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
Sagent Pharmaceuticals Inc
Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag packaged in a foil overwrap, Rx only, Sterile, For Intraven...
Injectable Drugs·10,622 affected·Mar 4, 2014
High RiskFDA
Medtronic Vascular, Inc.
FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, St...
Surgical Devices·50 affected·Mar 3, 2014
High RiskFDA
Boston Scientific Corporation
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Surgical Devices·7 affected·Mar 3, 2014
High RiskFDA
Medtronic Vascular, Inc.
FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, St...
Surgical Devices·50 affected·Mar 3, 2014
High RiskFDA
Megadyne Medical Products, Inc.
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester pe...
Surgical Devices·494 affected·Feb 27, 2014
High RiskFDA
New England Home Therapies, Inc
All sterile drugs compounded between 2/21/14 and 2/24/14.
Drugs·87 affected·Feb 26, 2014
High RiskFDA
Zimmer, Inc.
Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE
Medical Devices·3,638 affected·Feb 25, 2014
High RiskFDA
Zimmer, Inc.
Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS ...
Medical Devices·3,638 affected·Feb 25, 2014
High RiskFDA
Zimmer, Inc.
Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CO...
Medical Implants·3,638 affected·Feb 25, 2014
High RiskFDA
Zimmer, Inc.
Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG T...
Medical Devices·3,638 affected·Feb 25, 2014
High RiskFDA
Zimmer, Inc.
Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1
Medical Devices·3,638 affected·Feb 25, 2014
High RiskFDA
Zimmer, Inc.
MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MO...
Medical Devices·3,638 affected·Feb 25, 2014
High RiskFDA
Zimmer, Inc.
Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5
Medical Devices·3,638 affected·Feb 25, 2014
High RiskFDA
Zimmer, Inc.
Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm
Medical Devices·3,638 affected·Feb 25, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged...
Medical Devices·137 affected·Feb 24, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hing...
Medical Devices·128 affected·Feb 24, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged...
Medical Devices·134 affected·Feb 24, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinge...
Medical Devices·129 affected·Feb 24, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hing...
Medical Devices·130 affected·Feb 24, 2014
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
Injectable Drugs·603,768 affected·Feb 11, 2014
CriticalFDA
Baxter Healthcare Corp.
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Dee...
Drugs·27,169 affected·Feb 11, 2014
High RiskFDA
Convatec Inc.
JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a...
Surgical Devices·31,250 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter ess...
Surgical Devices·4,760 affected·Feb 7, 2014
High RiskFDA
Biocardia, Inc.
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas,...
Surgical Devices·11 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter ...
Surgical Devices·54,590 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard ca...
Surgical Devices·5,540 affected·Feb 7, 2014
High RiskFDA
Convatec Inc.
Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters Th...
Surgical Devices·600 affected·Feb 7, 2014
High RiskFDA
Lin-zhi International Inc
Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as pot...
Diagnostic Devices·216 affected·Feb 6, 2014
High RiskFDA
Lin-zhi International Inc
Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as pot...
Diagnostic Devices·130 affected·Feb 6, 2014
High RiskFDA
Fisher Scientific Co
Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack F...
Medical Devices·7,430 affected·Feb 5, 2014
High RiskFDA
Innovative Sterlization Technologies Llc
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Medical Devices·2,104 affected·Feb 3, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrog...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) an...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethy...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is onl...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethy...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Smith & Nephew Inc
Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented...
Medical Implants·10 affected·Jan 23, 2014
High RiskFDA
Carefusion 303, Inc.
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. Th...
Medical Devices·3,500,000 affected·Jan 22, 2014
High RiskFDA
The Mentholatum Co.
ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum...
Ophthalmic Drugs·0 affected·Jan 16, 2014
High RiskFDA
The Mentholatum Co.
ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufact...
Ophthalmic Drugs·59 affected·Jan 16, 2014
High RiskFDA
The Mentholatum Co.
ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2,...
Ophthalmic Drugs·94,080 affected·Jan 16, 2014
High RiskFDA
The Mentholatum Co.
ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01074 9, Manufactu...
Ophthalmic Drugs·0 affected·Jan 16, 2014
High RiskFDA
Deroyal Industries Inc
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Medical Devices·2,504 affected·Jan 16, 2014
High RiskFDA
Zimmer, Inc.
00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabec...
Medical Implants·10 affected·Jan 10, 2014
High RiskFDA
Hospira Inc.
Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Ho...
Drugs·15,258 affected·Jan 9, 2014
High RiskFDA
Hospira Inc.
Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Fore...
Injectable Drugs·27,780 affected·Jan 9, 2014
High RiskFDA
Smith & Nephew Inc.
Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in ...
Medical Devices·7,353 affected·Jan 9, 2014
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable steri...
Medical Implants·46 affected·Jan 3, 2014