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
Synthes (usa) Products Llc
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
Medical Devices2,157 affectedOct 3, 2016
High RiskFDA
Covidien Llc
Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number ...
Surgical Devices4,950 affectedSep 29, 2016
High RiskFDA
Thayer Medical Corporation
Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm D...
Respiratory Devices2,550 affectedSep 29, 2016
High RiskFDA
North American Rescue Llc.
Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
Drugs0 affectedSep 27, 2016
High RiskFDA
North American Rescue Llc.
Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue
Drugs0 affectedSep 27, 2016
High RiskFDA
North American Rescue Llc.
Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
Drugs0 affectedSep 27, 2016
High RiskFDA
North American Rescue Llc.
USCG Boat Response Kit - Product Code 80-0353, North American Rescue
Drugs0 affectedSep 27, 2016
High RiskFDA
North American Rescue Llc.
Aid Backpack Kit - Product Code 85-0917, North American Rescue
Drugs0 affectedSep 27, 2016
High RiskFDA
North American Rescue Llc.
Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue
Drugs0 affectedSep 27, 2016
High RiskFDA
North American Rescue Llc.
K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
Drugs0 affectedSep 27, 2016
High RiskFDA
North American Rescue Llc.
Range Trauma Kit - Product Code 85-1274, North American Rescue
Drugs0 affectedSep 27, 2016
High RiskFDA
North American Rescue Llc.
Amphibious Trauma Kit - Product Code 85-0639, North American Rescue
Drugs0 affectedSep 27, 2016
CriticalFDA
Guardian Pharmacy Services
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Drugs180 affectedSep 23, 2016
High RiskFDA
Merit Medical Systems, Inc.
Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
Medical Devices130 affectedSep 23, 2016
High RiskFDA
Cardinal Health 200, Llc
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
Medical Devices72,076 affectedSep 23, 2016
High RiskFDA
Merit Medical Systems, Inc.
Manifold Kit. Catalog Number K09-11867AP
Medical Devices40 affectedSep 23, 2016
High RiskFDA
Merit Medical Systems, Inc.
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Medical Devices53 affectedSep 23, 2016
High RiskFDA
Wells Pharmacy Network Llc
Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
Injectable Drugs24 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs1,165 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala FL
Injectable Drugs2,264 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs21 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Forskolin/PAPAV/PHEN/PGE1, 100 mcg/30 mcg/3 mcg/60 mcg/mL, 5 mL vial, Injectable, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs22 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Oca...
Injectable Drugs147 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs1,753 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Mitomycin 40 mg Injectable, Lyophilized (Buffered), 1 mL vial, Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs2,336 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Trimix Injectable 30 mg/2 mg/20 mcg, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs56 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
MIC/B-COMPLEX 15 mg/50 mg/100 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs984 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs4 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Testosterone Cypionate in Sesame Oil Injectable 200 mg/mL, a) 1 mL and b) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs798 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable, 75 mg/75 mg/150 mg/150 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs199 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs9 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
QUAD3 (PAP/PHEN/ALPRO/ATRO) 30 mg/3 mg/30 mcg/0.1mL Injectable, a) 2 mL and 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs1,312 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs176 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs1,638 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Vitamin D3 in Sesame Oil Injectable 100,000 IU/mL, 5 mL, vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs237 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Sodium Bicarbonate, 8.4% Injectable, 30 mL MultiDose vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs67 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs3 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs1,319 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs41 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs44 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Trimix Injectable 30 mg/1 mg/25 mcg/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs7 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
ULTRA-TEST (CYP 80%/PROP 20%) Injectable, 250 mg/mL 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs157 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
MIC Combo - Standard 15 mg/50 mg/100 mg/mL Injectable, 30 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs308 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Sermorelin Acetate/GHRP (6) 3 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs106 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy, Ocala , FL
Ophthalmic Drugs46 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
TitanMax-MIC/12/CA/CH/L/D Injectable 25 mg/50 mg/50/0.5 mg/50 mg/25 mcg/25 mg/25 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs18 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Sermorelin Acetate/GHRP (2) & (6) 9 mg/3.15 mg/3.15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs3,089 affectedSep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Inositol/Choline/B-Complex+Leucine+CARN+CHROM+LIDO (LipoLean), Injectable, 30 mL vial, Compounded by Wells Pharmacy. Ocala, FL
Injectable Drugs433 affectedSep 21, 2016