Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    a) Material Number 14045227382, UDI/DI 04049188075840, Serial Numbers: 1198121999, 383051996; b) Material Number 14901900100, UDI/DI 04049188003324, Serial Numbers: 703111997, 1018021999, 1538042001, 2058, 629071997, 2994, 1170111999, 3686102007, 3698; c) Material Number 14901900700, UDI/DI 04049188003300, Serial Numbers: 1267032000, 2602062004, 1577052001, 1679092001, 2542042004, 1771, 1885032002, 2682092004, 2376112003, 2774122004, 1114, 1749112001, 1997072002; d) Material Number 1491900UVU2, UDI/DI 04049188002570, Serial Numbers: 3243052006
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
LEICA BIOSYSTEMS NUSSLOCH GMBH
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples

Product Codes/Lot Numbers:

a) Material Number 14045227382, UDI/DI 04049188075840, Serial Numbers: 1198121999, 383051996; b) Material Number 14901900100, UDI/DI 04049188003324, Serial Numbers: 703111997, 1018021999, 1538042001, 2058, 629071997, 2994, 1170111999, 3686102007, 3698; c) Material Number 14901900700, UDI/DI 04049188003300, Serial Numbers: 1267032000, 2602062004, 1577052001, 1679092001, 2542042004, 1771, 1885032002, 2682092004, 2376112003, 2774122004, 1114, 1749112001, 1997072002; d) Material Number 1491900UVU2, UDI/DI 04049188002570, Serial Numbers: 3243052006

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0088-2025

Related Recalls

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.

Sep 4, 2024 Other Medical Devices Nationwide View Details →

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.

Sep 4, 2024 Other Medical Devices Nationwide View Details →