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
American Surgical Company
American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·37 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·165 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·155 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·99 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·2 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·27 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·3 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·266 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·37 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·237 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·4 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·78 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·70 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·165 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·11 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·54 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·35 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·33 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·409 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·3 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·45 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·10 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·3 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·1 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·338 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·2 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·10 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·27 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·25 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·38 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·87 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·178 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·4 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·689 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·16 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·28 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·24 affected·Mar 31, 2016
High RiskFDA
American Surgical Company
American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Surgical Devices·3 affected·Mar 31, 2016
High RiskFDA
Teleflex Medical
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. Product Usage: Pleur-Evac...
Medical Devices·12,124 affected·Mar 30, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H74914...
Medical Devices·47 affected·Mar 28, 2016
CriticalFDA
Monteris Medical Corp
NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322...
Medical Devices·121 affected·Mar 25, 2016
High RiskFDA
Remel Inc
Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity ...
Diagnostic Devices·2 affected·Mar 24, 2016
High RiskFDA
Teleflex Medical
Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture lo...
Medical Devices·45 affected·Mar 24, 2016
High RiskFDA
Stryker Neurovascular
GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intend...
Surgical Devices·316 affected·Mar 21, 2016
High RiskFDA
Windstone Medical Packaging, Inc.
Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. There are multip...
Surgical Devices·40 affected·Mar 21, 2016
High RiskFDA
Stryker Neurovascular
GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended...
Surgical Devices·316 affected·Mar 21, 2016
High RiskFDA
Windstone Medical Packaging, Inc.
General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple com...
Surgical Devices·170 affected·Mar 21, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are...
Medical Devices·339 affected·Mar 21, 2016