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
Mrp, Llc Dba Amusa
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 ...
Medical Devices·1,080 affected·Feb 9, 2015
High RiskFDA
Zipline Medical
Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incisio...
Surgical Devices·3,109 affected·Feb 5, 2015
High RiskFDA
Microport Orthopedics Inc.
EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics...
Medical Implants·17 affected·Feb 2, 2015
High RiskFDA
Anazaohealth Corporation
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl ...
Injectable Drugs·51 affected·Jan 26, 2015
High RiskFDA
Halyard Health
KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Medical Devices·5 affected·Jan 16, 2015
High RiskFDA
Halyard Health
KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Medical Devices·5 affected·Jan 16, 2015
High RiskFDA
Halyard Health
KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Medical Devices·83 affected·Jan 16, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intui...
Surgical Devices·1,034 affected·Jan 15, 2015
High RiskFDA
Medtronic Sofamor Danek Usa Inc
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation...
Medical Devices·239 affected·Jan 13, 2015
High RiskFDA
Teleflex Medical
LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway du...
Respiratory Devices·2,640 affected·Jan 13, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE, Rx ONLY --- For single use only. --- Device Li...
Medical Devices·602 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211, STERILE, Rx ONLY --- For single use only. Device Li...
Medical Devices·133 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 60150692, STERILE, Rx ONLY --- For single use only. --- Device L...
Medical Devices·22 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·1 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·74 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706, STERILE, Rx ONLY --- For single use only. --- Device...
Cardiac Devices·489 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE, Rx ONLY ---For single use only. --- Device Li...
Medical Devices·30 affected·Jan 9, 2015
High RiskFDA
Teleflex Medical
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
Medical Devices·300 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 60220746, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·17 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·2,502 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131, REF/Catalog No. 60040313, STERILE, Rx ONLY --- --- Fo...
Medical Devices·438 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185252, STERILE, Rx ONLY --- For single use only. --- Device Li...
Medical Devices·7 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, Rx ONLY --- For single use only. --- Device Listing Numbe...
Medical Devices·390 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D1...
Medical Devices·238 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE, Rx ONLY --- For single use only. --- Device Listing Numbe...
Medical Devices·124 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710, STERILE, Rx ONLY --- For single use only. --- Devic...
Cardiac Devices·5 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No. 60041921, STERILE, Rx ONLY --- For single use only. --- De...
Medical Devices·16 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog No. 60010512, STERILE, Rx ONLY --- For single use only. Dev...
Medical Devices·19 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE, Rx ONLY --- For single use only. --- Device Listing Number...
Medical Devices·1,008 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE, Rx ONLY --- For single use only. Device Listing Number D13...
Medical Devices·4 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. ...
Medical Devices·2 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 60232234, STERILE, Rx ONLY --- For single use only. --- Device ...
Cardiac Devices·61 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·1 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·541 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·69 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·13 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·20 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412, STERILE, Rx ONLY ---For single use only. --- Device Lis...
Cardiac Devices·2,409 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only. --- Device List...
Medical Devices·70 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No. 600801020, STERILE, Rx ONLY ---For single use only. ---...
Cardiac Devices·105 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY --- For single use only. --- Device Listing Numbe...
Medical Devices·161 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 60150672, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·5 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801, STERILE, Rx ONLY --- For single use only. --- Device...
Cardiac Devices·562 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 60160535, STERILE, Rx ONLY --- For single use only. --- Device ...
Cardiac Devices·2 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D...
Medical Devices·136 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE, Rx ONLY --- For single use only. --- Device Lis...
Medical Devices·10 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60101162, STERILE, Rx ONLY ---For single use only. --- Device ...
Medical Devices·1 affected·Jan 9, 2015
High RiskFDA
Navilyst Medical, Inc
NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 60012591, STERILE, Rx ONLY ---For single use only. --- Device L...
Cardiac Devices·2 affected·Jan 9, 2015