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
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs·952,100 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10...
Drugs·7,990,100 affected·Mar 19, 2021
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ...
Drugs·1,434,000 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ...
Drugs·14,275,400 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs·24,969,700 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3...
Drugs·40,720,900 affected·Mar 19, 2021
High RiskFDA
Sun Pharmaceutical Industries Inc
Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, ...
Injectable Drugs·91,211 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, I...
Injectable Drugs·341 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Ak...
Topical Drugs·424 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Pri...
Injectable Drugs·8 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by:...
Topical Drugs·31 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 1...
Ophthalmic Drugs·12 affected·Mar 15, 2021
High RiskFDA
Cardinal Health Inc.
Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Wort...
Ophthalmic Drugs·348 affected·Mar 15, 2021
High RiskFDA
Sagent Pharmaceuticals Inc
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intrave...
Injectable Drugs·3,716 affected·Mar 11, 2021
High RiskFDA
Krishe Inc
Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 50, Nasal Swab - 50 , Package Insert - 1, IVD, CE
Medical Devices·18,000 affected·Mar 11, 2021
High RiskFDA
Krishe Inc
Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
Medical Devices·10,000 affected·Mar 11, 2021
CriticalFDA
Pnhc, Llc.
heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL)...
Topical Drugs·139,806 affected·Mar 10, 2021
High RiskFDA
Roi Cps Llc
Regard, Item Number 830067009, custom cardiovascular procedure kit
Medical Devices·16 affected·Mar 4, 2021
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)1084...
Cardiac Devices·0 affected·Feb 26, 2021
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)1084...
Cardiac Devices·71,473 affected·Feb 26, 2021
High RiskFDA
Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)108...
Cardiac Devices·0 affected·Feb 26, 2021
High RiskFDA
Cardinal Health 200, Llc
In-View Clear Leggings Sterile
Medical Devices·28,417 affected·Feb 25, 2021
High RiskFDA
Trinity Sterile, Inc.
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dres...
Surgical Devices·2,970 affected·Feb 23, 2021
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction o...
Surgical Devices·337 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDT...
Surgical Devices·18 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:...
Surgical Devices·19 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:D...
Surgical Devices·13 affected·Feb 22, 2021
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access...
Medical Implants·267 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDT...
Surgical Devices·15 affected·Feb 22, 2021
High RiskFDA
Epix Therapeutics, Inc
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CE...
Surgical Devices·100 affected·Feb 22, 2021
High RiskFDA
The General Hospital Corporation
Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusett...
Injectable Drugs·50 affected·Feb 17, 2021
RecallFDA
Edge Pharma, Llc
Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercu...
Drugs·213 affected·Feb 17, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 1945...
Injectable Drugs·12,609 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tr...
Injectable Drugs·29,357 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx ...
Injectable Drugs·26,373 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-0...
Injectable Drugs·2,577 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-...
Injectable Drugs·50 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials...
Injectable Drugs·336,697 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (...
Injectable Drugs·5,086 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tr...
Injectable Drugs·5,378 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wale...
Injectable Drugs·4,806 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 1945...
Injectable Drugs·12,629 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA,...
Injectable Drugs·15,043 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals US...
Injectable Drugs·0 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Man...
Injectable Drugs·705,745 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 07...
Injectable Drugs·248,565 affected·Feb 10, 2021
High RiskFDA
Teva Pharmaceuticals Usa
MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), 5 mL Multiple-Dose Vial, Rx only, Teva Pharmaceuticals USA, ...
Injectable Drugs·6,710 affected·Feb 10, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reserv...
Respiratory Devices·14 affected·Feb 4, 2021