Consumer Product Recalls

Hazard: The recalled sling carriers violate the federal safety regulations for sling carriers, including requirements for structural integrity and occupant retention, posing a fall hazard to babies.

Hazard: The recalled baby gates violate the federal safety regulations for expansion gates and expandable enclosures. For the versions with a pet door, a child's torso can fit through the secondary opening and, for the other versions that are adjustable, a child's torso can fit through the opening between the gate slat and side wall. These violations pose an entrapment hazard to children.

Hazard: The recalled mower decks cannot be secured in the upright or tilted position by the locking pins during maintenance or service, posing a crush hazard.

Hazard: The recalled products violate the mandatory federal regulations for consumer products containing button cell or coin batteries, because the sliding doors' sensor panel and the windows' remote control have button cell batteries that can be easily accessed by children. This poses an ingestion hazard. In addition, the recalled products do not have the required warnings. When button cell batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.

Hazard: The recalled sweatshirts and hoodies violate the federal flammability standard for clothing, posing a burn hazard to consumers.

Hazard: During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.

Hazard: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

Hazard: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

Hazard: Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.

Hazard: Complaints have been received regarding post-operative implant collapse.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Hazard: 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.

Hazard: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

Hazard: Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

Hazard: Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.

Hazard: Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.

Hazard: Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.