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
American Medical Systems Innovation Center - Silicon Valley
365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but no...
Surgical Devices·16 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endos...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
Musculoskeletal Transplant Foundation, Inc.
Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
Medical Devices·22 affected·May 27, 2015
High RiskFDA
Remel Inc
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorga...
Medical Devices·143 affected·May 19, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywoo...
Injectable Drugs·2 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·1 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Holl...
Injectable Drugs·28 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywoo...
Injectable Drugs·3 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood,...
Injectable Drugs·6 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·1 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·30 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·41 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 9...
Injectable Drugs·32 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·17 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA ...
Injectable Drugs·0 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Holly...
Injectable Drugs·416 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 9...
Injectable Drugs·21 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·2 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·1 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood...
Injectable Drugs·77 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA ...
Injectable Drugs·21 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
GLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·1 affected·May 18, 2015
High RiskFDA
Coreva Health Science Llc
ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated ...
Medical Devices·180,900 affected·May 18, 2015
High RiskFDA
Montana Compounding Pharmacy
Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
Drugs·20 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Miss...
Injectable Drugs·1 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·20 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·1 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·25 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·1 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.
Injectable Drugs·32 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·1 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT
Inhaled / Nasal Drugs·10 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·259 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·2 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·1 affected·May 15, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. ...
Surgical Devices·21 affected·May 12, 2015
High RiskFDA
Vidacare Corporation
T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corpora...
Medical Devices·2,104 affected·May 12, 2015
High RiskFDA
Advanced Sterilization Products
EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a ...
Medical Devices·44 affected·May 11, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabu...
Medical Implants·40 affected·May 6, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabul...
Medical Implants·12 affected·May 6, 2015
High RiskFDA
Smith & Nephew, Inc.
R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabul...
Medical Implants·0 affected·May 6, 2015
High RiskFDA
Smiths Medical Asd Inc
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX ...
Medical Devices·6,000 affected·May 4, 2015
CriticalFDA
Synovis Surgical Innovations, Inc.
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product cod...
Medical Devices·3,974 affected·May 2, 2015
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integ...
Medical Devices·123 affected·May 1, 2015
High RiskFDA
Beaver-visitec International Inc.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
Surgical Devices·214 affected·May 1, 2015
High RiskFDA
Beaver-visitec International Inc.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
Surgical Devices·621 affected·May 1, 2015
High RiskFDA
Beaver-visitec International Inc.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
Surgical Devices·384 affected·May 1, 2015
High RiskFDA
Beaver-visitec International Inc.
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
Surgical Devices·268 affected·May 1, 2015