Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.
All Recalls
95,018 total recalls in our database
impaired functionality of the release liner
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Wright Medical Technology
The tibial tray lock detail is oversized (larger than specification).
Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
ZOLL Circulation
Due to increase in Li-Ion Battery failures
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Siemens Medical Solutions USA
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
MEDLINE INDUSTRIES, LP - Northfield
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.
MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
MEDLINE INDUSTRIES, LP - Northfield
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
W L Gore & Associates
Due to manufacturing records (Release Test Results) indicating "Failed".
impaired functionality of the release liner
MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
MEDLINE INDUSTRIES, LP - Northfield
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
MEDLINE INDUSTRIES, LP - Northfield
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Amazon Basics Executive Desk Chairs
Global Furniture (Zhejiang) Co. Ltd., of China
The chairs' leg base can break, posing fall and injury hazards.
Punisher Adult Cycling Helmets
Unknown Manufacturer
The recalled helmets do not comply with the positional stability and impact attenuation requirements of the U.S. CPSC federal safety standard for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.
Meic power adapters sold with Brother AirSure DF-2 Dynamic Filtration Tabletop Air Purifiers
Unknown Manufacturer
The Meic AC power adapter casing can break while the adapter is being plugged into or removed from an electrical outlet, exposing its metal prongs, posing electrical shock and electrocution hazards.
Goalsetter wall-mounted basketball goals
Goalsetter Systems Inc., of Evansville, Indiana
The basketball goal can detach from the wall and fall to the ground posing a serious impact injury hazard and risk of death.
Horizon T101-05 Treadmills
Unknown Manufacturer
The treadmills can unexpectedly accelerate, change speed, or stop without user input, posing a fall hazard.
LG Energy Solution "RESU 10H" Lithium-Ion Residential Energy Storage System Batteries
Unknown Manufacturer
The home solar panel batteries can overheat, posing a risk of fire and emission of harmful smoke.