskFDA
Zimmer Biomet Spine Inc.
Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletal...
Medical Devices·16,429 affected·Jul 30, 2018
High RiskFDA
Zimmer Biomet Spine Inc.
Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skelet...
Medical Devices·16,429 affected·Jul 30, 2018
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
Medical Devices·3 affected·Jul 30, 2018
High RiskFDA
Ranier's Compounding Laboratory
Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranie...
Injectable Drugs·1 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue S...
Injectable Drugs·2 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
P/P/P 0.02/40/2mg/mL(Prostaglandin//Papaverine/Phentolamine) Injection, 0.02/40/2 mg/mL, 1 mL vial, Rx only, Ranier's Rx Laboratory, 1107...
Injectable Drugs·1 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Drugs·213 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
PRASH 12.2mcg/1.22m/19.29 (Prostaglandin/Phentolamine/Papaverine) Injection, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Aven...
Injectable Drugs·1 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
Acetylcysteine 10% Oph Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Drugs·1 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) Injection,300 mg/5 mg/10 mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry A...
Injectable Drugs·2 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
Vitamin D3 Injection, 50,000 IU/mL, 4 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Injectable Drugs·2 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Aven...
Injectable Drugs·1 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
Morphine Sulf inhalation, 5mg/3cc, 3cc per vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Drugs·60 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
Dehydrated Alcohol Solution, packaged in a) 1 mL and b) 3 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette...
Drugs·2 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
DMSO 6.25% Opth Sol, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Drugs·1 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15...
Ophthalmic Drugs·1 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL vial, Rx onl...
Injectable Drugs·1 affected·Jul 25, 2018
High RiskFDA
Ranier's Compounding Laboratory
Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Drugs·5 affected·Jul 25, 2018
High RiskFDA
Trilliant Surgical, Llc
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model...
Surgical Devices·170 affected·Jul 19, 2018
High RiskFDA
Trilliant Surgical, Llc
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-10...
Surgical Devices·8 affected·Jul 19, 2018
High RiskFDA
Beaver Visitec
Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intende...
Medical Devices·800 affected·Jul 19, 2018
High RiskFDA
Trilliant Surgical, Llc
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112...
Medical Implants·4 affected·Jul 19, 2018
High RiskFDA
Trilliant Surgical, Llc
Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-...
Medical Implants·4 affected·Jul 19, 2018
High RiskFDA
Trilliant Surgical, Llc
Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw Sys...
Surgical Devices·4 affected·Jul 19, 2018
High RiskFDA
Kerr/pentron, Dba Kerr Corporation And Pentron Clinical
Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
Medical Devices·31,904 affected·Jul 13, 2018
High RiskFDA
Covidien Llc
400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
Medical Devices·27,515 affected·Jul 11, 2018
High RiskFDA
Covidien Llc
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
Medical Devices·27,515 affected·Jul 11, 2018
High RiskFDA
Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, ...
Surgical Devices·5,507 affected·Jul 10, 2018
High RiskFDA
Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, ...
Surgical Devices·7,024 affected·Jul 10, 2018
High RiskFDA
Merit Medical Systems, Inc.
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non...
Medical Devices·6 affected·Jul 9, 2018
High RiskFDA
Neotract Inc
UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By:...
Medical Devices·8,804 affected·Jul 6, 2018
CriticalFDA
Fagron Compounding Services Llc Dba Fagron Sterile Services
Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron...
Injectable Drugs·840 affected·Jun 29, 2018
CriticalFDA
Fagron Compounding Services Llc Dba Fagron Sterile Services
Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron...
Injectable Drugs·390 affected·Jun 29, 2018