95,025 total recalls in our database
CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
cGMP deviations
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited functionality of the Artis system up to system failure. Unintended movement of the C-Arm may cause a hazardous situation to the patient, operator, or staff members and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Merits Holdings Co.
Seat baseplate pin has broken in the field.
Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.
Ortho-Clinical Diagnostics
Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be able to produce results for any assays other than sodium, potassium, and chloride. If the customer doesnt have any White Reference Slides in reserve, they cant run the Correction Factor test correctly and get the analyzer running again until they get more White Reference Slides delivered. This could lead to a delay in results for all Vitros assays except for sodium, potassium, and chloride.
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.
Merits Holdings Co.
Seat baseplate pin has broken in the field.
Nextremity Solutions
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system and could cause a delay in procedure and may require another device or alternate surgical method to be used
DJ Orthopedics de Mexico S.A. de C.V.
failed rivet at the chafe tab of arm sling.
Siemens Medical Solutions USA
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
Boston Scientific
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.