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
Tecfen Medical
Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product...
Medical Devices·47 affected·Apr 25, 2025
High RiskFDA
Brs Analytical Services, Llc
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 F...
Ophthalmic Drugs·13,872 affected·Apr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile...
Topical Drugs·1,610 affected·Apr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed ...
Ophthalmic Drugs·14,333 affected·Apr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moist...
Ophthalmic Drugs·13,104 affected·Apr 23, 2025
High RiskFDA
Brs Analytical Services, Llc
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturi...
Ophthalmic Drugs·32,876 affected·Apr 23, 2025
High RiskFDA
Mozarc Medical Us Llc
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Surgical Devices·95,938 affected·Apr 23, 2025
High RiskFDA
Mozarc Medical Us Llc
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Surgical Devices·95,938 affected·Apr 23, 2025
High RiskFDA
Mozarc Medical Us Llc
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Surgical Devices·95,938 affected·Apr 23, 2025
High RiskFDA
Mozarc Medical Us Llc
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Surgical Devices·95,938 affected·Apr 23, 2025
High RiskFDA
Fdc Limited
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharasht...
Ophthalmic Drugs·60,428 affected·Apr 18, 2025
High RiskFDA
American Regent, Inc.
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043...
Injectable Drugs·29,777 affected·Apr 18, 2025
High RiskFDA
American Regent, Inc.
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11...
Injectable Drugs·7,249 affected·Apr 18, 2025
High RiskFDA
Nubratori, Inc
Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative F...
Injectable Drugs·20 affected·Apr 15, 2025
High RiskFDA
Apollo Care, Llc
FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Steri...
Injectable Drugs·440 affected·Apr 15, 2025
High RiskFDA
Microtek Medical, Inc.
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Dr...
Medical Devices·2,024 affected·Apr 13, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Medical Devices·840 affected·Apr 9, 2025
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 8011...
Drugs·16,655 affected·Mar 31, 2025
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters ...
Drugs·23,610 affected·Mar 31, 2025
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC...
Drugs·170 affected·Mar 31, 2025
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC:...
Drugs·49,830 affected·Mar 31, 2025
High RiskFDA
Denver Solutions, Llc Dba Leiters Health
PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark ...
Drugs·7,290 affected·Mar 31, 2025
High RiskFDA
Belmont Instrument Llc
Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The ...
Medical Devices·158 affected·Mar 31, 2025
High RiskFDA
Galt Medical Corporation
GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and oth...
Surgical Devices·100 affected·Mar 27, 2025
High RiskFDA
Galt Medical Corporation
B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intend...
Surgical Devices·1,400 affected·Mar 27, 2025
High RiskFDA
Galt Medical Corporation
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer Syst...
Surgical Devices·100 affected·Mar 27, 2025
CriticalFDA
Avanos Medical, Inc.
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description...
Surgical Devices·0 affected·Mar 19, 2025
CriticalFDA
Avanos Medical, Inc.
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Balla...
Surgical Devices·1,980 affected·Mar 19, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
Medical Devices·30 affected·Mar 19, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL...
Medical Devices·822 affected·Mar 19, 2025
CriticalFDA
Avanos Medical, Inc.
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Bal...
Surgical Devices·9,960 affected·Mar 19, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Medical Devices·2,519,991 affected·Mar 19, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Sterile Water, USP, 100mL, REF RDI30295
Medical Devices·963,054 affected·Mar 19, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
Medical Devices·2,220 affected·Mar 19, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Medical Devices·1,655 affected·Mar 14, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILE...
Medical Implants·7,453 affected·Mar 14, 2025
CriticalFDA
Conavi Medical Inc.
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Comm...
Surgical Devices·685 affected·Mar 12, 2025
High RiskFDA
Exela Pharma Sciences Llc
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx On...
Injectable Drugs·103,950 affected·Mar 7, 2025
High RiskFDA
Quva Pharma, Inc.
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injectio...
Injectable Drugs·2,310 affected·Mar 6, 2025
High RiskFDA
Quva Pharma, Inc.
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for...
Injectable Drugs·0 affected·Mar 6, 2025
High RiskFDA
Quva Pharma, Inc.
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for...
Injectable Drugs·1,765 affected·Mar 6, 2025
High RiskFDA
Cordis Us Corp
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Medical Implants·20 affected·Mar 4, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
Medical Devices·6 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Refer to RES
Medical Devices·11,889 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
Medical Devices·48 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, M...
Medical Devices·530 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
Medical Devices·60 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PAC...
Medical Devices·21,935 affected·Mar 3, 2025