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
Covidien Llc
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Medical Devices·1,661 affected·Apr 28, 2015
High RiskFDA
Sheffield Pharmaceuticals, Llc
Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
Medical Devices·37,636 affected·Apr 27, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room
Medical Devices·615 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom ki...
Medical Devices·1,124 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room
Cardiac Devices·138 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·48 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·145 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room
Medical Devices·356 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·86 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·230 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room
Medical Devices·85 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
Medical Devices·130 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·1,476 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·16 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible fi...
Surgical Devices·1,400 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·175 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible fir...
Surgical Devices·124 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible...
Cardiac Devices·36 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room
Medical Devices·15 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in h...
Medical Devices·5,723 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operati...
Medical Devices·838 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
Medical Devices·230 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The respo...
Surgical Devices·324 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on ...
Surgical Devices·72 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
Medical Devices·1,780 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital...
Medical Devices·2,004 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible f...
Cardiac Devices·440 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Student Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in hospital operating room
Medical Devices·5 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospit...
Medical Devices·192 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom kits used for general surgery in hospital operating room
Medical Devices·132 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible fir...
Surgical Devices·746 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·92 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
Medical Devices·140 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit containing cover light handle soft, RX. The responsible firm on ...
Surgical Devices·200 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on t...
Surgical Devices·144 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room
Medical Devices·20 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room
Medical Devices·33 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible...
Surgical Devices·64 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm ...
Surgical Devices·3,099 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, P...
Medical Devices·6,526 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible f...
Surgical Devices·658 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room
Medical Devices·27 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room
Medical Devices·28 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·120 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room
Medical Devices·99 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits ...
Medical Devices·3,829 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital operating room
Medical Devices·85 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on th...
Surgical Devices·904 affected·Apr 22, 2015