American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula.
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.
Class I - Dangerous
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 becomes non-sterile and is used or implanted, it may lead to an infection.
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Roche Molecular Systems
Class I - Dangerous
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 Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).
American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility