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
Brassica Pharma Pvt Ltd
Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Ben...
Topical Drugs·355,633 affected·Jan 30, 2024
High RiskFDA
Applied Medical Resources Corp
Epix Universal Clip Applier, REF: CA500, STERILEEO
Medical Devices·0 affected·Jan 30, 2024
High RiskFDA
Applied Medical Resources Corp
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, K...
Medical Devices·17,990 affected·Jan 30, 2024
High RiskFDA
Synthes (usa) Products Llc
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Medical Devices·30 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacia...
Medical Devices·10 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe f...
Medical Devices·5 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number:...
Medical Devices·11 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Surgical Devices·17 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
Medical Devices·47 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
Surgical Devices·30 affected·Jan 24, 2024
High RiskFDA
Integradose Compounding Services Llc
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kaso...
Injectable Drugs·1,299 affected·Jan 22, 2024
CriticalFDA
Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebros...
Medical Devices·30,711 affected·Jan 22, 2024
CriticalFDA
Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebro...
Medical Devices·32,404 affected·Jan 22, 2024
CriticalFDA
Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used ...
Surgical Devices·3 affected·Jan 22, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ...
Medical Devices·1,324 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·27 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·161 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·30 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Medical Devices·188 affected·Jan 19, 2024
High RiskFDA
Integra Lifesciences Corp.
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the br...
Medical Devices·4 affected·Jan 19, 2024
High RiskFDA
Convatec, Inc
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Surgical Devices·1,715 affected·Jan 17, 2024
High RiskFDA
Maquet Medical Systems Usa
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Cardiac Devices·16,520 affected·Jan 16, 2024
High RiskFDA
Maquet Medical Systems Usa
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Cardiac Devices·16,520 affected·Jan 16, 2024
CriticalFDA
Avanos Medical, Inc.
MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/...
Surgical Devices·10,808 affected·Jan 16, 2024
CriticalFDA
Avanos Medical, Inc.
MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radio...
Surgical Devices·53,126 affected·Jan 16, 2024
High RiskFDA
Medical Action Industries, Inc. 306
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Medical Devices·206,200 affected·Jan 15, 2024
High RiskFDA
Be Pharmaceuticals Ag
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Singl...
Injectable Drugs·22,176 affected·Jan 10, 2024
High RiskFDA
Aesculap Inc
DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
Medical Devices·18 affected·Jan 9, 2024
High RiskFDA
Aesculap Inc
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
Medical Devices·6 affected·Jan 9, 2024
High RiskFDA
Aesculap Inc
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
Medical Devices·6 affected·Jan 9, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Medical Devices·4,831 affected·Jan 4, 2024
High RiskFDA
Tornier, Inc
Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Medical Devices·50 affected·Jan 3, 2024
High RiskFDA
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Walt...
Drugs·69,590 affected·Dec 28, 2023
CriticalFDA
Cardinal Health 200, Llc
Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
Medical Devices·0 affected·Dec 28, 2023
CriticalFDA
Cardinal Health 200, Llc
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
Medical Devices·0 affected·Dec 28, 2023
CriticalFDA
Cardinal Health 200, Llc
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
Medical Devices·0 affected·Dec 28, 2023
CriticalFDA
Cardinal Health 200, Llc
Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
Medical Devices·0 affected·Dec 28, 2023
CriticalFDA
Cardinal Health 200, Llc
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
Medical Devices·0 affected·Dec 28, 2023
CriticalFDA
Windstone Medical Packaging, Inc.
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Medical Devices·80 affected·Dec 22, 2023
CriticalFDA
Windstone Medical Packaging, Inc.
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Medical Devices·128 affected·Dec 22, 2023
CriticalFDA
Windstone Medical Packaging, Inc.
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Medical Devices·475 affected·Dec 22, 2023
High RiskFDA
Covidien Lp
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON...
Medical Devices·46,812 affected·Dec 21, 2023
High RiskFDA
Paragon 28, Inc.
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Medical Devices·1 affected·Dec 21, 2023
High RiskFDA
Origen Biomedical, Inc.
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with ...
Medical Devices·3,613 affected·Dec 19, 2023
High RiskFDA
St. Jude Medical, Atrial Fibrillation Division, Inc.
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Surgical Devices·483 affected·Dec 18, 2023
High RiskFDA
Olympus Corporation Of The Americas
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Respiratory Devices·600 affected·Dec 11, 2023
High RiskFDA
Globus Medical, Inc.
Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. ...
Medical Devices·0 affected·Dec 11, 2023
High RiskFDA
Globus Medical, Inc.
Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the Excelsius...
Medical Devices·0 affected·Dec 11, 2023