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
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pha...
Injectable Drugs·7,198 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 75...
Injectable Drugs·8,755 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pha...
Injectable Drugs·1,118 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Wi...
Injectable Drugs·500 affected·Nov 9, 2023
High RiskFDA
Sca Pharmaceuticals, Llc
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL US...
Injectable Drugs·242 affected·Nov 9, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduc...
Surgical Devices·2,551 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter int...
Surgical Devices·1 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0...
Surgical Devices·717 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter...
Surgical Devices·0 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter int...
Surgical Devices·3 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter...
Surgical Devices·1,784 affected·Nov 7, 2023
High RiskFDA
Abiomed, Inc.
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the b...
Surgical Devices·4 affected·Nov 7, 2023
High RiskFDA
Merit Medical Systems, Inc.
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC21...
Surgical Devices·717 affected·Nov 6, 2023
High RiskFDA
Merit Medical Systems, Inc.
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Surgical Devices·59 affected·Nov 6, 2023
CriticalFDA
Nurse Assist, Llc
0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203...
Medical Devices·61,740 affected·Nov 6, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE PVP SOLUTION, REF DYNDA1907
Medical Devices·8,250 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE POVIDONE, REF DYNDA2061
Medical Devices·300 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE BETADINE, REF DYNDA1998
Medical Devices·1,800 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE PVP, REF DYNDA1649
Medical Devices·700 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE STERILE PREP STICK, REF DYNDA1134
Medical Devices·240 affected·Nov 3, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Medical Devices·835 affected·Nov 1, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distribut...
Drugs·11,782 affected·Oct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropp...
Drugs·11,629 affected·Oct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distribute...
Ophthalmic Drugs·28,477 affected·Oct 31, 2023
CriticalFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC ...
Ophthalmic Drugs·1,271,810 affected·Oct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Healt...
Drugs·21,802 affected·Oct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, ...
Ophthalmic Drugs·8,784 affected·Oct 31, 2023
CriticalFDA
Cardinal Health Inc.
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardin...
Ophthalmic Drugs·119,871 affected·Oct 31, 2023
CriticalFDA
The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, ...
Ophthalmic Drugs·65,880 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Medical Implants·126 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Medical Implants·45 affected·Oct 31, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Medical Devices·59 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the b...
Medical Devices·1,639 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Medical Devices·173 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
Medical Devices·160 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
Medical Devices·173 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
Medical Devices·510 affected·Oct 19, 2023
CriticalFDA
Exela Pharma Sciences Llc
ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only,...
Injectable Drugs·38,200 affected·Oct 18, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14...
Drugs·9,673 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Drugs·4,972 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Ri...
Drugs·2,176 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Par...
Injectable Drugs·130 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawan...
Ophthalmic Drugs·1,598 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by...
Injectable Drugs·2,484 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Phar...
Ophthalmic Drugs·1,693 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Ton...
Ophthalmic Drugs·128 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmace...
Inhaled / Nasal Drugs·860 affected·Oct 2, 2023
High RiskFDA
Pine Pharmaceuticals, Llc
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkwa...
Drugs·881 affected·Oct 2, 2023