Class I - Dangerous
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
ðĨ
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
Siemens Medical Solutions USA
Class I - Dangerous
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
NeuMoDx Molecular
Class I - Dangerous
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Northgate Technologies
Class I - Dangerous
Product labeled incorrectly.
Class I - Dangerous
The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
Class I - Dangerous
Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
Class I - Dangerous
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Ion Beam Applications S.A.
Class I - Dangerous
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Class I - Dangerous
Incorrect product labeling.
Class I - Dangerous
Software anomaly was identified.
3.2MM Pellet Insertion Tray Catalog Number: B9743
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
Becton, Dickinson and Company, BD Biosciences
Class I - Dangerous
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
3,65 m Extension Set with Luer-lock Connector
Baxter Healthcare
Class I - Dangerous
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
15 Liters Drain Bag
Baxter Healthcare
Class I - Dangerous
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Nerve Block Tray Catalog Number: 8415
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Single Shot Epidural Tray Catalog Number: 8417
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
APD Drain Manifold
Baxter Healthcare
Class I - Dangerous
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products