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
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 ...
Medical Implants·7 affected·Jul 27, 2012
High RiskFDA
Stryker Orthobiologics, Inc.
Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare ...
Surgical Devices·3,268 affected·Jul 26, 2012
High RiskFDA
Custom Medical Specialties, Inc.
CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialt...
Drugs·25 affected·Jul 23, 2012
High RiskFDA
Custom Medical Specialties, Inc.
CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 3...
Drugs·20 affected·Jul 23, 2012
High RiskFDA
Custom Medical Specialties, Inc.
Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 12...
Drugs·35 affected·Jul 23, 2012
RecallFDA
Trek Diagnostic Systems
VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a s...
Medical Devices·333 affected·Jul 23, 2012
CriticalFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC...
Respiratory Devices·337,227 affected·Jul 18, 2012
High RiskFDA
Lucero Medical Llc
Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thora...
Medical Devices·169 affected·Jul 15, 2012
High RiskFDA
Zimmer, Inc.
The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporar...
Medical Implants·24 affected·Jul 13, 2012
High RiskFDA
Kimberly-clark Corporation
MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect...
Surgical Devices·933 affected·Jul 5, 2012
High RiskFDA
Kimberly-clark Corporation
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical...
Surgical Devices·89,856 affected·Jul 5, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usa...
Medical Devices·4,411 affected·Jul 3, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: ...
Medical Devices·4,661 affected·Jul 3, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product...
Medical Devices·2,204 affected·Jul 3, 2012
High RiskFDA
C.r. Bard, Inc., Urological Division
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for s...
Surgical Devices·56,694 affected·Jun 29, 2012
High RiskFDA
Bridgepoint Medical
BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Me...
Medical Implants·95 affected·Jun 26, 2012
High RiskFDA
Molded Products Inc
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
Medical Devices·1,200 affected·Jun 19, 2012
RecallFDA
Advanced Sterilization Products
STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose steril...
Medical Devices·7,550 affected·Jun 19, 2012
RecallFDA
Advanced Sterilization Products
STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose ster...
Medical Devices·7,495 affected·Jun 19, 2012
High RiskFDA
Stryker Endoscopy
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distrib...
Surgical Devices·6,388 affected·Jun 19, 2012
RecallFDA
Stat Rx Usa
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16...
Ophthalmic Drugs·22 affected·Jun 18, 2012
High RiskFDA
Cardiovascular Systems, Inc.
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxid...
Medical Devices·27 affected·Jun 18, 2012
RecallFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs ...
Medical Devices·4 affected·Jun 7, 2012
High RiskFDA
Zimmer, Inc.
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non steri...
Medical Implants·249 affected·Jun 5, 2012
High RiskFDA
Zimmer, Inc.
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non steril...
Surgical Devices·249 affected·Jun 5, 2012
High RiskFDA
Bracco Diagnostics Inc
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactur...
Drugs·54 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656...
Surgical Devices·40 affected·Jun 1, 2012
High RiskFDA
Advanced Sterilization Products
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended...
Medical Devices·1,310,844 affected·Jun 1, 2012
High RiskFDA
Psc Industries Inc
Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Ea...
Surgical Devices·125 affected·Jun 1, 2012
Medium RiskFDA
Bayer Healthcare Pharmaceuticals Inc.
Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98...
Injectable Drugs·138,505 affected·May 31, 2012
High RiskFDA
Biomet 3i, Llc
Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed...
Medical Devices·611 affected·May 31, 2012
High RiskFDA
Maquet Inc.
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 ...
Medical Devices·20 affected·May 29, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPROSTADIL 15MCG/ML INJECTABLE 5 ML; ALPROSTADIL 20MCG/ML INJE...
Injectable Drugs·529 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, 0.95 ML, 1.25 ML (3 DIFFERENT PRODUCTS)
Injectable Drugs·4 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 PRODUCT)
Ophthalmic Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML; EPIINEPHRINE P.F. (SU...
Injectable Drugs·33 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PRODUCT)
Injectable Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML; ATROPINE/EPINEPHRINE/ BSS 0.02MG/0.1MG/ML INJECTABLE 10 ML,...
Injectable Drugs·32 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT)
Injectable Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, ...
Injectable Drugs·197 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS)
Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROXOCOBALAMIN**(VIT B-12) 1000MCG/ML INJECTABLE 30 ML Injectable (4 DIFFERENT PRODUCTS)
Injectable Drugs·7 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM; ACYCLOVIR OPHTHALMIC 3% SOLUTION 5 ML (2 DIFFERENT PRODUCTS)
Topical Drugs·3 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML (6 DIFFERENT PRODUCTS)
Injectable Drugs·17 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 120MG/1.8MCG/ML INTRATHECAL 10 ML; HYDROMO...
Drugs·7 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 0.2% OPHTHALMIC 10 ML; CYCLOSPORI...
Ophthalmic Drugs·40 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DEXAMETHASONE/BACTERIOSTATIC WATER IONTOPHORESIS 0.5MG/5ML(0.1MG/ML) INJECTABL 30 ML (1 PRODUCT) ...
Injectable Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT)
Drugs·2 affected·May 25, 2012