Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial ap...
FDA Device Recall #Z-1729-2019 — Class II — May 3, 2019
Recall Summary
| Recall Number | Z-1729-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 3, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Leica Microsystems, Inc. |
| Location | Buffalo Grove, IL |
| Product Type | Devices |
| Quantity | 17,179 devices total (4,835 US, 12,344 OUS) |
Product Description
Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
Reason for Recall
The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries.
Distribution Pattern
Distributed to Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District Of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming. Distributed internationally to Canada.
Lot / Code Information
Leica CM1950 - All devices with serial number: 8092; 8091; 8089 to 8087; 8081; 8078; 8077; 8073; 8071 to 8067; 8064 to 8062; 8058 to 8053; 8051 to 8049; 8047; 8043; 8040; 8038 to 8033; 8031 to 8025; 8023 to 8004; 8002 to 7940; 7938 to 7892; 7890 to 7469; 7466; and all devices with serial number lower than 7466. Leica CM1860/UV - All devices with serial number: 4201; 4200;4196; 4193; 4192; 4188; 4186 to 4184; 4180; 4179; 4173 to 4170; 4168; 4166 to 4160; 4158; 4157; 4154 to 4152; 4149; 4147; 4145 to 4135; 4133 to 4092; 4090; and all devices with serial number lower than 4090. Leica CM1520 - All devices with serial number: 1450; 1448; 1446 to 1444; 1442; 1439; 1437; and all devices with serial number lower than 1437. Leica CM3050 S - All devices with serial number: 7398; 7396 to 7394; 7392; 7398 to 7387; 7385 to 7381; 7379; and all devices with serial number lower than 7379. Leica CM1850UV - 2822; and all devices with serial number lower than 2822. Leica CM1850 - 7265; and all devices with serial number lower than 7265. Leica CM1510 S - 6600; and all devices with serial number lower than 6600. Leica CM1100 - 1418; and all devices with serial number lower than 1418
Other Recalls from Leica Microsystems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0477-2023 | Class II | Leica MICROSYSTEMS M530 OHX, Part Number 104487... | Nov 21, 2022 |
| Z-0476-2023 | Class II | Leica MICROSYSTEMS Provido, Part Numbers 104489... | Nov 21, 2022 |
| Z-0475-2023 | Class II | Leica MICROSYSTEMS Proveo 8, Part Number 104490... | Nov 21, 2022 |
| Z-1849-2022 | Class II | Leica Surgical Operating Microscopes, Arveo, Pa... | Aug 26, 2022 |
| Z-1848-2022 | Class II | Leica Surgical Operating Microscopes, ARveo 8, ... | Aug 26, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.