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.
Head/Neck Pack, part number AMS6121
Medical Devices·24 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere...
Medical Devices·875 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C
Medical Devices·156 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part num...
Medical Devices·810 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Reduction Mammoplasty Pack, part number AMS4380 Reduction Mammoplasty Pack, part number AMS4380(B
Medical Devices·35 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Augmentation Pack, part number AMS6370
Medical Devices·60 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
General Plastics Pack, part number 008617-1
Medical Devices·465 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Liposuction Pack, part number AMS3323(B Liposuction Pack, part number AMS5684 Liposuction Pack, part number AMS5699
Medical Devices·35 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Total Knee Pack (15710), part number AMS6563
Medical Devices·60 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
GYN Pack, part number AMS4013(A
Medical Devices·20 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Lap Pack, part number AMS4801
Medical Devices·36 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Ocular Plastic Pack, part number AMS3868(A
Medical Devices·100 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Opgrande Hand Pack, part number AMS4767
Medical Devices·48 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Hysteroscopy Pack, part number AMS4797 Hysteroscopy Pack, part number AMS4797(A Hysteroscopy Pack, part number AMS4797(B
Medical Devices·130 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Extremity Pack (1344), part number AMS6561
Medical Devices·60 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Chest Breast Drape, part number AMS5853
Medical Devices·60 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472
Medical Devices·286 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part numbe...
Medical Devices·606 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
Medical Devices·276 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Basin Pack, part number AMS2497
Medical Devices·648 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A
Medical Devices·1,787 affected·Jan 11, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Hystero Pack, part number PSS3535(A
Medical Devices·32 affected·Jan 11, 2017
High RiskFDA
Encore Medical, Lp
LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem...
Medical Implants·13 affected·Jan 10, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills
Medical Devices·15 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn
Medical Devices·208 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa
Medical Devices·100 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn
Cardiac Devices·274 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo
Medical Devices·206 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU
Medical Devices·1,548 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa
Medical Devices·209 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Santa Rosa
Medical Devices·150 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Santa Rosa
Medical Devices·384 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU
Cardiac Devices·26 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa
Medical Devices·210 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills
Medical Devices·460 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn
Medical Devices·164 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
Medical Devices·212 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn
Medical Devices·112 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels
Medical Devices·46 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
Cardiac Devices·28 affected·Jan 9, 2017
High RiskFDA
Advanced Sterilization Products
STERRAD NX Sterilization System, Product Code: 10033, 10033-002
Medical Devices·7,694 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills
Medical Devices·834 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels
Medical Devices·88 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn
Medical Devices·92 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
Medical Devices·30 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
Medical Devices·356 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn
Medical Devices·208 affected·Jan 9, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
Medical Devices·32 affected·Jan 9, 2017