🔍 RecallPedia
🏥

Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.

Medtronic Sofamor Danek USA

Class I - Dangerous

The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.

Mar 13, 2018 Implants & Prosthetics Nationwide View Details →

Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge

Siemens Healthcare Diagnostics

Class I - Dangerous

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

Jan 2, 2018 Other Medical Devices Nationwide View Details →

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Vyaire Medical

Class I - Dangerous

The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.

Apr 27, 2017 Infusion Pumps Nationwide View Details →

Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).

Draeger Medical

Class I - Dangerous

The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.

Mar 1, 2018 Diagnostic Equipment Nationwide View Details →

AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Vyaire Medical

Class I - Dangerous

The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.

Apr 27, 2017 Infusion Pumps Nationwide View Details →

IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid

Siemens Healthcare Diagnostics

Class I - Dangerous

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Jan 2, 2018 Other Medical Devices Nationwide View Details →

ADVIA Centaur¿ Cyclosporine

Siemens Healthcare Diagnostics

Class I - Dangerous

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere

Jan 2, 2018 Other Medical Devices Nationwide View Details →

AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

Vyaire Medical

Class I - Dangerous

The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.

Apr 27, 2017 Infusion Pumps Nationwide View Details →

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

Baxter Healthcare

Class I - Dangerous

Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.

Apr 3, 2018 Infusion Pumps Nationwide View Details →