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 601–620 of 1,000 recalls

Class ITerminated

Puritan Bennett 980 Series Ventilator, 980U3ESDIUU

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →

Class ITerminated

Puritan Bennett 980 Series Ventilator, 980X3JADIJJ

Covidien Llc

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

November 4, 2021 · DeviceView details →

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

FDA Device Recalls

Puritan Bennett 980 Series Ventilator, 980U3ESDIUU

Puritan Bennett 980 Series Ventilator, 980X3JADIJJ

Puritan Bennett 980 Series Ventilator, 980X1PLDIPC

INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS

Leica Microsystems M220 F12 Microscope Systems

Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1

smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202

smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201

Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

EVLP Convenience Pack/Kit

Venous Access Pack-LF Convenience Kit

Major Vascular CDS Convenience Kit

Bedside PICC CDS Convenience Kit

Neuro Convenience Kit

MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441