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
Tailstorm Health Inc
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Pres...
Injectable Drugs·4,875 affected·Jun 2, 2025
High RiskFDA
Apotex Corp.
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufa...
Ophthalmic Drugs·87,840 affected·May 28, 2025
High RiskFDA
Apotex Corp.
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for...
Ophthalmic Drugs·105,456 affected·May 28, 2025
High RiskFDA
Apotex Corp.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Onta...
Ophthalmic Drugs·6,288 affected·May 28, 2025
High RiskFDA
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-3...
Injectable Drugs·3,651,468 affected·May 27, 2025
High RiskFDA
Jewel Precision Sheet Metal & Machining Co, Inc.
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Medical Devices·1 affected·May 23, 2025
CriticalFDA
Integra Lifesciences Corp. (neurosciences)
Extended Tip Applicator, 15 CM, Box of 5.
Medical Devices·2,524 affected·May 22, 2025
CriticalFDA
Integra Lifesciences Corp. (neurosciences)
Extended Tip Applicator, 8CM, Box of 5.
Medical Devices·6,216 affected·May 22, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Drugs·164 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Injectable Drugs·4 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englew...
Injectable Drugs·216 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Injectable Drugs·5 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englew...
Drugs·16 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Injectable Drugs·24 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, ...
Injectable Drugs·242 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Drugs·32 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Injectable Drugs·60 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, ...
Drugs·102 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-...
Injectable Drugs·64 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewo...
Injectable Drugs·28 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Injectable Drugs·826 affected·May 21, 2025
High RiskFDA
Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado)
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englew...
Drugs·16 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Surgical Devices·50 affected·May 21, 2025
High RiskFDA
Limacorporate S.p.a
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Medical Devices·9 affected·May 19, 2025
High RiskFDA
Drs Vascular, Inc
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vasc...
Medical Devices·264 affected·May 16, 2025
High RiskFDA
Therakos Development Limited
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Appl...
Medical Devices·5,826 affected·May 16, 2025
High RiskFDA
Contamac Solutions, Inc.
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Medical Devices·17,273 affected·May 15, 2025
High RiskFDA
Bd Switzerland Sarl
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Medical Devices·1,655,300 affected·May 12, 2025
High RiskFDA
Bd Switzerland Sarl
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, R...
Medical Devices·1,265,400 affected·May 12, 2025
High RiskFDA
Bd Switzerland Sarl
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Medical Devices·1,006,512 affected·May 12, 2025
High RiskFDA
Alembic Pharmaceuticals Limited
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 079...
Ophthalmic Drugs·0 affected·May 7, 2025
High RiskFDA
Medtronic Minimed, Inc.
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Medical Devices·1,440 affected·May 7, 2025
High RiskFDA
Empower Clinic Services, Llc Dba Empower Pharmacy
Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam ...
Injectable Drugs·8,230 affected·May 2, 2025
High RiskFDA
Cardinal Health 200, Llc
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Surgical Devices·370 affected·May 2, 2025
High RiskFDA
Cardinal Health 200, Llc
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Surgical Devices·1,710 affected·May 2, 2025
High RiskFDA
Copan Italia
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Diagnostic Devices·81,600 affected·May 2, 2025
High RiskFDA
Implant Direct Sybron Manufacturing Llc
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitat...
Medical Devices·45 affected·May 1, 2025
High RiskFDA
Alcon Research Llc
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - Se...
Surgical Devices·198,205 affected·Apr 28, 2025
High RiskFDA
Tecfen Medical
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product...
Medical Devices·26 affected·Apr 25, 2025
High RiskFDA
Tecfen Medical
Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No softw...
Medical Devices·42 affected·Apr 25, 2025
High RiskFDA
Tecfen Medical
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Des...
Medical Devices·1,400 affected·Apr 25, 2025