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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 781–786 of 786 recalls

Class IIITerminated

Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Spinal Elements, Inc

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

April 17, 2009 · DeviceView details →

Class IIITerminated

Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Spinal Elements, Inc

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

April 17, 2009 · DeviceView details →

Class IIITerminated

Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

Spinal Elements, Inc

Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

April 17, 2009 · DeviceView details →

Class IIITerminated

Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.

Sunquest Information Systems, Inc.

Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.

April 13, 2009 · DeviceView details →

Class IIITerminated

Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

Orthosoft, Inc. dba Zimmer CAS

ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.

June 20, 2008 · DeviceView details →

Class IIITerminated

Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.

Radiometer America Inc

The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.

June 6, 2006 · DeviceView details →

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