🏥 Medical Devices Class I - Dangerous
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Non-sterile product was shipped to customers labelled as sterile.
🏥 Medical Devices Class I - Dangerous
There is a risk that the device can start a fire if flammable liquids contact and enter the device.
🏥 Medical Devices Class I - Dangerous
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
🏥 Medical Devices Class I - Dangerous
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
🏥 Medical Devices Class I - Dangerous
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
🏥 Medical Devices Class I - Dangerous
Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally replaced during annual preventative maintenance. Alarm Situations: During System Self-Test: Alarm code B1215 (ARPS Self-Test failure); During Therapy: B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test Failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), B1540 (Effluent Filter Pod Reposition Failure). If an alarm occurs, it may lead to delay or interruption of therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur.
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.
BioFire Diagnostics
🏥 Medical Devices Class I - Dangerous
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
Shanghai United Imaging Healthcare Co.
🏥 Medical Devices Class I - Dangerous
There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.
🏥 Medical Devices Class I - Dangerous
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
Nihon Kohden America
🏥 Medical Devices Class I - Dangerous
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
🏥 Medical Devices Class I - Dangerous
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
🏥 Medical Devices Class I - Dangerous
The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions.
🏥 Medical Devices Class I - Dangerous
Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.
🏥 Medical Devices Class I - Dangerous
A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.
Hillsdale Furniture Jennings Counter and Bar Stools
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The stool seat can break off the base, posing a fall hazard.
Lifetime Products 6-foot Seminar Tables
Kingtec Group Vietnam Co. LTD, of Ben Cat Town, of Binh Duong Province, Vietnam
🏠 Consumer Products Class II - Moderate
The brace arms can fail to lock the table legs into place and the table can collapse, posing an injury risk to consumers.
Cabina Bunk Beds
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The screws that hold the bed's mattress foundation to the bed's guardrails can be loose and the mattress foundation can fall, posing a fall risk to children in the bunk bed.
Model Year 2020-2021 RANGER 1000, RANGER CREW 1000, RANGER XP 1000, and RANGER CREW XP 1000 and Model Year 2020 ProXD 2000G, ProXD 2000G H, ProXD 4000G, and ProXD 4000G H
Polaris Inc., of Medina, Minn.
🏠 Consumer Products Class II - Moderate
The throttle pedal can return to the idle position more slowly than anticipated once the pedal is released or stick in the depressed position, posing a crash hazard.
Thai Peanut Sauce, 12 fl. oz. (355ml), UPC code #643558406919
Barbara's Orchard/Delicae Gourmet
🍎 Food Class I - Dangerous
Undeclared allergen: Shrimp