Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Search Product Recalls

Try:····

Filters

Time Period

All Time Last 30 Days Last 90 Days Last Year

State

Showing 7701–7720 of 11714 results

Sort:

Newest first Oldest first

PCRopsis Support (Entopsis) - Label Misleading (2023)

Presence of misleading label statements on the product label.

Moderate

FDAFeb 21, 2023Nationwide• Entopsis Inc.

PCRopsis Lysis Beads (Entopsis) - Label Misleading (2023)

Presence of misleading label statements on the product label.

Moderate

FDAFeb 21, 2023Nationwide• Entopsis Inc.

SMR TT Hybrid Glenoid (Limacorporate) - Marker Absence (2023)

Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.

Moderate

FDAFeb 21, 2023MO• Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy

Evamist (Padagis) – content uniformity failure (2023)

Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.

Class IIILow

FDAFeb 21, 2023Nationwide• Padagis US LLC

Moberg CNS Monitor (Moberg) - Battery Leakage (2023)

Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC

Moderate

FDAFeb 20, 2023Nationwide• Moberg Research, Inc.

2D Perfusion (Philips) - Signal Processing (2023)

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

Moderate

FDAFeb 20, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

SmartPerfusion (Philips) - Signal Processing (2023)

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

Moderate

FDAFeb 20, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Raystation Treatment Planning (RaySearch) - Collimator Angle (2023)

It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.

Moderate

FDAFeb 17, 2023Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Arjo Portable Scale Adaptor (Arjohuntleigh) - Strap Detachment (2023)

Some Arjo Portable Scale Adaptors have been assembled with straps that have a potential to detach.

Moderate

FDAFeb 17, 2023NY, OH• Arjohuntleigh Magog, Inc.

Agilent Resolution Kit (Agilent) - Instruction Issue (2023)

Distributed sample collection kit with an unapproved instruction for use.

Moderate

FDAFeb 17, 2023Nationwide• AGILENT TECHNOLOGIES INC./US

Thermage CPT System (Solta Medical) - Calibration Problem (2023)

A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.

Moderate

FDAFeb 16, 2023MD• Solta Medical Inc

Infinity Occipitocervical Screw (Medtronic) - Material Strength (2023)

Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Moderate

FDAFeb 16, 2023Nationwide• Medtronic Sofamor Danek USA Inc

Flex-Neck Catheter Kit (Merit) - Unintended Distribution (2023)

Product that was built for design verification testing was inadvertently distributed to customers.

Moderate

FDAFeb 15, 2023Nationwide• Merit Medical Systems, Inc.

Attune Posterior Tibial Insert (DePuy) - Irradiation Dosage (2023)

The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

Moderate

FDAFeb 15, 2023Nationwide• DePuy Orthopaedics, Inc.

Attune Revision Tibial Insert (DePuy) - Irradiation Dosage (2023)

Moderate

FDAFeb 15, 2023Nationwide• DePuy Orthopaedics, Inc.

FoundationOne CDx (Foundation Medicine) - Claim Error (2023)

An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.

Moderate

FDAFeb 15, 2023Nationwide• Foundation Medicine, Inc.

KLS Martin Battery Pack (Pro-Dex) - Expiration Mixup (2023)

Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.

Low

FDAFeb 15, 2023FL• Pro-Dex Inc

Brainlab ExacTrac Software (Brainlab) - Breath Hold Functionality (2023)

Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template

Low

FDAFeb 14, 2023Nationwide• Brainlab AG Olof-palme-str. 9 Munich Germany

BD Pyxis MedStation (CareFusion) - Drawer Failure (2023)

Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,

Moderate

FDAFeb 14, 2023Nationwide• CareFusion 303, Inc.

BD Pyxis MedStation Tower (CareFusion) - Door Latch Failure (2023)

Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.

Moderate

FDAFeb 14, 2023AL, AK, AZ +49 more• CareFusion 303, Inc.

1...384 385386387 388...586

Page 386 of 586Next