| Nipro Renal Solutions USA, Corporation - FDA Warning Letter (2026-07-24) | | 2026-07-24 |
| Koven Technologies, Inc. - FDA Warning Letter (2026-07-21) | | 2026-07-21 |
| Happiest Baby, Inc. - FDA Warning Letter (2026-06-15) | | 2026-06-15 |
| Nihon Kohden Digital Health Solutions, LLC - FDA Warning Letter (2026-06-12) | | 2026-06-12 |
| AseptiKits, LLC - FDA Warning Letter (2026-06-04) | | 2026-06-04 |
| BlephEx, LLC - FDA Warning Letter (2026-06-03) | | 2026-06-03 |
| Linemaster Switch Corporation - FDA Warning Letter (2026-05-27) | | 2026-05-27 |
| ZIIP, Inc. - FDA Warning Letter (2026-05-22) | | 2026-05-22 |
| 3B Medical, Inc. dba Reach Health, Inc. - FDA Warning Letter (2026-05-20) | | 2026-05-20 |
| BMC Medical Co., Ltd. - FDA Warning Letter (2026-05-20) | | 2026-05-20 |
| Skytron, LLC - FDA Warning Letter (2026-05-19) | | 2026-05-19 |
| ZOLL Medical Corporation - FDA Warning Letter (2026-04-30) | | 2026-04-30 |
| Unetixs Vascular, Inc. - FDA Warning Letter (2026-04-15) | | 2026-04-15 |
| Medline Industries, LP - FDA Warning Letter (2026-03-25) | | 2026-03-25 |
| Longhorn Vaccines and Diagnostics LLC - FDA Warning Letter (2026-02-26) | | 2026-02-26 |
| IsoTis OrthoBiologics, Inc. - FDA Warning Letter (2026-02-24) | | 2026-02-24 |
| ExThera Medical Corporation - FDA Warning Letter (2026-02-06) | | 2026-02-06 |
| Diasol, Inc. - FDA Warning Letter (2026-01-29) | | 2026-01-29 |
| Beta Bionics, Inc. - FDA Warning Letter (2026-01-28) | | 2026-01-28 |
| Beta Bionics, Inc. - FDA Warning Letter (2026-01-28) | | 2026-01-28 |
| Flextronics America LLC - FDA Warning Letter (2026-01-27) | | 2026-01-27 |
| Abbott Diabetes Care, Inc. - FDA Warning Letter (2026-01-23) | | 2026-01-23 |
| Unomedical Device S.A. de C.V. - FDA Warning Letter (2026-01-08) | | 2026-01-08 |
| Meridian Bioscience, Inc - FDA Warning Letter (2025-12-22) | | 2025-12-22 |
| Exactech, Inc. dba Advita Ortho - FDA Warning Letter (2025-12-19) | | 2025-12-19 |
| MAST Biosurgery USA, Inc. - FDA Warning Letter (2025-12-17) | | 2025-12-17 |
| TG Supply LLC d/b/a TransGuy Supply - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| Flux Lab Pte. Ltd. d/b/a The Fluxion - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| Marli Washington Design, LLC - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| FLAVNT Streetwear, LLC - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| Early to Bed, Inc. - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| GenderBender LLC - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| TomboyX, PBC - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| Philadelphia 7, Inc d/b/a Passional Boutique - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| TOMSCOUT - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| For Them, Inc. - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| ShapeShifter Apparel, LLC - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| Trans-Missie B.V. - FDA Warning Letter (2025-12-16) | | 2025-12-16 |
| Palamur Biosciences Private Limited - FDA Warning Letter (2025-12-11) | | 2025-12-11 |
| ASP Global, LLC. dba Anatomy Supply Partners, LLC. - FDA Warning Letter (2025-12-09) | | 2025-12-09 |
| Physitemp Instruments, LLC - FDA Warning Letter (2025-11-12) | | 2025-11-12 |
| Envoy Medical Inc. - FDA Warning Letter (2025-11-11) | | 2025-11-11 |
| Hong Qiangxing Shenzhen Electronics Limited - FDA Warning Letter (2025-10-28) | | 2025-10-28 |
| Qianjiang Kingphar Medical Material Co Ltd. - FDA Warning Letter (2025-10-03) | | 2025-10-03 |
| Contec Medical Systems Co., Ltd. - FDA Warning Letter (2025-10-02) | | 2025-10-02 |
| Technological Medical Advancements LLC - FDA Warning Letter (2025-09-26) | | 2025-09-26 |
| Insung Medical Co. Ltd. - FDA Warning Letter (2025-09-23) | | 2025-09-23 |
| LifeVac, LLC - FDA Warning Letter (2025-09-18) | | 2025-09-18 |
| Royal Philips - FDA Warning Letter (2025-09-09) | | 2025-09-09 |
| Avertix Medical, Inc. - FDA Warning Letter (2025-09-03) | | 2025-09-03 |
| The Richline Group, Inc. - FDA Warning Letter (2025-08-25) | | 2025-08-25 |
| SeniorLife Technologies, Inc. - FDA Warning Letter (2025-08-21) | | 2025-08-21 |
| Miach Orthopaedics - FDA Warning Letter (2025-08-19) | | 2025-08-19 |
| LeMaitre Vascular, Inc. - FDA Warning Letter (2025-08-11) | | 2025-08-11 |
| Uscom Kft - FDA Warning Letter (2025-07-30) | | 2025-07-30 |
| Les Encres LLC - FDA Warning Letter (2025-07-30) | | 2025-07-30 |
| Spectra Therapy, LLC - FDA Warning Letter (2025-07-22) | | 2025-07-22 |
| Onkos Surgical, Inc. - FDA Warning Letter (2025-07-21) | | 2025-07-21 |
| LEVO AG - FDA Warning Letter (2025-07-18) | | 2025-07-18 |
| Leltek Inc. - FDA Warning Letter (2025-07-17) | | 2025-07-17 |
| WHOOP, Inc. - FDA Warning Letter (2025-07-14) | | 2025-07-14 |
| Jiangsu Kerbio Medical Technology Group Co. - FDA Warning Letter (2025-07-11) | | 2025-07-11 |
| Mectronic Medicale S.R.L. - FDA Warning Letter (2025-06-27) | | 2025-06-27 |
| CCIC Huatongwei International Inspection Co., Ltd. - FDA Warning Letter (2025-06-25) | | 2025-06-25 |
| Visgeneer, Inc - FDA Warning Letter (2025-06-13) | | 2025-06-13 |
| Reset Technology Corporation - FDA Warning Letter (2025-06-09) | | 2025-06-09 |
| Insightra Medical Inc. - FDA Warning Letter (2025-06-03) | | 2025-06-03 |
| Aju Pharm Co., Ltd. - FDA Warning Letter (2025-05-21) | | 2025-05-21 |
| Kabe Labortechnik GmbH - FDA Warning Letter (2025-05-09) | | 2025-05-09 |
| NeuroSync, Inc. - FDA Warning Letter (2025-05-09) | | 2025-05-09 |
| Microspecialties, LLC - FDA Warning Letter (2025-05-08) | | 2025-05-08 |
| DFI Co., Ltd. - FDA Warning Letter (2025-05-06) | | 2025-05-06 |
| Sedecal S.A. - FDA Warning Letter (2025-05-05) | | 2025-05-05 |
| Noah Medical Corporation - FDA Warning Letter (2025-04-09) | | 2025-04-09 |
| ICU Medical - FDA Warning Letter (2025-04-04) | | 2025-04-04 |
| DRG Instruments GmbH - FDA Warning Letter (2025-03-31) | | 2025-03-31 |
| United Health Products, Inc. - FDA Warning Letter (2025-03-24) | | 2025-03-24 |
| EpiCare Acquisitions, LLC - FDA Warning Letter (2025-03-21) | | 2025-03-21 |
| Rex Implants Inc. - FDA Warning Letter (2025-03-12) | | 2025-03-12 |
| Dexcom, Inc. - FDA Warning Letter (2025-03-04) | | 2025-03-04 |
| Next Science LLC - FDA Warning Letter (2025-02-21) | | 2025-02-21 |
| Red Oak Instruments, LLC - FDA Warning Letter (2025-02-21) | | 2025-02-21 |
| Exer Labs, Inc. - FDA Warning Letter (2025-02-10) | | 2025-02-10 |
| Q’Apel Medical, Inc. - FDA Warning Letter (2025-02-05) | | 2025-02-05 |
| Integra LifeSciences Corporation - FDA Warning Letter (2024-12-19) | | 2024-12-19 |
| Hologic, Inc. - FDA Warning Letter (2024-12-18) | | 2024-12-18 |
| Anne’s Daye Ltd dba Tampon Innovations - FDA Warning Letter (2024-12-17) | | 2024-12-17 |
| Xoran Technologies, LLC - FDA Warning Letter (2024-12-09) | | 2024-12-09 |
| Phillips Precision, Inc. - FDA Warning Letter (2024-12-09) | | 2024-12-09 |
| Randox Laboratories Limited - FDA Warning Letter (2024-12-06) | | 2024-12-06 |
| Becton, Dickinson, and Company/CareFusion 303, Inc. - FDA Warning Letter (2024-11-22) | | 2024-11-22 |
| Argon Medical Productions & Vertrieb Gesellschaft MBH & CO - FDA Warning Letter (2024-11-22) | | 2024-11-22 |
| Owens & Minor, Inc. dba American Contract Systems, Inc. - FDA Warning Letter (2024-11-01) | | 2024-11-01 |
| Rontis Hellas S.A. - FDA Warning Letter (2024-10-28) | | 2024-10-28 |
| Rolence Ent. Inc. - FDA Warning Letter (2024-10-18) | | 2024-10-18 |
| Adept Medical Ltd. - FDA Warning Letter (2024-10-11) | | 2024-10-11 |
| Micro-X Ltd. - FDA Warning Letter (2024-09-10) | | 2024-09-10 |
| Mid-Link Testing Company, Ltd - FDA Warning Letter (2024-09-10) | | 2024-09-10 |
| Sanitation & Environmental Technology Institute dba SDWH - FDA Warning Letter (2024-09-10) | | 2024-09-10 |
| Wissner-Bosserhoff GmbH - FDA Warning Letter (2024-08-30) | | 2024-08-30 |