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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 61–80 of 39,430 recalls

Class IIOngoing

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-Line, White Model/Catalog Number: ASP-564010 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 12) GRAY Model/Catalog Number: A70107005 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog Number: DT-7112-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.

Olympus Corporation of the Americas

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7020-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 10) GREEN Model/Catalog Number: 564015 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE (10) Model/Catalog Number: DT-7034-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 1 LINE (10) Model/Catalog Number: DB-7018-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 10) GREEN Model/Catalog Number: 564014 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE (10) Model/Catalog Number: DT-7024-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IOngoing

Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041 IMAGER II/5/BARNH/100/038 BX5; M001314051 IMAGER II/5/BERN/100/038 BX5; M001314061 IMAGER II/5/BERN/100/035 BX 5; M001314081 IMAGER II/5/BERN/40/038 BX5; M001314101 IMAGER II/5/BERN/65/038 BX5; M001314141 IMAGER II/5/H1/100/038 BX5; M001314151 IMAGER II/5/H1/100/035 BX 5; M001314301 IMAGER II/5/SIM1/65/038 BX5; M001314321 IMAGER II/5/SIM1/100/038 BX5; M001314341 IMAGER II/5/SIM2/100/038 BX5; M001314351 IMAGER II/5/SIM2/100/035 BX 5; M001314361 IMAGER II/5/SIM3/100/038 BX5; M001314521 IMAGER II/5/CHGB/65/038 BX5; M001314581 IMAGER II/5/CONTRA 2/65/038 BX5; M001314621 IMAGER II/5/C1/65/038 BX5; M001314661 00AGER II/5/C2/65/038 BX5; M001314671 IMAGER II/5/C2/65/035 BX 5; M001314761 IMAGER II/5/MIK/65/038 BX5; M001314771 IMAGER II/5/MIK/65/035 BX 5; M001314821 IMAGER II/5/SHK1.0/65/038 BX5; M001314861 IMAGER II/5/RC2/65/038 BX5; M001314881 IMAGER II/5/RDC/65/038 BX5

Boston Scientific Corporation

Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 10) BLUE Model/Catalog Number: 564013 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 10) GRAY Model/Catalog Number: 564005 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 1-LINE (CS 12) GRAY Model/Catalog Number: A70107004 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM Model/Catalog Number: 564003 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 1-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107000 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red Model/Catalog Number: ASP-564006 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White Model/Catalog Number: ASP-564011 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
Class IIOngoing

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog Number: DT-7044-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

ASP Global, LLC.

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

August 24, 2026 · DeviceView details →
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