Device area
Pathology — companies with FDA recall history
29 companies registered in the Pathology device area that have FDA recall history.
- ABBOTT LABORATORIES
- Advance Dx, Inc.
- Agilent Technologies, Inc
- Azer Scientific, LLC
- BECKMAN COULTER, INC.
- Becton Dickinson and Company
- BIOGENEX LABORATORIES INC.
- Carl Zeiss Inc.
- COPAN ITALIA Spa
- CUSTOM ASSEMBLIES, INC.
- EPITOPE DIAGNOSTICS, INC.
- Exact Sciences Corporation
- FUJIFILM Healthcare Americas Corporation
- GENZYME CORPORATION
- GREINER BIO-ONE NA
- HELENA LABORATORIES, CORP.
- HOLOGIC, INC.
- LetsGetChecked Inc.
- Life Technologies Corporation
- Medline Industries, LP
- MicroCare, LLC
- MILESTONE S.P.A.
- PHADIA AB
- Philips Medical Systems International BV
- RANDOX LABORATORIES, LTD.
- Roche Diagnostics Operations Inc.
- SYSMEX CORPORATION
- THERMO FISHER SCIENTIFIC INC.
- Thomas Scientific, LLC
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.