LEICA BIOSYSTEMS NUSSLOCH GMBH: Medical Device Recall in 2024 - (Recall #: Z-0086-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples

Product Classification:

Class II

Date Initiated: September 4, 2024

Date Posted: October 23, 2024

Recall Number: Z-0086-2025

Event ID: 95323

Reason for Recall:

As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.

Status: Ongoing

Product Quantity: 13 units

Code Information:

a) Material Number 1491510C002, UDI/DI (01)04049188002945, Serial Numbers: 5359022006, 5367012006, 5913, 5996, 5065, 5625022007, 5467072006, 5901, 5108122004, 5330, 5269, 5667; b) Material Number 1491510C003, UDI/DI (01)04049188002891. Serial Numbers: 5537

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated