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
Walgreens Infusion Services
3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·87 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 7823...
Injectable Drugs·30 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Injectable Drugs·1 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, Sa...
Supplements·30 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·19 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50 unit/0.5 mL, Rx Only, Compounded by Option Care 148,...
Drugs·23 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·23 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·63 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·26 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232...
Drugs·34 affected·Nov 10, 2015
High RiskFDA
Walgreens Infusion Services
Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Drugs·73 affected·Nov 10, 2015
High RiskFDA
Aesculap, Inc.
Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the ...
Medical Implants·37 affected·Nov 10, 2015
High RiskFDA
Aesculap, Inc.
Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantati...
Medical Implants·13 affected·Nov 10, 2015
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, ST...
Medical Implants·20 affected·Nov 9, 2015
High RiskFDA
Myco Medical Supplies Inc
Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
Medical Devices·2,401,419 affected·Nov 6, 2015
High RiskFDA
Medtronic Perfusion Systems
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and co...
Medical Devices·496 affected·Oct 28, 2015
High RiskFDA
Baylis Medical Corp *
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infus...
Surgical Devices·433 affected·Oct 28, 2015
High RiskFDA
Procedure Products, Inc.
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further proces...
Surgical Devices·1,100 affected·Oct 27, 2015
High RiskFDA
Arthrocare Corporation
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal pr...
Medical Devices·262 affected·Oct 26, 2015
High RiskFDA
Medtronic Vascular, Inc.
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210...
Surgical Devices·1,652 affected·Oct 23, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 1100...
Surgical Devices·1,139 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, ...
Surgical Devices·206 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with di...
Surgical Devices·54 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674...
Surgical Devices·508 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. ...
Surgical Devices·717 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and t...
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and ...
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and ...
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone ...
Medical Devices·9 affected·Oct 20, 2015
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone f...
Medical Devices·9 affected·Oct 20, 2015
High RiskFDA
Western Drug
Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Injectable Drugs·2 affected·Oct 19, 2015
High RiskFDA
Western Drug
Cantharitus Multi-Mix Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Drugs·1 affected·Oct 19, 2015
High RiskFDA
Western Drug
Podophyllum 40% Topical, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Topical Drugs·1 affected·Oct 19, 2015
High RiskFDA
Western Drug
Pyridoxine B6 100mg Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Drugs·3 affected·Oct 19, 2015
High RiskFDA
Western Drug
Dextrose 50% Inj Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Drugs·1 affected·Oct 19, 2015
High RiskFDA
Western Drug
Hydroxocobalamin 1mg Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Injectable Drugs·2 affected·Oct 19, 2015
High RiskFDA
Western Drug
Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Injectable Drugs·45 affected·Oct 19, 2015
High RiskFDA
Western Drug
Marcaine 0.24%/Ethanol 4% Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Injectable Drugs·5 affected·Oct 19, 2015
High RiskFDA
Western Drug
Tri-Mix LOW ED Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Injectable Drugs·1 affected·Oct 19, 2015
High RiskFDA
Western Drug
Calcium Chloride Dihydrate Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Injectable Drugs·1 affected·Oct 19, 2015
High RiskFDA
Western Drug
Progesterone Cyp Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Drugs·1 affected·Oct 19, 2015
High RiskFDA
Western Drug
Glutathione 300 mg/1.5 mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Injectable Drugs·1 affected·Oct 19, 2015
High RiskFDA
Western Drug
Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Injectable Drugs·9 affected·Oct 19, 2015