Drug recall
Model Numbers: TSCM17CA, TSCM17EA, TSCM17EL, TSCM17EV, TSCM17MA, TSCM17ML, TSCM17MV, TSCM17TA, TSCM34CA…
FDA recall event 98467 · Class II · Thermo Fisher Scientific (Asheville) LLC
Key facts
| Event ID | 98467 |
|---|---|
| Recall numbers | B-0027-2026 |
| Recalling firm | Thermo Fisher Scientific (Asheville) LLC |
| Product type | Biologics |
| Products | Model Numbers: TSCM17CA, TSCM17EA, TSCM17EL, TSCM17EV, TSCM17MA, TSCM17ML, TSCM17MV, TSCM17TA, TSCM34CA, TSCM34EA, TSCM34EL, TSCM34EV, TSCM34MA, TSCM34ML, TSCM34MV, TSCM34TA, TSCM48CA, TSCM48EA… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Thermo Fisher Scientific is recalling the CryoMed Controlled-Rate Freezer and CryoMed Controlled-Rate Freezer with OPC UA because the heater in the unit may not meet factory specifications and could… |
| Initiation date | Dec 13, 2024 |
| Report date | Apr 1, 2026 |
| Termination date | Apr 27, 2026 |
| City | Marietta |
| State | OH |
| Country | United States |
| FEI number | 1523845 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: