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
Apothecary Shoppe
Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
Injectable Drugs·3,540 affected·Sep 6, 2013
High RiskFDA
University Compounding Pharmacy
Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Injectable Drugs·965 affected·Sep 6, 2013
High RiskFDA
Small Bone Innovations, Inc.
Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Coll...
Medical Implants·2,036 affected·Sep 6, 2013
High RiskFDA
Northern New England Compounding Pharmacy Llc
Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561
Drugs·1 affected·Sep 5, 2013
High RiskFDA
Hospira Inc.
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045
Drugs·187,150 affected·Sep 5, 2013
High RiskFDA
Zimmer, Inc.
Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used wit...
Medical Devices·2,632 affected·Aug 28, 2013
High RiskFDA
Zimmer, Inc.
VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for tota...
Medical Devices·12,866 affected·Aug 28, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, T...
Medical Devices·16 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 381...
Medical Devices·46 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38...
Medical Devices·80 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38...
Medical Devices·45 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 3...
Medical Devices·8 affected·Aug 27, 2013
High RiskFDA
Pharmacy Creations
Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.
Injectable Drugs·50 affected·Aug 26, 2013
High RiskFDA
Pharmacy Creations
EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869
Injectable Drugs·75 affected·Aug 26, 2013
High RiskFDA
Biomet 3i, Llc
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***Bell...
Medical Implants·10,454 affected·Aug 26, 2013
High RiskFDA
Zimmer, Inc.
Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endi...
Medical Devices·14 affected·Aug 26, 2013
High RiskFDA
Walgreens Co
Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreen...
Injectable Drugs·298 affected·Aug 23, 2013
High RiskFDA
South Coast Specialty Compounding, Inc.
Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After D...
Injectable Drugs·82 affected·Aug 23, 2013
High RiskFDA
South Coast Specialty Compounding, Inc.
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
Injectable Drugs·297 affected·Aug 23, 2013
High RiskFDA
South Coast Specialty Compounding, Inc.
Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA
Injectable Drugs·117 affected·Aug 23, 2013
High RiskFDA
Ebi, Llc
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and ...
Medical Devices·7,092 affected·Aug 22, 2013
High RiskFDA
Hospira Inc.
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL...
Injectable Drugs·72,300 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chlorid...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Ch...
Medical Devices·3,235,860 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chlo...
Medical Devices·330,120 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chlori...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chlorid...
Medical Devices·0 affected·Aug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chlor...
Medical Devices·0 affected·Aug 16, 2013
CriticalFDA
Medline Industries, Inc.
STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgic...
Surgical Devices·10 affected·Aug 14, 2013
CriticalFDA
Medline Industries, Inc.
STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgic...
Surgical Devices·5 affected·Aug 14, 2013
CriticalFDA
Medline Industries, Inc.
STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com ...
Surgical Devices·10 affected·Aug 14, 2013
High RiskFDA
Teva Pharmaceuticals Usa, Inc.
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Injectable Drugs·780 affected·Aug 13, 2013
High RiskFDA
Hospira, Inc.
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01
Drugs·345,800 affected·Aug 12, 2013
High RiskFDA
Microaire Surgical Instruments, Llc
Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled i...
Medical Implants·15,786 affected·Aug 12, 2013
High RiskFDA
Deroyal Industries Inc
DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE...
Surgical Devices·726 affected·Aug 12, 2013
High RiskFDA
Specialty Compounding, Llc
All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
Drugs·0 affected·Aug 9, 2013
High RiskFDA
Varian Medical Systems, Inc.
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL130110...
Medical Devices·3 affected·Aug 9, 2013
High RiskFDA
Teleflex Medical
Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in ...
Medical Implants·8,220 affected·Aug 8, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
Medical Devices·18,919 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor
Medical Devices·4,452 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor
Medical Devices·725 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
Medical Devices·5,873 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Bio...
Medical Devices·2,038 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
Medical Devices·17,696 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor
Medical Devices·10,296 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
Medical Devices·1,308 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
Medical Devices·6,373 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor
Medical Devices·0 affected·Aug 6, 2013