CustMbite, Model Number CBT-SRS-UL
Dental Choice Holding
🏥 Medical Devices Class I - Dangerous
The device was marketed and sold in the US without FDA clearance.
All Recalls
95,102 total recalls in our database
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Aesculap Implant Systems
🏥 Medical Devices Class I - Dangerous
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
🏥 Medical Devices Class I - Dangerous
Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
Craftmatic Model 1 Base for Dual Bed Configurations
Craftmatic Industries
🏥 Medical Devices Class I - Dangerous
A potential for dual-configured beds to separate or slip away from one another.
🏥 Medical Devices Class I - Dangerous
There is the potential that during implant deployment, the device may not properly deliver a implant.
Turbett Surgical Container, TS1500
Turbett Surgical
🏥 Medical Devices Class I - Dangerous
Devices were subject to unapproved rework processes.
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
🏥 Medical Devices Class I - Dangerous
Product may be mislabeled.
Merlin.net model MN5000 Software
St. Jude Medical, Cardiac Rhythm Management Division
🏥 Medical Devices Class I - Dangerous
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
🏥 Medical Devices Class I - Dangerous
Product may be mislabeled.
MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
stability failure
Legacy Base for Dual Bed Configurations
Craftmatic Industries
🏥 Medical Devices Class I - Dangerous
A potential for dual-configured beds to separate or slip away from one another.
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
North American Diagnostics
🏥 Medical Devices Class I - Dangerous
Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.
🏥 Medical Devices Class I - Dangerous
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
DeWALT 12-inch Sliding Compound Miter Saws
Unknown Manufacturer
🏠 Consumer Products Class III - Low Risk
The miter saw's rear safety guard can break or detach, posing an injury hazard due to projectiles that can strike the user and bystanders and a laceration hazard to the user who could come into direct contact with the saw blade.
Cordless hedge trimmers
Unknown Manufacturer
🏠 Consumer Products Class III - Low Risk
The teal-colored guard on the recalled hedge trimmer's shear blade is missing, posing a laceration hazard to users.
🍎 Food Class I - Dangerous
Detectable levels of Per- and polyfluoroalkyl substances (PFAS).
Simply Nature Organic Spring Mix 16 oz. Marketside Spring Mix 11 oz. and 5 oz.
Dole Fresh Vegetables
🍎 Food Class I - Dangerous
Potential to contain hairy nightshade.
🍎 Food Class I - Dangerous
Sauce found to have a pH higher than specifications.
🍎 Food Class I - Dangerous
Listeria monocytogenes contamination.