Hawaii recalls

Some GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood analyzer are experiencing increased errors during startup that cause the cartridge to eject prematurely. This may require staff to insert a new cartridge and repeat the startup process, which can delay test results. The device's built-in quality monitoring system (iQM2) continues to verify results, so cartridges that pass validation can remain in use.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer are experiencing repeated error messages during startup that cause the cartridge to eject. This may delay test results and require inserting replacement cartridges. The affected cartridges are from specific lot numbers manufactured in late 2025.

Instrumentation Laboratory has identified that GEM PAK cartridges for the GEM Premier 5000 blood gas analyzer may fail quality checks during startup, causing the cartridge to eject. This can happen multiple times in a row, which delays test results. The cartridges that pass quality checks after startup can continue to be used.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer are experiencing increased errors during warm-up that cause them to eject unexpectedly. This can require repeated cartridge replacements and may delay test results. Most cartridges continue to work normally, but consecutive ejections could disrupt lab operations.

Some GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood gas analyzer may reject during the warm-up process, requiring replacement cartridges to be inserted. This can delay test results and may require doctors to reassess patient care once results are available. The issue affects specific lot numbers distributed worldwide.

Some GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood gas analyzer are ejecting repeatedly during warm-up due to detection errors. This can delay test results and require staff to insert new cartridges multiple times. The device's quality control system (iQM2) will catch problems, but consecutive ejections may slow lab operations.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer may fail to detect process control solution during warm-up, causing the cartridge to eject unexpectedly. This can delay test results and require staff to insert a new cartridge. Most cartridges continue to work normally, but consecutive failures may disrupt lab operations.

Instrumentation Laboratory has identified that some GEM PAK cartridges (part no. 00055407511) for the GEM Premier 5000 blood analyzer may fail quality checks more frequently during startup, causing the cartridge to be ejected. This can delay test results and may require multiple cartridge replacements. The GEM Premier 5000's built-in quality monitoring system (iQM2) will catch and reject any cartridges that do not pass validation, so cartridges that complete the validation process remain safe to use.

Some GEM Premier 5000 PAK cartridges (Part No. 00055407510) may fail to detect process control solution during warm-up, causing the cartridge to eject. This can require staff to insert a new cartridge and may delay test results. Most cartridges work normally, but some lots are experiencing repeated ejection problems.

Some GEM PAK cartridges (Part No. 00055407508) for the GEM Premier 5000 blood analyzer may eject repeatedly during warm-up due to detection errors. This can delay test results and require staff to insert new cartridges multiple times. Most cartridges work normally, but some batches show higher error rates.

Certain cartridges (PAKs) for the GEM Premier 5000 blood analyzer may fail to detect process control solution during startup, causing the cartridge to eject and need replacement. This can delay test results. The issue affects 28 specific lot numbers distributed worldwide.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer may fail to detect process control solution during warm-up, causing the cartridge to eject and need replacement. This can delay test results and may require doctors to reassess patient care once results are available.

Certain cartridges (GEM PAKs) for the Instrumentation Laboratory GEM Premier 5000 blood analyzer may fail to detect a required control solution during startup, causing the cartridge to be ejected. This can happen multiple times in a row, delaying test results. Many cartridges work normally, but affected lots may cause operational delays.

Instrumentation Laboratory GEM Premier 5000 PAK cartridges (part number 00055360008) in certain lots may fail to detect process control solution during warm-up, causing the cartridge to eject unexpectedly. This can delay test results and require staff to insert a new cartridge. The quality control system will catch cartridges that fail validation, and affected cartridges can still be used if they pass validation.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer may fail to detect process control solution during warm-up, causing the cartridge to eject and need replacement. This can delay test results. The issue affects 51 cartridges from specific lot numbers distributed worldwide.

Waldemar Link GmbH & Co. KG is recalling specific lots of the Endo-Model Replacement Plateau (Item 15-0027/16), a surgical implant used in joint replacement procedures. The bushing on the plateau screw may detach from the screw shaft due to a crack, which could affect the implant's stability during or after surgery.

Waldemar Link GmbH & Co. KG is recalling Endo-Model Replacement Plateau screws (Item Number 15-0027/12) because the bushing could detach from the screw shaft due to a crack. This could affect the stability of the implant. One affected unit has been identified outside the US.

Waldemar Link GmbH & Co. KG is recalling the Endo-Model Replacement Plateau (Item Number 15-0027/11) because the bushing on the plateau screw could detach from the screw shaft due to a crack. This could affect the stability of the implant. Two units outside the US have been identified, with no injuries reported to date.

Waldemar Link GmbH & Co. KG is recalling certain Endo-Model Replacement Plateau screws (Item Number 15-8521/15) because the bushing could detach from the screw shaft due to a crack. This could affect the function of the implant. Four units have been identified outside the United States.

Waldemar Link GmbH & Co. KG is recalling certain Endo-Model Replacement Plateau screws (Item Number 15-8521/11) because the bushing could detach from the screw shaft due to a crack. This could affect the function of the implant. No injuries have been reported.

Waldemar Link GmbH & Co. KG is recalling certain Endo-Model Replacement Plateau implants (Item Number 15-8521/09) because the bushing on the plateau screw may detach from the screw shaft due to a crack. This could affect the stability of the implant. Eight units have been identified with this issue outside the United States.

Waldemar Link's Endo-Model Replacement Plateau screws (Item 15-8030/12) may have a bushing that can detach from the screw shaft due to a crack in the screw. This could affect the stability of knee replacement implants. Four units have been identified in this recall, primarily distributed outside the United States.

Waldemar Link GmbH & Co. KG is recalling certain Endo-Model Replacement Plateau screws (Item Number 15-2836/11) because the bushing holding the screw together could fracture and detach. This affects 7 units distributed outside the United States in multiple countries. No injuries have been reported.

Waldemar Link GmbH & Co. KG is recalling a specific lot of Endo-Model Replacement Plateau knee implant screws (Item 15-2835/12, Lot 241210/1809). The bushing on the screw can potentially detach from the shaft due to a crack, which could affect the stability of the implant.

Waldemar Link GmbH & Co. KG is recalling specific lots of the Endo-Model SL Connection Component with PE-Plateau (Item 16-2840/07) used in orthopedic implants. The bushing on the plateau screw could detach from the screw shaft due to a longitudinal fracture, which could affect implant stability. Thirty-one units have been distributed outside the US.

Waldemar Link GmbH & Co. KG is recalling specific lots of Endo-Model SL Connection Component implant screws. The bushing on the plateau screw could detach from the screw shaft due to a crack, which could affect implant stability.

Waldemar Link GmbH & Co. KG is recalling Endo-Model Replacement Plateau screws (Item Number 15-0027/15) because the bushing could detach from the screw shaft due to a crack. This could affect the stability of the implant. Three units with lot number 2549190 were distributed worldwide, including in the U.S., Canada, and Europe.

Waldemar Link GmbH & Co. KG is recalling specific lots of the Endo-Model SL Connection Component (Item 16-2840/05) used in orthopedic implants. A bushing on the plateau screw could detach from the screw shaft due to a crack, which could affect implant stability. One unit was distributed in the U.S. (New Jersey); the remaining 43 units were distributed internationally.

Exactech has recalled 596 Equinoxe Core Instrument Kits (model KIT-311X) because the impactor handle may be missing a cross-pin. This defect could affect the handle's stability during surgical use. No injuries have been reported.

Exactech's Equinoxe Ergo Ergo Modular Impactor Handle (model 321-09-05) may be missing an internal cross-pin. This defect could affect the handle's stability or function during surgical use. The recall affects 120 units distributed across the US and nine other countries.