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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 601–620 of 1,000 recalls

Class IITerminated

VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

Civco Medical Instruments Co. Inc.

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

October 8, 2021 · DeviceView details →
Class IITerminated

Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

Cook Inc.

Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.

October 8, 2021 · DeviceView details →
Class IITerminated

VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX

Civco Medical Instruments Co. Inc.

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

October 8, 2021 · DeviceView details →
Class IITerminated

BioGlue Surgical Adhesive, Model BG3510-5-G

CryoLife, Inc.

Product is not approved for use in the EU and should not have been distributed in the EU.

October 7, 2021 · DeviceView details →
Class IITerminated

3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.

3M Company - Health Care Business

Potential for breakage of the ECG electrode carbon stud from the eyelet.

October 6, 2021 · DeviceView details →
Class IIITerminated

A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis

Primus Corporation dba Trinity Biotech

The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.

October 5, 2021 · DeviceView details →
Class IIITerminated

Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis

Primus Corporation dba Trinity Biotech

The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.

October 5, 2021 · DeviceView details →
Class IITerminated

Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288

AB SCIEX

The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may lead to the user making incorrect conclusions using incorrect results.

October 4, 2021 · DeviceView details →
Class IITerminated

REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852

Limacorporate S.p.A

There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.

October 1, 2021 · DeviceView details →
Class IITerminated

OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.

OmniLife Science

The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.

October 1, 2021 · DeviceView details →
Class IITerminated

REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

Limacorporate S.p.A

There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.

October 1, 2021 · DeviceView details →
Class IITerminated

API 50 CH, Model 50300

bioMerieux, Inc.

There is potential to provide an incorrect organism identification.

September 30, 2021 · DeviceView details →
Class IITerminated

Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

Covidien Llc

The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.

September 29, 2021 · DeviceView details →
Class IITerminated

Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.

Cook Inc.

Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.

September 28, 2021 · DeviceView details →
Class IITerminated

Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.

ELEKTA SOLUTIONS AB

There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.

September 28, 2021 · DeviceView details →
Class IITerminated

Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.

Cook Inc.

Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.

September 28, 2021 · DeviceView details →
Class IITerminated

BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822

Becton Dickinson & Company

Holes in product packaging impacts package integrity and may compromise sterility.

September 27, 2021 · DeviceView details →
Class IITerminated

Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

Philips North America Llc

When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop reacting on movement requests (table lock-up) and X-ray imaging becomes unavailable.

September 24, 2021 · DeviceView details →
Class IITerminated

ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866

Siemens Healthcare Diagnostics, Inc

Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.

September 22, 2021 · DeviceView details →
Class IITerminated

Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861

Siemens Healthcare Diagnostics, Inc

Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.

September 22, 2021 · DeviceView details →
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