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
Tri-coast Pharmacy
Dexpanthenol 250 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
Drugs·5 affected·Nov 17, 2016
High RiskFDA
Tri-coast Pharmacy
Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/Lidocaine HCL 10 m...
Drugs·10 affected·Nov 17, 2016
High RiskFDA
Tri-coast Pharmacy
L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
Drugs·41 affected·Nov 17, 2016
High RiskFDA
Tri-coast Pharmacy
HCG 11,000 IU Vial. Compounded by Tri-Coast Pharmacy
Drugs·5,229 affected·Nov 17, 2016
High RiskFDA
Tri-coast Pharmacy
HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.
Drugs·4,884 affected·Nov 17, 2016
High RiskFDA
Tri-coast Pharmacy
Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/ml. Compounded by Tri-Coast Pharmacy.
Drugs·105 affected·Nov 17, 2016
High RiskFDA
Tri-coast Pharmacy
Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 m...
Drugs·59 affected·Nov 17, 2016
High RiskFDA
Smith & Nephew, Inc.
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Medical Devices·4,444 affected·Nov 16, 2016
High RiskFDA
Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Dev...
Surgical Devices·14 affected·Nov 15, 2016
High RiskFDA
Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Li...
Surgical Devices·82 affected·Nov 15, 2016
RecallUSDA
Schnuck Markets, Inc. Slnp
Schnuck Markets Inc. Recalls Ready-To-Eat Chicken Breast Products That May Be Undercooked
Poultry·0 affected·Nov 12, 2016
High RiskFDA
Halyard Health
Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
Medical Devices·59 affected·Nov 10, 2016
High RiskFDA
Sandoz Inc
L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per ...
Injectable Drugs·33,624 affected·Nov 9, 2016
High RiskFDA
Sandoz Inc
L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials p...
Injectable Drugs·18,751 affected·Nov 9, 2016
High RiskFDA
Elana, Inc.
Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated fo...
Surgical Devices·4 affected·Nov 9, 2016
High RiskFDA
Wright Medical Technology, Inc.
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Medical Devices·19 affected·Nov 8, 2016
High RiskFDA
Teleflex Medical
ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone bio...
Medical Devices·0 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
Medical Devices·66 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
SWANSON FINGER JOINT #1, Part Number 4700001
Medical Devices·20 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
INBONE STEM, TIBIAL, TOP, Part Number 200011901
Medical Devices·65 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001
Medical Devices·42 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
Medical Devices·30 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
SWANSON TRAPEZIUM IMPLANT, Part Number 4520002
Medical Implants·20 affected·Nov 8, 2016
High RiskFDA
Wright Medical Technology, Inc.
SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
Medical Devices·30 affected·Nov 8, 2016
High RiskFDA
Hospira Inc.
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-40...
Injectable Drugs·797,800 affected·Nov 1, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Medical Devices·84 affected·Nov 1, 2016
High RiskFDA
Spectranetics Corporation
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative oc...
Medical Devices·873 affected·Oct 31, 2016
High RiskFDA
Spectranetics Corporation
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 Th...
Surgical Devices·14,624 affected·Oct 31, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the...
Surgical Devices·5,055 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the ...
Surgical Devices·4,836 affected·Oct 26, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the c...
Surgical Devices·1,617 affected·Oct 26, 2016
High RiskFDA
Beckman Coulter Inc.
MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility ...
Medical Devices·131 affected·Oct 25, 2016
High RiskFDA
Micromedics, Inc.
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Surgical Devices·273 affected·Oct 20, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
Medical Devices·1,129 affected·Oct 19, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
Medical Devices·52,084 affected·Oct 19, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Medical Devices·62 affected·Oct 19, 2016
High RiskFDA
Ultroid Technologies, Inc.
Ultroid Sterile Disposable Probes sold individually
Medical Devices·7,784 affected·Oct 19, 2016
High RiskFDA
Pharmedium Services, Llc
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
Drugs·1,550 affected·Oct 12, 2016
High RiskFDA
Baxter Healthcare Corp.
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a s...
Medical Devices·22,656 affected·Oct 12, 2016
High RiskFDA
Par Pharmaceutical, Inc.
Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed ...
Ophthalmic Drugs·182,856 affected·Oct 5, 2016
RecallCPSC
Hobby Lobby, Walmart And Other Stores Nationwide And Online At Amazon.com And Shopsargentart.com From May 2015 To June 2016 For Between $1 And $8.
Sargent Art Recalls Craft Paints Due to Risk of Exposure to Bacteria
Consumer Products·2 affected·Oct 4, 2016
High RiskFDA
Medtronic
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to...
Medical Devices·230 affected·Oct 4, 2016
High RiskFDA
Medtronic
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedure...
Medical Devices·1,293,169 affected·Oct 4, 2016
High RiskFDA
Synthes (usa) Products Llc
Extraction Hook - Sterile for TI Cannulated Nails
Medical Devices·114 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Medical Devices·319 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
3.0 mm Reaming Rod/950 mm, Sterile
Medical Devices·887 affected·Oct 3, 2016
CriticalFDA
Medtronic Neuromodulation
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Visi...
Medical Implants·22,298 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
Medical Devices·139 affected·Oct 3, 2016