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 4861–4880 of 39,430 recalls

Class IICompleted

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.

Caire, Inc.

Potential failure of affected units to recharge the battery of the oxygen concentrators.

October 4, 2024 · DeviceView details →

Class IIOngoing

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720

Hobbs Medical, Inc.

Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.

October 4, 2024 · DeviceView details →

microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.

A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244517 of P/N 66-IT-06P. Use of the product with a spacer tube which is too long could result in intercranial hemorrhaging and brain damage.

FDA Device Recalls

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720

microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.

Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0

DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06

DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0

DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2

Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

DeRoyal C-SECTION TRACEPACK, REF 89-9338-06

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001B2

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F2

Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.