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
Centurion Medical Products Corporation
Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C C...
Medical Implants·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM
Medical Devices·1,820 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion IVS3505 ULTRASOUND GUIDED PIV KIT
Medical Devices·350 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRA...
Surgical Devices·1,986 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PIC...
Medical Devices·0 affected·Dec 11, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION...
Surgical Devices·0 affected·Dec 11, 2019
Medium RiskFDA
Auromedics Pharma Llc
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Phar...
Topical Drugs·100,080 affected·Dec 2, 2019
High RiskFDA
Degania Silicone, Ltd.
Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary outp...
Surgical Devices·2,080 affected·Dec 2, 2019
High RiskFDA
Medela Inc
Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a...
Medical Devices·331 affected·Dec 2, 2019
High RiskFDA
Microvention, Inc.
Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-7505...
Medical Devices·1,187 affected·Nov 24, 2019
High RiskFDA
Microvention, Inc.
Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx....
Medical Devices·107 affected·Nov 24, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-...
Medical Devices·2,762 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, ...
Medical Devices·19 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V...
Medical Devices·85 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204H...
Medical Devices·169 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 18093...
Medical Devices·32 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 10010...
Medical Devices·5,777 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206H...
Medical Devices·780 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, ...
Medical Devices·409 affected·Nov 22, 2019
High RiskFDA
Zest Anchors Llc
LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .
Medical Implants·154 affected·Nov 22, 2019
High RiskFDA
Microvention, Inc.
MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315V...
Medical Devices·666 affected·Nov 22, 2019
High RiskFDA
Pacira Pharmaceuticals, Inc.
EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira...
Injectable Drugs·910 affected·Nov 21, 2019
High RiskFDA
Datascope Corporation
Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET I...
Surgical Devices·523 affected·Nov 20, 2019
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Drugs·22,336 affected·Nov 19, 2019
RecallFDA
Livanova Usa Inc.
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Medical Devices·140 affected·Nov 18, 2019
RecallFDA
Rising Pharmaceuticals, Inc.
Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharma...
Topical Drugs·0 affected·Nov 15, 2019
RecallFDA
Rising Pharmaceuticals, Inc.
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc...
Topical Drugs·15,072 affected·Nov 15, 2019
CriticalFDA
Tytek Medical Inc
PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the remov...
Medical Devices·3,565 affected·Nov 15, 2019
High RiskFDA
Getinge Us Sales Llc
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Respiratory Devices·3,633 affected·Nov 13, 2019
High RiskFDA
Medtronic Xomed, Inc.
Lamicel 10PK 10MM INTL
Medical Devices·10 affected·Nov 13, 2019
High RiskFDA
Trilliant Surgical, Llc
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
Medical Devices·117 affected·Nov 4, 2019
High RiskFDA
Allergan Plc
XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Au...
Medical Implants·145,711 affected·Oct 30, 2019
CriticalFDA
Applied Medical Resources Corp
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)0060791511...
Surgical Devices·28,799 affected·Oct 24, 2019
High RiskFDA
Centurion Medical Products Corporation
Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
Medical Devices·80 affected·Oct 24, 2019
High RiskFDA
Boston Scientific Corporation
NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7...
Surgical Devices·14,145 affected·Oct 24, 2019
High RiskFDA
Boston Scientific Corporation
Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H749393351...
Surgical Devices·14,145 affected·Oct 24, 2019
High RiskFDA
Edwards Lifesciences, Llc
EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 0069...
Medical Devices·62,431 affected·Oct 22, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·30 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·10 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·5 affected·Oct 21, 2019
High RiskFDA
Integra Lifesciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Medical Devices·820 affected·Oct 21, 2019
High RiskFDA
Integra Lifesciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Medical Devices·820 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·10 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·30 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·5 affected·Oct 21, 2019
High RiskFDA
Integra Lifesciences Corp.
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Medical Devices·0 affected·Oct 21, 2019
High RiskFDA
Cook Inc.
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid art...
Surgical Devices·425 affected·Oct 21, 2019