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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 641–660 of 1,000 recalls

Class IITerminated

These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020

Hill-Rom Inc.

An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.

October 14, 2021 · DeviceView details →
Class ITerminated

IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical

Lumenis, Inc.

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

October 14, 2021 · Device
View details →
Class IITerminated

Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000

Siemens Medical Solutions USA, Inc

Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

October 12, 2021 · DeviceView details →
Class IITerminated

Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600

Siemens Medical Solutions USA, Inc

Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

October 12, 2021 · DeviceView details →
Class IITerminated

Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700

Siemens Medical Solutions USA, Inc

Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

October 12, 2021 · DeviceView details →
Class IITerminated

Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440

Clark Laboratories, Inc.

Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay

October 11, 2021 · DeviceView details →
Class IITerminated

GM Helix Acqua Implant 3.5x10, Article No. 140.944

Jjgc Industria E Comercio De Materials Dentarios Sa

3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.

October 11, 2021 · DeviceView details →
Class IITerminated

BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic medium in glass vials 442022/BD BACTEC Plus Anaerobic medium in plastic vials 442020/BD BACTEC Peds Plus mediums in plastic vials All lots with an expiry date prior to

BioFire Diagnostics, LLC

Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the blood culture vials.

October 11, 2021 · DeviceView details →
Class IITerminated

VirtuTRAX Instrument Navigator, 14 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 with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

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 14 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

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 →
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