BEUDAMED
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    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew Inc.·March 5, 2014

    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

    FDA Recall
    Terminated ·Smith & Nephew Inc.·Product code OMP·November 14, 2013

    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

    FDA Recall
    Terminated ·Accelerate Diagnostics Inc·Product code PRH·March 14, 2018

    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

    FDA Enforcement
    Class II ·Terminated·Accelerate Diagnostics Inc·May 2, 2018

    Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA. Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9. Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8. Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6. The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DRE·November 3, 2011

    MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

    FDA Recall
    Terminated ·Product code LXC·June 28, 2021

    The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code OCC·October 10, 2013

    SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

    FDA Recall
    Terminated ·Akita Sumitomo Bakelite Co., Ltd. 27-4, Aza Nakajimita Akita Japan·Product code KNS·September 9, 2016

    SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

    FDA Recall
    Terminated ·Akita Sumitomo Bakelite Co., Ltd. 27-4, Aza Nakajimita Akita Japan·Product code KNS·September 9, 2016

    Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010

    American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    THREAD RETRIEVAL DRILL REF 2224

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZA·July 10, 2017

    American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016

    American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges

    FDA Recall
    Terminated ·American Surgical Company·Product code HBA·March 31, 2016