FDA medical device recalls

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.

Penner Patient Care, Inc. is recalling certain Penner Pacific Bathing Spa units (Model 860010-1L) because they do not have the required unique device identifier marked on them. This identifier is needed for proper tracking and safety oversight. No injuries have been reported.

Certain Penner Pacific Bathing Spa units (Models 760010-1 and 770010-1) were distributed without a required unique device identifier (UDI) label. This label helps health authorities track and manage medical devices. The FDA has identified 190 affected units by serial number.

Penner Patient Care, Inc. is recalling certain Penner Pacific Bathing Spa models because they do not have the required unique device identifier (UDI) label. This makes it difficult to track the device for safety purposes. No injuries have been reported.

Penner Patient Care, Inc. is recalling certain Penner Pacific Bathing Spa models (390010-1, 390010-X, 390010-2) because they do not have the required unique device identifier. This is a regulatory compliance issue. About 25 units are affected.

Penner Patient Care, Inc. is recalling certain Penner Pacific Bathing Spa units because they do not have the required unique device identifier (UDI) label. This is a regulatory compliance issue. No injuries have been reported.

Certain Penner Pacific Bathing Spa models do not have a unique device identifier (UDI) as required by FDA regulations. This affects 206 units with specific serial numbers distributed nationwide. No injuries have been reported.

Penner Patient Care, Inc. is recalling certain Penner Pacific Bathing Spa units (Model 360020-1P) because they do not have a unique device identifier (UDI) as required by federal regulations. This affects 45 units distributed nationwide. No injuries have been reported.

The device does not bear a unique device identifier.

Certain Penner Pacific Bathing Spa models do not have a unique device identifier (UDI) as required by federal regulations. This affects 643 units with specific serial numbers. No injuries have been reported.

Penner Patient Care is recalling certain Penner Pacific Bathing Spa models because they do not have the required unique device identifier marked on them. This identifier helps track and manage the device if problems arise. No injuries have been reported.

Raz Design mobile shower commode chairs may have improperly engaged rear seat brackets due to a vendor modification. This could cause the seat to become loose or detach during use. The recall affects multiple Raz models nationwide.