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All Product Recalls

49,209 recalls (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
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
Roche Diabetes Care, Inc.
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Diabetes Devices·35,795 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
Roche Diabetes Care, Inc.
AccuChek Spirit insulin infusion pump.
Diabetes Devices·35,795 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
High RiskFDA
Windstone Medical Packaging, Inc.
Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for general surgery in hospital oper...
Medical Devices·360 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operat...
Medical Devices·2,048 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in hospital operating room
Medical Devices·224 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
GYN Pack, Kit number PSS2643 convenience custom kits used for general surgery in hospital operating room
Medical Devices·48 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Lipo Pack, Kit number AMS4420 convenience custom kits used for general surgery in hospital operating room
Medical Devices·40 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
GLBSC Minor Pack, Kit number PSS2644 convenience custom kits used for general surgery in hospital operating room
Medical Devices·60 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room
Medical Devices·249 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on t...
Surgical Devices·726 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·68 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible fir...
Surgical Devices·62 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible ...
Cardiac Devices·37 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
Medical Devices·816 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room
Medical Devices·2,225 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Major Pack, Kit Number PSS3516 and PSS3516(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·64 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·720 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm...
Cardiac Devices·199 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room
Medical Devices·545 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible ...
Surgical Devices·158 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
Medical Devices·352 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room
Medical Devices·15 affected·Apr 22, 2015