FDA Recalls USDA Recalls About

FDA Recalls

Food recalls
Drug recalls
Device recalls

USDA Recalls

All USDA recalls
Poultry recalls
Meat recalls
Egg recalls

About

About us
FDA guides
USDA guides
Data sources
Privacy policy

Data

OpenFDA API
USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

FDA Recalls
›Device Recalls

FDA Device Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 481–500 of 1,000 recalls

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 II

Ongoing

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 →

Class IIOngoing

Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws). The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The Veritas standard glenoid baseplate is the only component within scope of this field action. The patient-specific baseplate is unaffected by this defect and therefore not in scope. Component: Reverse Total Shoulder

restor3d Inc.

Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

June 30, 2026 · DeviceView details →

Class IIOngoing

Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.

Boston Scientific Corporation

Potential for breach in sterile barrier of device packaging.

June 30, 2026 · DeviceView details →

Class IIOngoing

Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN

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 →

Class IIOngoing

Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN

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 →

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

Baxter Healthcare Corporation

Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.

June 30, 2026 · DeviceView details →

Class IIOngoing

Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.

Fresenius Medical Care Renal Therapies Group, LLC

Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.

June 30, 2026 · DeviceView details →

Class IIOngoing

Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240cm Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.

Boston Scientific Corporation

Potential for breach in sterile barrier of device packaging.

June 30, 2026 · DeviceView details →

Class IIOngoing

Merge PACS, medical imaging diagnostic workstation

Merge Healthcare, Inc.

Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

June 30, 2026 · DeviceView details →

Class IIOngoing

Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN

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 →

Class IIOngoing

SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.

KENT IMAGING, INC.

The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.

June 30, 2026 · DeviceView details →

← PreviousPage 25 of 50Next →