All Recalls

The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.

The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

Due to product outer packaging incorrectly labeled.

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

Incorrect blister labelling.

The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

The recalled lights violate the mandatory federal regulations for consumer products designed to use button cell or coin batteries because the strip lights allow easy access by children to the lithium coin batteries, posing an ingestion hazard. In addition, the recalled products do not have the required warnings. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.

The recalled shape sorter car toys contain balls that violate regulations banning small parts in toys intended for children under three years of age because they are a choking hazard, and can cause serious injury or death.

The controller on the recalled ride-on dump trucks can overheat, posing fire and burn hazards.

The recalled butane torches violate the mandatory federal regulations for multipurpose lighters because they do not have the required child-resistant mechanisms, posing a risk of serious burn injuries or death to children.

The recalled ride-on toys can overheat due to improper wiring, posing a fire hazard.