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
Altaire Pharmaceuticals, Inc.
Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA, Mfd. By: Altaire Ph...
Drugs·90,072 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville,...
Topical Drugs·469,128 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 634634, Product Size: 0.6 mL x 30, Distributed by: CVS Pharmacy, ...
Topical Drugs·114,504 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, Product Size: 0.6 mL x 24 ct, Distributed by: CVS Pharmacy, ...
Ophthalmic Drugs·58,704 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocke...
Topical Drugs·24,024 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, ...
Topical Drugs·0 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52
Topical Drugs·0 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., ...
Ophthalmic Drugs·483,528 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY 11931, NDC 59390-183-13
Drugs·22,494 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : Walgreen Co 200 Wilmot Road D...
Ophthalmic Drugs·43,008 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 7740...
Drugs·14,091 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perri...
Topical Drugs·1,737,549 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13
Drugs·48,542 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY ...
Ophthalmic Drugs·306,479 affected·Jul 2, 2019
High RiskFDA
Mazor Robotics Ltd
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Medical Devices·93 affected·Jul 2, 2019
High RiskFDA
Centurion Medical Products Corporation
DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for ...
Medical Devices·6,180 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient pop...
Medical Devices·3,250 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.
Medical Devices·220 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to faci...
Medical Devices·2,019,041,790 affected·Jul 1, 2019
High RiskFDA
Intuitive Surgical, Inc.
daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are i...
Surgical Devices·0 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.
Medical Devices·4,560 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general pa...
Medical Devices·1,900 affected·Jul 1, 2019
High RiskFDA
Intuitive Surgical, Inc.
daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are ...
Surgical Devices·22,752 affected·Jul 1, 2019
High RiskFDA
Teleflex Medical
Rusch EasyCath Kit
Medical Devices·3,700 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.
Medical Devices·120 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for genera...
Medical Devices·1,224 affected·Jul 1, 2019
High RiskFDA
Centurion Medical Products Corporation
HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient...
Medical Devices·192 affected·Jul 1, 2019
High RiskFDA
Medicrea International
Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7...
Medical Devices·210 affected·Jun 27, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509)...
Injectable Drugs·5 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Prostaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)10 mL vial, Rx only, First Pharma Associates dba Riverpoint P...
Injectable Drugs·2 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-...
Injectable Drugs·5 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, ...
Injectable Drugs·12 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b) 12 mL vials, Rx only, First Pharma Associates dba Riverpoi...
Injectable Drugs·18 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA...
Injectable Drugs·12 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 3...
Injectable Drugs·5 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205,...
Drugs·45 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA...
Injectable Drugs·3 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA ...
Injectable Drugs·24 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509...
Injectable Drugs·10 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (...
Injectable Drugs·5 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c) 12 EA, Rx only, First Pharma Associates dba Riverpoint Ph...
Ophthalmic Drugs·60 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 mL. b) 9.6 mL, c) 10.8mL vial, Rx only, First Pharma Associat...
Injectable Drugs·14 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (5...
Injectable Drugs·8 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Injectable Drugs·8 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane...
Injectable Drugs·50 affected·Jun 26, 2019
High RiskFDA
First Pharma Associates Llc Dba Riverpoint Pharmacy
Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 992...
Injectable Drugs·60 affected·Jun 26, 2019
High RiskFDA
Biopro, Inc.
Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is int...
Surgical Devices·2 affected·Jun 25, 2019
High RiskFDA
Biopro, Inc.
K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS Sys...
Surgical Devices·240 affected·Jun 25, 2019