Medical DeviceJun 1, 2016
American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical recall — FDA Z-1756-2016
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 1074
28,992 detailed records are currently available in this category.
Medical DeviceJun 1, 2016
American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and recall — FDA Z-1767-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage recall — FDA Z-1799-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical recall — FDA Z-1723-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
Angiodynamics Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use recall — FDA Z-1701-2016
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-1820-2016
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
Roche Molecular Systems cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation recall — FDA Z-1830-2016
An error was found within the Hungarian translations of the cobas EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas cfDNA Sample…
Class IIFDA: TerminatedRoche Molecular Systems, Inc.
Medical DeviceJun 1, 2016
American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage recall — FDA Z-1734-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage recall — FDA Z-1751-2016
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-1817-2016
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 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and recall — FDA Z-1787-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and recall — FDA Z-1807-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product Usage recall — FDA Z-1745-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and recall — FDA Z-1805-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical recall — FDA Z-1761-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical and recall — FDA Z-1742-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
B. Braun Medical WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in) recall — FDA Z-1703-2016
Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceJun 1, 2016
American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and recall — FDA Z-1790-2016
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-1828-2016
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 Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and recall — FDA Z-1810-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Usage recall — FDA Z-1760-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage recall — FDA Z-1777-2016
Product packaging defective compromising sterility
Class IIFDA: TerminatedAmerican Surgical Company
Medical DeviceJun 1, 2016
American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical recall — FDA Z-1758-2016
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-1825-2016
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.