🏥 Medical Devices Class I - Dangerous
During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.
Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
Dental EZ Group Star Dental Division
🏥 Medical Devices Class I - Dangerous
The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
Smith & Nephew, Inc. Endoscopy Division
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to breach in sterile barrier
Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DI
🏥 Medical Devices Class I - Dangerous
Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
The assay is demonstrating a higher frequency of results greater than 10 ng/mL compared to alternate platforms.
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
RAPIDComm¿ 5.0 Screen Layout will display incorrect test names
🏥 Medical Devices Class I - Dangerous
Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear casters may become loose.
ACL TOP 300 CTS, automated coagulation laboratory instrument.
Instrumentation Laboratory
🏥 Medical Devices Class I - Dangerous
Potential for sample misidentification.
🏥 Medical Devices Class I - Dangerous
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
ACL TOP CTS, automated coagulation laboratory instrument.
Instrumentation Laboratory
🏥 Medical Devices Class I - Dangerous
Potential for sample misidentification.
Dream On Me Dinah High Chairs
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The leg or side opening of the chair can allow a child's body to pass through and become entrapped at the neck or fall from the chair. This poses a strangulation and fall hazard to young children.
Mountain bikes
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The brakes can fail to stop riders within the distances required by federal regulation, posing a crash hazard.
Donovan Bar Stools
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The bar stool footrest can break, posing a fall hazard to the user.
Sparrow Cribs
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The slats/spindles and top rail can detach from the cribs and pose an entrapment hazard to a child.
GT downhill mountain bicycles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The wheel hubs can break and cause the brake system to fail, posing crash and injury hazards to the consumer.
USB car charger adapters, power adapters and 8-pin charger cables
Shenzhen Qiwei Electronic Co., Ltd., Guangdong, China
🏠 Consumer Products Class I - Dangerous
Improperly mounted plug blades, and inadequate electronic circuitry create a fire and electrical shock hazard to consumers.
Banana Puddin' Y'all Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Koogee-Queen Anne
🍎 Food Class I - Dangerous
During an FDA inspection the firm was notified that their bulk product lacked labels. Due to the lack of ingredient statement, the firm failed to declare direct allergens for the products. The products also lacked the declaration that they are packaged in a facility that processes peanuts, tree nuts, wheat, milk and eggs.