Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01

Recall Insight

This FDA Devices action (record #Z-1247-2025) was formally reported on March 5, 2025, with the manufacturer initiating the action on January 30, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. LEICA BIOSYSTEMS NUSSLOCH GMBH is listed as the recalling firm, operating out of Nussloch, N/A. Federal records indicate 2 units are affected.

The documented reason for this recall is: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution in the states of Idaho and Ohio. The countries of France, Australia, Belgium, China, Germany, Spain, UK, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, Singapore.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.