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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 421–440 of 1,000 recalls

Class IIOngoing

Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);

DRG International, Inc.

Potential for false negative patient results.

July 2, 2026 · DeviceView details →
Class IIOngoing

Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.

Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

July 1, 2026 · DeviceView details →
Class II
Ongoing

5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905

Aniara Diagnostica LLC

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.

July 1, 2026 · DeviceView details →
Class IIOngoing

Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.

Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

July 1, 2026 · DeviceView details →
Class IIOngoing

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm

Biomet, Inc.

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

July 1, 2026 · DeviceView details →
Class IIOngoing

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm

Biomet, Inc.

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

July 1, 2026 · DeviceView details →
Class IIOngoing

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm

Biomet, Inc.

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

July 1, 2026 · DeviceView details →
Class IIOngoing

Cardiac Workstation 5000. Product Number: 860439.

Philips North America Llc

Device will intermittently provide inaccurate data related to native heart rate.

July 1, 2026 · DeviceView details →
Class IIOngoing

Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.

Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

July 1, 2026 · DeviceView details →
Class IIOngoing

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm

Biomet, Inc.

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

July 1, 2026 · DeviceView details →
Class IIOngoing

Cardiac Workstation 7000. Product Number: 860441.

Philips North America Llc

Device will intermittently provide inaccurate data related to native heart rate.

July 1, 2026 · DeviceView details →
Class IIOngoing

Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.

Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

July 1, 2026 · DeviceView details →
Class IIOngoing

Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.

Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

July 1, 2026 · DeviceView details →
Class IIOngoing

Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.

Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

July 1, 2026 · DeviceView details →
Class IIOngoing

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm

Biomet, Inc.

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

July 1, 2026 · DeviceView details →
Class IIOngoing

5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905

Aniara Diagnostica LLC

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.

July 1, 2026 · DeviceView details →
Class IIOngoing

5-PLASMA Bivalirudin Control, Model Number 5D-44905

Aniara Diagnostica LLC

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.

July 1, 2026 · DeviceView details →
Class IIOngoing

Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.

Stryker GmbH

Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

July 1, 2026 · DeviceView details →
Class IIOngoing

Rapid Refill Continuous Injection System, UPN M00566001

Boston Scientific Corporation

Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.

June 30, 2026 · DeviceView details →
Class IIOngoing

Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4

Medline Industries, LP

Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.

June 30, 2026 · DeviceView details →
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