Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
All Recalls
95,025 total recalls in our database
Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
Allura CV20, system code 722031
Philips North America
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
TeDan Surgical Innovations
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Smith & Nephew
LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is packaged separately.
A software issue could potentially cause the stand and table movements to be blocked.
Perfect Descentβ’ Auto Belays climbing devices
C3 Manufacturing LLC, of Littleton, Colo.
The belay climbing device can loosen and can cause slack on the rope, allowing the climber to fall. Climbing while tethered to a malfunctioning belay can cause serious injury or death.
Children's Tool Kits
Unknown Manufacturer
The tool belt, hammer and suspenders (model H3044) contain excessive levels of lead, violating the federal lead content standard. In addition, the toy goggles and hardhats do not meet toy safety requirements.
Miles Glass Pitchers with Wood Lid
Unknown Manufacturer
The handle on the pitcher can break, posing a laceration hazard.
Grower's Edge Vaporizers
Unknown Manufacturer
The vaporizers can overheat, and the vaporized materials can pose a burn risk if spilled or cause a fire if they fall onto a combustible surface. The Deluxe model vaporizer also poses an electrical shock hazard if a consumer touches a small copper piece at the base of the vaporizer while in use.
Kawasaki MULE PRO off-highway utility vehicles
Kawasaki Motors Manufacturing Corp. U.S.A, of Lincoln, Neb.
The steering shaft can develop excessive wear and affect steering control resulting in a crash hazard, posing a risk of injury or death.
Kawasaki MULE PRO off-highway utility vehicles
Kawasaki Motors Manufacturing Corp. U.S.A., of Lincoln, Neb.
Debris can ignite on the vehicle's exhaust manifold; and frozen water can block the breather hose allowing oil to leak, posing a fire hazard.
Kids & Koalas baby walkers
Unknown Manufacturer
The baby walkers fail to meet the federal safety standard. Specifically, they can fit through a standard doorway and are not designed to stop at the edge of a step as required by the federal safety standard and they have leg openings that allow the child to slip down until the child's head can become entrapped at the neck. Babies using these walkers can be seriously injured or killed.
Lilly of New York children's winter boots
Wenzhou Jinlong Shoes Co., of China
The boots' sole contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.