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
Windstone Medical Packaging, Inc.
Hall SAP, Kit number SRK1031(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·30 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating room
Medical Devices·32 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Dr. Casey Pack, kit number AMS4313 convenience custom kits used for general surgery in hospital operating room
Medical Devices·48 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room
Medical Devices·5,388 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
Medical Devices·288 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·1,599 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·214 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·1,144 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in hospital operating room
Medical Devices·20 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in hospital operating room
Medical Devices·156 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on t...
Surgical Devices·24 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custom kits used for general surgery in hospital operating room
Medical Devices·1,160 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on t...
Surgical Devices·448 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Cath Pack, kit number AMS4283 convenience custom kits used for general surgery in hospital operating room
Medical Devices·246 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsibl...
Surgical Devices·36 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·510 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital ...
Medical Devices·1,470 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital operating room
Medical Devices·280 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Morris Lap Pack, Kit number PSS3199 and PSS3199(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·80 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Basin Pack, kit number AMS2497 convenience custom kits used for general surgery in hospital operating room
Medical Devices·1,243 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. con...
Medical Devices·505 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing cover light handle soft, RX. The responsible firm on the la...
Surgical Devices·24 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·56 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible fi...
Cardiac Devices·54 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room
Medical Devices·312 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
Medical Devices·30 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room
Medical Devices·53 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible fir...
Cardiac Devices·24 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit containing cover light handle soft, RX. The responsible firm on th...
Surgical Devices·200 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·117 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·290 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Custom Arterial Pack, kit number RMS1712(F convenience custom kits used for general surgery in hospital operating room
Medical Devices·102 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
General Pack II, Kit number CMP1812(B convenience custom kits used for general surgery in hospital operating room
Medical Devices·135 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on...
Surgical Devices·114 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Bleph Pack, Kit part number AMS3325 convenience custom kits used for general surgery in hospital operating room
Medical Devices·10 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
Cardiac Devices·102 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·1,795 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·184 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
Medical Devices·1,200 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Dr. Harrimans Kit, Kit number PSS3600 convenience custom kits used for general surgery in hospital operating room
Medical Devices·120 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·125 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on th...
Surgical Devices·48 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing light handle soft, RX. The responsible firm on the label i...
Surgical Devices·100 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
Medical Devices·600 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room
Medical Devices·70 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm...
Surgical Devices·222 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room
Medical Devices·765 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
Medical Devices·852 affected·Apr 22, 2015