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
Sca Pharmaceuticals
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainb...
Drugs·23,029 affected·Dec 17, 2020
High RiskFDA
Sca Pharmaceuticals
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow...
Injectable Drugs·9,942 affected·Dec 17, 2020
High RiskFDA
Bioventus, Llc
EXOGEN Ultrasound Coupling Gel
Medical Devices·115,584 affected·Dec 17, 2020
High RiskFDA
Medtronic Neurosurgery
REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt ...
Medical Devices·0 affected·Dec 16, 2020
High RiskFDA
Medtronic Neurosurgery
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt ...
Medical Devices·0 affected·Dec 16, 2020
High RiskFDA
Cipla
Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited ...
Injectable Drugs·2,151 affected·Dec 14, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Surgical Devices·1,759 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Surgical Devices·247 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curv...
Surgical Devices·863 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/C...
Medical Devices·583 affected·Dec 10, 2020
High RiskFDA
Argon Medical Devices, Inc
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/C...
Medical Devices·187 affected·Dec 10, 2020
High RiskFDA
Shilpa Medicare Limited
Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic...
Injectable Drugs·2,064 affected·Dec 8, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a...
Surgical Devices·3,858 affected·Dec 8, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component o...
Surgical Devices·3,165 affected·Dec 8, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex Loss of Resistance Device, REF 100/398/000
Medical Devices·3,420 affected·Dec 8, 2020
High RiskFDA
Medtronic Neurosurgery
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of...
Surgical Devices·1,926 affected·Dec 8, 2020
High RiskFDA
Oto Med Inc
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a sucti...
Medical Devices·5,092 affected·Dec 7, 2020
High RiskFDA
Icu Medical, Inc.
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, steri...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single us...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·4 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·4 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·3 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·3 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·6 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Injectable Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·2 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·3 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
RecallUSDA
Producers Meat & Provision
Tarantino Wholesale Foods Distributor Recalls Ready-to-Eat Chicken Breast Products That May be Undercooked
Poultry·0 affected·Nov 26, 2020
High RiskFDA
Biomet, Inc.
3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 11000...
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, n...
Surgical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and inten...
Medical Implants·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including ost...
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of sm...
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
Medical Devices·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, M...
Medical Implants·7,428 affected·Nov 25, 2020
High RiskFDA
Biomet, Inc.
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180...
Medical Implants·7,428 affected·Nov 25, 2020