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
Pentec Health
Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) ...
Drugs·3 affected·May 15, 2013
High RiskFDA
Pentec Health
Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc.,...
Drugs·4 affected·May 15, 2013
High RiskFDA
Pentec Health
Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pen...
Drugs·38 affected·May 15, 2013
High RiskFDA
Pentec Health
Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, P...
Drugs·25 affected·May 15, 2013
High RiskFDA
Pentec Health
IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pent...
Drugs·3 affected·May 15, 2013
High RiskFDA
Pentec Health
Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 ...
Drugs·59 affected·May 15, 2013
High RiskFDA
Pentec Health
Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec He...
Drugs·9 affected·May 15, 2013
High RiskFDA
Baxter Healthcare Corp.
Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) ...
Medical Devices·530,488 affected·May 15, 2013
High RiskFDA
Baxter Healthcare Corp.
Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: ...
Medical Devices·356,728 affected·May 15, 2013
High RiskFDA
Baxter Healthcare Corp.
Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) ...
Medical Devices·249,576 affected·May 15, 2013
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric...
Medical Devices·100 affected·May 14, 2013
CriticalFDA
Abrams Royal Pharmacy
Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as ...
Injectable Drugs·21 affected·May 13, 2013
High RiskFDA
Zimmer Surgical Inc
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickn...
Medical Devices·126 affected·May 7, 2013
High RiskFDA
Zimmer Surgical Inc
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness ...
Medical Devices·84 affected·May 7, 2013
High RiskFDA
Zimmer Surgical Inc
Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable gr...
Medical Devices·13 affected·May 7, 2013
High RiskFDA
The Compounding Shop, Inc.
Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·1 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·43 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·56 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·32 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·1 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·80 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·4 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·7 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·3 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·78 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·2 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·44 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·1 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Drugs·5 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·55 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·20 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·41 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·2 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·1 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Pete...
Injectable Drugs·14 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·12 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·19 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Injectable Drugs·10 affected·May 2, 2013
High RiskFDA
The Compounding Shop, Inc.
Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg...
Injectable Drugs·4 affected·May 2, 2013
High RiskFDA
Hospira Inc.
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-234...
Injectable Drugs·44,748 affected·Apr 30, 2013
High RiskFDA
Angiodynamics, Inc.
AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog N...
Medical Devices·1,760 affected·Apr 30, 2013
High RiskFDA
American Optisurgical Inc
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Surgical Devices·63 affected·Apr 30, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration,
Drugs·2 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration,
Injectable Drugs·8 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration,
Drugs·0 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,
Injectable Drugs·0 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration,
Injectable Drugs·1 affected·Apr 22, 2013
High RiskFDA
Nora Apothecary And Alternative Therapies, Inc.
PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,
Injectable Drugs·0 affected·Apr 22, 2013