Medical DeviceJun 1, 2016
American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product Usage recall — FDA Z-1788-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
28,992medical device recall records
2,381FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1076
28,992 detailed records are currently available in this category.
Medical DeviceJun 1, 2016
RTI Surgical Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque recall — FDA Z-1829-2016
Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip,…
Class IIFDA: TerminatedRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceJun 1, 2016
American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and recall — FDA Z-1801-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and recall — FDA Z-1721-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical and recall — FDA Z-1786-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
RAYSEARCH LABORATORIES AB RayStation Therapy Treatment Planning System Stand-alone Software recall — FDA Z-1712-2016
A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsynchronized…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJun 1, 2016
American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and recall — FDA Z-1746-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and recall — FDA Z-1792-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical recall — FDA Z-1759-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
Biomet Various trauma and sports medicine instruments and implants recall — FDA Z-1822-2016
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product…
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceJun 1, 2016
American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and recall — FDA Z-1789-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product Usage recall — FDA Z-1741-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
Angiodynamics AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870 recall — FDA Z-1702-2016
Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics…
Class IIFDA: TerminatedAngiodynamics Inc. (Navilyst Medical Inc.)
Medical DeviceJun 1, 2016
Biomet Various trauma and sports medicine instruments and implants recall — FDA Z-1824-2016
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product…
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceJun 1, 2016
American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Usage recall — FDA Z-1762-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical recall — FDA Z-1754-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: Neurosurgical and recall — FDA Z-1740-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: Neurosurgical recall — FDA Z-1731-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage: Neurosurgical recall — FDA Z-1727-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical recall — FDA Z-1725-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and recall — FDA Z-1770-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and recall — FDA Z-1784-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage recall — FDA Z-1749-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
Biomet Various trauma and sports medicine instruments and implants recall — FDA Z-1821-2016
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product…
Class IIFDA: TerminatedBiomet, Inc.
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.