🔍 RecallPedia

All Recalls

95,025 total recalls in our database

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28,983
Food
 💊
17,685
Drugs
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38,779
Medical Devices
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9,578
Consumer Products

bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the blower. Oxygen enters through a high pressure inlet. An electronic mixer valve provides for the operator-set concentration. Gas is supplied to the patient via the microprocessor controlled inspiratory valve.

Vyaire Medical

🏥 Medical Devices Class I - Dangerous

The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of non-responsive touch screen.

Nov 25, 2019 Patient Monitors Nationwide View Details →

Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009

Seca

🏥 Medical Devices Class I - Dangerous

It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the worst case, detach from the cart completely. If this occurs the cart can become unstable and tip over, potentially leading to the scale falling from the cart. If a baby is left unattended in a cart, the baby could fall off the scale and be subjected to several serious injuries.

Jun 19, 2019 Other Medical Devices Nationwide View Details →

Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.

Jan 6, 2020 Infusion Pumps Nationwide View Details →

LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.

Organ Recovery Systems

🏥 Medical Devices Class I - Dangerous

Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.

Jan 30, 2020 Other Medical Devices Nationwide View Details →

AIA-360 Automated Immunoassay Analyzer, Product Code 019945

Tosoh Bioscience

🏥 Medical Devices Class I - Dangerous

A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.

Jan 10, 2020 Other Medical Devices View Details →

CareFusion Alaris Syringe Module, Model 8110

CareFusion 303

🏥 Medical Devices Class I - Dangerous

1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders

Feb 4, 2020 Surgical Instruments Nationwide View Details →

PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.

Polymer Technology Systems

🏥 Medical Devices Class I - Dangerous

The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

Jan 21, 2020 Diagnostic Equipment Nationwide View Details →

Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cartridge) and 15099590625597 (400 tests/cartridge)

Beckman Coulter

🏥 Medical Devices Class I - Dangerous

It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.

Aug 15, 2019 Diagnostic Equipment View Details →

McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.

Medtronic, PLC

🏥 Medical Devices Class I - Dangerous

Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen

Jan 28, 2020 Infusion Pumps Nationwide View Details →

Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The Connect OR Cart is a mobile, medical-grade cart intended to store and transport components of minimally invasive and open-field imaging systems such as the Stryker Advanced Imaging Modality (AIM) System, PINPOINT Endoscopic Fluorescence Imaging System, or SPY Portable Handled Imaging (SPY-PHI) System) during intraoperative use. The Cart also provides power, video, and data connections to the components.

Stryker

🏥 Medical Devices Class I - Dangerous

There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. The product is not manufactured to specifications and is positioned on the incorrect side that may lead to monitor falling from the monitor arm and a risk of user injury.

Apr 23, 2019 Diagnostic Equipment Nationwide View Details →

Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)

Beckman Coulter

🏥 Medical Devices Class I - Dangerous

It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.

Aug 15, 2019 Diagnostic Equipment View Details →