The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Use this page to screen for a possible match. Use the linked official notice before you stop use, throw away, return, repair or schedule service.
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Check device name, UDI, model, lot, serial and software version.
Review the hazard, consequence, risk level and whether the notice says to stop using, stop eating or keep the item away from children.
Look for refund, repair, replacement, disposal, software update, dealer service or company contact instructions.
Open the official source before making a safety decision, especially for vehicles, food, baby products and medical devices.
Device recalls can depend on UDI, model, catalog number, lot, serial number, software version or implant card details. Match the label before changing device use.
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Use the official notice for remedy instructions. Product recall remedies may include repair, replacement, refund, disposal, software update, dealer service or a stop-use instruction.
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Compare UDI, product code, model, catalog number, lot, serial number and software version before changing device use.
Check UPCs, lot codes, serial numbers, model numbers, best-by dates, date codes, VIN ranges, production dates or official campaign numbers when available.
Hazards can involve injury, fire, choking, contamination, undeclared allergens, crash risk, device failure, electrical shock or incorrect labeling.
Confirm final instructions in the linked official notice before returning, repairing, disposing, stopping use, stopping consumption, contacting the company or scheduling service.
Medical device recalls can depend on UDI, product code, software version, model, lot or serial number.
Use the hazard, consequence and risk level to understand whether the product should be stopped immediately or handled through normal recall instructions.
Recall remedies differ by agency and product type. The official notice is the final source for repair, refund, replacement, disposal, dealer service or stop-use steps.
This page helps you review public recall details in one place. Always use the linked agency or company notice before making a safety decision.
| Product Recall | Source | Type | Risk | Date | Action |
|---|---|---|---|---|---|
|
Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.
Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.
|
FDA
Z-0293-2027
|
Medical Device | High |
Nov 4, 2026
Recall: Oct 6, 2026
|
Details |
|
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart.
|
FDA
Z-0286-2027
|
Medical Device | High |
Nov 4, 2026
Recall: Sep 3, 2026
|
Details |
|
Philips Azurion 7 B12. Model Numbers: 722067, 722225.
Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.
|
FDA
Z-0296-2027
|
Medical Device | High |
Nov 4, 2026
Recall: Oct 6, 2026
|
Details |
|
PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.
Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.
|
FDA
Z-0307-2027
|
Medical Device | High |
Nov 4, 2026
Recall: Sep 9, 2026
|
Details |
|
Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.
|
FDA
Z-0299-2027
|
Medical Device | High |
Nov 4, 2026
Recall: Oct 6, 2026
|
Details |
|
Carevo, Height-adjustable shower trolley, Model Number BAC1111-01
The side support of the shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling. If the side support is not fully locked and an additional force is applied by the caregiver on the handle (e.g., during turning or repositioning), the panel may open unintentionally, which can lead to a resident/patient fall and serious injury, such as head injury, fractures, or other trauma resulting from a patient fall.
|
FDA
Z-0315-2027
|
Medical Device | High |
Nov 4, 2026
Recall: Sep 25, 2026
|
Details |
Compare the product name, brand, model, UPC, lot code, serial number, VIN, date code, package size, retailer and distribution details with the official notice. All key details should match.
Stop using, feeding, driving or consuming the product when the notice says to do so, then follow the official remedy for repair, replacement, refund, disposal, service or company contact.
No. This site helps you review public recall details. Use the linked official notice as the final source for affected products and safety instructions.
Agencies and companies may update notices with expanded products, corrected codes, new risk classifications, remedy availability or additional distribution details.