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All Product Recalls
78,569 recalls
High RiskFDA
Windstone Medical Packaging, Inc.
Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in hospital operating room
Medical Devices20 affectedApr 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 Devices156 affectedApr 22, 2015
High RiskFDA
Vilex In Tennessee Inc
Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Medical Devices7 affectedApr 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 Devices24 affectedApr 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 Devices1,160 affectedApr 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 Devices448 affectedApr 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 Devices246 affectedApr 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 Devices36 affectedApr 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 Devices510 affectedApr 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 Devices1,470 affectedApr 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 Devices280 affectedApr 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 Devices80 affectedApr 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 Devices1,243 affectedApr 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 Devices505 affectedApr 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 Devices24 affectedApr 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 Devices56 affectedApr 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 Devices54 affectedApr 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 Devices312 affectedApr 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 Devices30 affectedApr 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 Devices53 affectedApr 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 Devices24 affectedApr 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 Devices200 affectedApr 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 Devices117 affectedApr 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 Devices290 affectedApr 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 Devices102 affectedApr 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 Devices135 affectedApr 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 Devices114 affectedApr 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 Devices10 affectedApr 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 Devices102 affectedApr 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 Devices1,795 affectedApr 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 Devices184 affectedApr 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 Devices1,200 affectedApr 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 Devices120 affectedApr 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 Devices125 affectedApr 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 Devices48 affectedApr 22, 2015
High RiskFDA
Roche Diabetes Care, Inc.
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Diabetes Devices35,795 affectedApr 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 Devices100 affectedApr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
Medical Devices600 affectedApr 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 Devices70 affectedApr 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 Devices222 affectedApr 22, 2015
High RiskFDA
Roche Diabetes Care, Inc.
AccuChek Spirit insulin infusion pump.
Diabetes Devices35,795 affectedApr 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 Devices765 affectedApr 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 Devices852 affectedApr 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 Devices360 affectedApr 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 Devices2,048 affectedApr 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 Devices224 affectedApr 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 Devices48 affectedApr 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 Devices40 affectedApr 22, 2015