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.
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
High RiskFDA
Windstone Medical Packaging, Inc.
Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operat...
Medical Devices·2,266 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·648 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible fir...
Surgical Devices·500 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible ...
Cardiac Devices·57 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible ...
Surgical Devices·136 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general surgery in hospital operating room
Medical Devices·802 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom k...
Medical Devices·3,104 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·158 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room
Medical Devices·58 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm o...
Cardiac Devices·40 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room
Medical Devices·288 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the...
Surgical Devices·7,904 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
Medical Devices·268 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Port Access Kit, Kit number PSS1505(C convenience custom kits used for general surgery in hospital operating room
Medical Devices·227 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating room
Medical Devices·160 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room
Medical Devices·123 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on th...
Surgical Devices·164 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospita...
Medical Devices·0 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
OB/GYN Pack, Kit number AMS2038 convenience custom kits used for general surgery in hospital operating room
Medical Devices·18 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·630 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
Medical Devices·115 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for ge...
Medical Devices·1,528 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS23...
Medical Devices·8,132 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
GYN Lap Pack, Kit number PSS2194(B convenience custom kits used for general surgery in hospital operating room
Medical Devices·20 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on t...
Surgical Devices·26 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 convenience custom kits used for general surgery in hospital operating room
Medical Devices·56 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·186 affected·Apr 22, 2015
High RiskFDA
Resource Optimization & Innovation Llc
regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit containing cover light handle soft, RX. The responsible firm o...
Surgical Devices·1,233 affected·Apr 22, 2015