Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.
All Recalls
95,114 total recalls in our database
US-dates between the product package label and the bar code display.
Multiple or incorrect expiration dates were provided on the affected designation labels.
Alaris System PC Unit Model 8015
CareFusion 303
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable range. The acceptable average linear shrinkage ranges between 1.225 to 1.275. The production lot being recalled has a linear shrinkage rate of 2.251 which is above the acceptable range.
The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion.
SICAT IMPLANT V2.0
SICAT GMBH & CO. KG
A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.
There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis.
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Intuitive Surgical
One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Medical Components, Inc
Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious injury or death.
Label has the incorrect size for the tracheotomy tube.
ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
Intuitive Surgical
One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.
Merge PACS
Merge Healthcare
Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
Monoprice Category 6 Ethernet Bulk CMR Communications Cables
Unknown Manufacturer
The cables do not meet the flammability requirements of the UL 1666 voluntary safety standard, posing a fire hazard when the cable is exposed to a flame.
Dual Fuel Portable Generators
Unknown Manufacturer
The recalled portable generators can leak fuel, posing a fire and burn hazard.
Industrial Three-Panel Mirrors
Unknown Manufacturer
The mirror panels can become loose, detach from the backing and fall, posing an injury hazard.
31 Medique Over-the-Counter drugs from the product lines Medi-First, Medi-First Plus, Medique, Dover, Otis Clapp, and Ecolab
Medique, of Fort Myers, Fla.
The over-the-counter products contain regulated substances which must be in child resistant packaging when being used in the household as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
Organic Aromas Wintergreen Essential Oil
Organic Aromas, of Taiwan
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
Traction elevators
Residential Elevators Inc., of Crawfordville, Fla.
The elevator cab can rise unexpectedly to the top of the elevator shaft and abruptly stop, posing an impact hazard to any occupants in the elevator cab.