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
Resource Optimization & Innovation Llc
Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
Medical Devices·288 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn
Medical Devices·430 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
Medical Devices·40 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn
Medical Devices·162 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa
Medical Devices·180 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa
Medical Devices·70 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
Cardiac Devices·30 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn
Medical Devices·1,056 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn
Medical Devices·1,224 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa
Medical Devices·55 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa
Medical Devices·148 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU
Medical Devices·14 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper
Medical Devices·10 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn
Cardiac Devices·228 affected·Jan 9, 2017
High RiskFDA
C2 Therapeutics, Inc.
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected p...
Surgical Devices·755 affected·Jan 6, 2017
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured,...
Medical Implants·619 affected·Jan 3, 2017
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to ...
Surgical Devices·619 affected·Jan 3, 2017
High RiskFDA
Allen Medical Systems, Inc.
Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is int...
Surgical Devices·112 affected·Jan 3, 2017
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wan...
Medical Devices·320 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable w...
Medical Devices·252 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable w...
Medical Devices·499 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wan...
Medical Devices·185 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wan...
Medical Devices·10 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable w...
Medical Devices·996 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wan...
Medical Devices·155 affected·Dec 28, 2016
High RiskFDA
Medtronic Advanced Energy, Llc
Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wan...
Medical Devices·275 affected·Dec 28, 2016
High RiskFDA
In2bones, Sas
NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticu...
Medical Devices·26 affected·Dec 19, 2016
High RiskFDA
Amgen, Inc.
AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufa...
Injectable Drugs·11,434 affected·Dec 15, 2016
High RiskFDA
Meta Pharmacy Services
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile c...
Ophthalmic Drugs·150 affected·Dec 15, 2016
High RiskFDA
Medline Industries Inc
14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction P...
Medical Devices·1,031 affected·Dec 14, 2016
High RiskFDA
Medline Industries Inc
16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distracti...
Medical Devices·198 affected·Dec 14, 2016
High RiskFDA
Medline Industries Inc
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction P...
Medical Devices·300 affected·Dec 14, 2016
High RiskFDA
Medline Industries Inc
16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distract...
Medical Devices·2,112 affected·Dec 14, 2016
CriticalFDA
Pacific Medical Solutions
Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
Drugs·0 affected·Dec 13, 2016
High RiskFDA
Medline Ind
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubri...
Diagnostic Devices·12,024 affected·Dec 12, 2016
High RiskFDA
Smiths Medical Asd Inc.
Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
Medical Devices·641,070 affected·Dec 9, 2016
High RiskFDA
Trilliant Surgical Ltd.
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fix...
Medical Devices·50 affected·Dec 8, 2016
High RiskFDA
Medacta Usa Inc
Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a conne...
Medical Devices·82 affected·Dec 7, 2016
High RiskFDA
Baxter Healthcare Corporation
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, De...
Injectable Drugs·30,910 affected·Dec 6, 2016
High RiskFDA
Acumed Llc
OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tr...
Medical Devices·83 affected·Dec 5, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Medical Devices·15 affected·Nov 30, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Expre...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Pa...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and P...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-l...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction con...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Oc...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control s...
Medical Devices·964,463 affected·Nov 29, 2016