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
Boston Scientific Corporation
JAGTOME RX 39-30-260-025 Material Number: M00573100
Medical Devices·1,447 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 39-20-450-025 Material Number: M00573090
Medical Devices·367 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
Medical Devices·7,115 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 49-20MM/260CM Material Number: M00584000
Medical Devices·982 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 49-30MM/450CM Material Number: M00584030
Medical Devices·32 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 49-20-260-035 Material Number: M00573000
Medical Devices·101 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 44-30MM/450CM Material Number: M00584070
Medical Devices·142 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
Medical Devices·3,330 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
Medical Devices·500 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
HYDRATOME RX 44-20MM/260CM Material Number: M00583040
Medical Devices·7,695 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 49-30MM/260CM Material Number: M00584010
Medical Devices·472 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
Medical Devices·1,811 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
HYDRATOME RX 49-30MM/260CM Material Number: M00583010
Medical Devices·0 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M0057544...
Medical Devices·0 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 44-30-260-035 Material Number: M00573060
Medical Devices·2,209 affected·Dec 22, 2021
High RiskFDA
Ideal Specialty Apothecary, Inc. Dba Ideal Pharmacy
Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union,...
Injectable Drugs·57,994 affected·Dec 21, 2021
High RiskFDA
Nobel Biocare Usa Llc
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Medical Devices·702 affected·Dec 17, 2021
High RiskFDA
Smith & Nephew, Inc.
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic...
Surgical Devices·271 affected·Dec 14, 2021
High RiskFDA
Collagen Matrix, Inc.
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Medical Devices·68 affected·Dec 13, 2021
High RiskFDA
Mallinckrodt Pharmaceuticals Ireland Ltd
THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
Medical Devices·3 affected·Dec 10, 2021
High RiskFDA
Technomed Europe
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Medical Devices·117,672 affected·Dec 8, 2021
High RiskFDA
Edge Pharma, Llc
Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edg...
Topical Drugs·80 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge ...
Topical Drugs·0 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, ...
Injectable Drugs·199 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesica...
Drugs·627 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single...
Injectable Drugs·323 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colche...
Injectable Drugs·6,535 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthal...
Topical Drugs·1,773 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules ...
Injectable Drugs·8,140 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe...
Injectable Drugs·2,750 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical ...
Topical Drugs·163 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe...
Injectable Drugs·860 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Mul...
Topical Drugs·40 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-fil...
Injectable Drugs·749 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Her...
Injectable Drugs·30 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-f...
Injectable Drugs·1,825 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syri...
Injectable Drugs·2,568 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Us...
Topical Drugs·2,463 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edg...
Injectable Drugs·4,465 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercule...
Injectable Drugs·160 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular...
Injectable Drugs·1,720 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topica...
Topical Drugs·154 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic U...
Topical Drugs·363 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules ...
Injectable Drugs·309 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colches...
Drugs·860 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single U...
Topical Drugs·2,562 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colc...
Injectable Drugs·3,747 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit in...
Drugs·1,007 affected·Dec 6, 2021