# FDA warning letters on medical devices: 92 since Nov 2024

Updated October 7, 2026.

FDA issued 92 warning letters on medical devices from November 22, 2024 to October 7, 2026, to 92 companies; 5 have a closeout letter. The newest, issued October 7, 2026 by the Center for Devices and Radiological Health, went to Olympus Medical Systems Corporation (CGMP/QSR/Medical Devices/Adulterated).

## The full list

FDA warning letters: medical devices: 92 rows for $5, FDA warning letters issued November 12, 2024 to October 30, 2026. Columns: Company, Issue date, Posted, Issuing office, Subject, Subject group, Response letter posted, Closeout letter posted, Read on, Source. The new rows each week by email, about 3 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (issue date, subject group, response letter posted, closeout letter posted and read on), which open on your screen as soon as the payment clears and come by email.

Buy: https://specstream.ai/data/fda-warning-letters/subject/medical-devices

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- Letters: 92
- With closeout: 5
- Latest issued: October 7, 2026

## Newest letters

The newest 92 of 92 by issue date, each linked to the letter on fda.gov.

| Issued | Company | Issuing office | Subject | Posted | Source |
| --- | --- | --- | --- | --- | --- |
| October 7, 2026 | Olympus Medical Systems Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/olympus-medical-systems-corporation-729208-10072026) |
| October 6, 2026 | Tides Medical LLC | Center for Biologics Evaluation and Research | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tides-medical-llc-727246-10062026) |
| October 5, 2026 | Pro-Optics, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pro-optics-llc-734689-10052026) |
| October 2, 2026 | Chirp Innovations, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chirp-innovations-llc-731847-10022026) |
| September 22, 2026 | Unilam Co., LTD | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/unilam-co-ltd-738562-09222026) |
| September 1, 2026 | O.N. Diagnostics, LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/diagnostics-llc-730301-09012026) |
| August 26, 2026 | Peter Schiff Enterprises | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peter-schiff-enterprises-727888-08262026) |
| August 25, 2026 | Advance-Esthetic LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | September 22, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advance-esthetic-llc-729267-08252026) |
| August 21, 2026 | Lion Street Medical, d/b/a Pensar Medical LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | September 22, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lion-street-medical-dba-pensar-medical-llc-733015-08212026) |
| August 19, 2026 | Next Medical Products Company, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/next-medical-products-company-llc-727918-08192026) |
| July 24, 2026 | Nipro Renal Solutions USA, Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nipro-renal-solutions-usa-corporation-732874-07242026) |
| July 21, 2026 | Koven Technologies, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | August 4, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/koven-technologies-inc-734643-07212026) |
| July 7, 2026 | Specialty Health Products CO, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | September 22, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/specialty-health-products-co-llc-726564-07072026) |
| June 15, 2026 | Happiest Baby, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | June 15, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/happiest-baby-inc-718306-06152026) |
| June 12, 2026 | Nihon Kohden Digital Health Solutions, LLC | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | July 14, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nihon-kohden-digital-health-solutions-llc-727803-06122026) |
| June 4, 2026 | AseptiKits, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | June 30, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aseptikits-llc-728184-06042026) |
| June 3, 2026 | BlephEx, LLC | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blephex-llc-725861-06032026) |
| May 27, 2026 | Linemaster Switch Corporation | Center for Devices and Radiological Health | CGMP/QSR/Drug/Medical Devices/Adulterated | July 22, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/linemaster-switch-corporation-730215-05272026) |
| May 22, 2026 | ZIIP, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | July 14, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ziip-inc-725870-05222026) |
| May 20, 2026 | BMC Medical Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | June 30, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bmc-medical-co-ltd-725759-05202026) |
| May 20, 2026 | 3B Medical, Inc. dba Reach Health, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | June 30, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/3b-medical-inc-dba-reach-health-inc-725108-05202026) |
| May 19, 2026 | Skytron, LLC | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/skytron-llc-723950-05192026) |
| April 30, 2026 | ZOLL Medical Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | June 16, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zoll-medical-corporation-711320-04302026) |
| April 22, 2026 | Estar Technologies Ltd | Center for Biologics Evaluation and Research | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | May 12, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/estar-technologies-ltd-716831-04222026) |
| March 25, 2026 | Medline Industries, LP | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | April 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medline-industries-lp-723866-03252026) |
| February 26, 2026 | Longhorn Vaccines and Diagnostics LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | March 24, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/longhorn-vaccines-and-diagnostics-llc-721702-02262026) |
| February 24, 2026 | IsoTis OrthoBiologics, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | March 24, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/isotis-orthobiologics-inc-723370-02242026) |
| February 10, 2026 | ProDx Health | Center for Biologics Evaluation and Research | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | February 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prodx-health-720762-02102026) |
| February 6, 2026 | ExThera Medical Corporation | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | February 24, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/exthera-medical-corporation-715068-02062026) |
| January 29, 2026 | Diasol, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | March 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/diasol-inc-719460-01292026) |
| January 28, 2026 | Beta Bionics, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | February 24, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/beta-bionics-inc-717927-01282026) |
| January 27, 2026 | Flextronics America LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | February 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flextronics-america-llc-722180-01272026) |
| January 23, 2026 | Abbott Diabetes Care, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | February 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abbott-diabetes-care-inc-722046-01232026) |
| January 9, 2026 | Germaphobix | Center for Biologics Evaluation and Research | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | January 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/germaphobix-720555-01092026) |
| January 8, 2026 | Unomedical Device S.A. de C.V. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | February 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/unomedical-device-sa-de-cv-719428-01082026) |
| January 8, 2026 | Genovate | Center for Biologics Evaluation and Research | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | January 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genovate-720554-01082026) |
| January 8, 2026 | Genetrace | Center for Biologics Evaluation and Research | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | January 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genetrace-720529-01082026) |
| December 22, 2025 | Meridian Bioscience, Inc | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | January 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/meridian-bioscience-inc-720826-12222025) |
| December 19, 2025 | Exactech, Inc. dba Advita Ortho | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | March 10, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/exactech-inc-dba-advita-ortho-720250-12192025) |
| December 17, 2025 | MAST Biosurgery USA, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | January 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mast-biosurgery-usa-inc-720661-12172025) |
| December 9, 2025 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | January 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/asp-global-llc-dba-anatomy-supply-partners-llc-718444-12092025) |
| November 12, 2025 | Physitemp Instruments, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | March 31, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/physitemp-instruments-llc-717394-11122025) |
| November 11, 2025 | Envoy Medical Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | December 9, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/envoy-medical-inc-718762-11112025) |
| October 28, 2025 | Hong Qiangxing Shenzhen Electronics Limited | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | November 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hong-qiangxing-shenzhen-electronics-limited-718112-10282025) |
| October 3, 2025 | Qianjiang Kingphar Medical Material Co Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | October 28, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/qianjiang-kingphar-medical-material-co-ltd-716715-10032025) |
| October 2, 2025 | Contec Medical Systems Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | October 28, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/contec-medical-systems-co-ltd-717941-10022025) |
| September 26, 2025 | Technological Medical Advancements LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | October 7, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/technological-medical-advancements-llc-712715-09262025) |
| September 23, 2025 | Insung Medical Co. Ltd. | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | September 30, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/insung-medical-co-ltd-712545-09232025) |
| September 18, 2025 | LifeVac, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | October 14, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lifevac-llc-713455-09182025) |
| September 9, 2025 | Royal Philips | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | October 28, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-philips-709948-09092025) |
| September 3, 2025 | Avertix Medical, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | March 17, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/avertix-medical-inc-711080-09032025) |
| August 25, 2025 | The Richline Group, Inc. | Center for Devices and Radiological Health | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | September 23, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/richline-group-inc-712818-08252025) |
| August 21, 2025 | SeniorLife Technologies, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | September 16, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/seniorlife-technologies-inc-707021-08212025) |
| August 19, 2025 | Miach Orthopaedics | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | August 26, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/miach-orthopaedics-709827-08192025) |
| August 11, 2025 | LeMaitre Vascular, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | August 26, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lemaitre-vascular-inc-713502-08112025) |
| July 30, 2025 | Uscom Kft | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | August 26, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/uscom-kft-708491-07302025) |
| July 30, 2025 | Les Encres LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | August 19, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/les-encres-llc-709263-07302025) |
| July 22, 2025 | Spectra Therapy, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | August 12, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/spectra-therapy-llc-698026-07222025) |
| July 21, 2025 | Onkos Surgical, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | July 29, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/onkos-surgical-inc-712573-07212025) |
| July 18, 2025 | LEVO AG | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | October 21, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/levo-ag-717287-07182025) |
| July 17, 2025 | Leltek Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | July 22, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/leltek-inc-710787-07172025) |
| July 14, 2025 | WHOOP, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | July 15, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025) |
| July 7, 2025 | O3UV, LLC | Center for Biologics Evaluation and Research | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | July 22, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025) |
| June 27, 2025 | Mectronic Medicale S.R.L. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | August 5, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mectronic-medicale-srl-707997-06272025) |
| June 13, 2025 | Visgeneer, Inc | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | August 5, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/visgeneer-inc-709010-06132025) |
| June 9, 2025 | Reset Technology Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | June 17, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/reset-technology-corporation-704828-06092025) |
| June 3, 2025 | Insightra Medical Inc. | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | July 8, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/insightra-medical-inc-706921-06032025) |
| May 21, 2025 | Aju Pharm Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | June 24, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aju-pharm-co-ltd-704823-05212025) |
| May 9, 2025 | Kabe Labortechnik GmbH | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | May 21, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kabe-labortechnik-gmbh-704563-05092025) |
| May 9, 2025 | NeuroSync, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | May 20, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/neurosync-inc-705489-05092025) |
| May 8, 2025 | Microspecialties, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | May 20, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/microspecialties-llc-707614-05082025) |
| May 6, 2025 | DFI Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | June 3, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dfi-co-ltd-705464-05062025) |
| May 5, 2025 | Sedecal S.A. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | May 27, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sedecal-sa-707156-05052025) |
| April 9, 2025 | Noah Medical Corporation | Center for Devices and Radiological Health | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | April 22, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/noah-medical-corporation-702414-04092025) |
| April 4, 2025 | ICU Medical | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | April 22, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/icu-medical-702535-04042025) |
| March 31, 2025 | DRG Instruments GmbH | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | May 27, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/drg-instruments-gmbh-700918-03312025) |
| March 21, 2025 | EpiCare Acquisitions, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | April 8, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/epicare-acquisitions-llc-702493-03212025) |
| March 12, 2025 | Rex Implants Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | March 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rex-implants-inc-676429-03122025) |
| March 4, 2025 | Dexcom, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | March 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dexcom-inc-700835-03042025) |
| February 21, 2025 | Next Science LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | April 1, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/next-science-llc-698114-02212025) |
| February 21, 2025 | Red Oak Instruments, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | March 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/red-oak-instruments-llc-692368-02212025) |
| February 10, 2025 | Exer Labs, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | March 25, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/exer-labs-inc-699218-02102025) |
| February 5, 2025 | Q’Apel Medical, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | March 11, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/qapel-medical-inc-699244-02052025) |
| January 21, 2025 | Robbins Instruments, LLC | ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality | Medical Device/Misbranded/Unapproved Device/Quality System Regulation | February 18, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/robbins-instruments-llc-687984-01212025) |
| December 19, 2024 | Integra LifeSciences Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | January 14, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/integra-lifesciences-corporation-698850-12192024) |
| December 18, 2024 | Hologic, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | January 14, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hologic-inc-698214-12182024) |
| December 17, 2024 | Anne’s Daye Ltd dba Tampon Innovations | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | December 24, 2024 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/annes-daye-ltd-dba-tampon-innovations-696362-12172024) |
| December 9, 2024 | Xoran Technologies, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | January 14, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xoran-technologies-llc-694229-12092024) |
| December 9, 2024 | Phillips Precision, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | January 14, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/phillips-precision-inc-697119-12092024) |
| December 6, 2024 | Randox Laboratories Limited | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | January 14, 2025 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/randox-laboratories-limited-696569-12062024) |
| November 22, 2024 | Becton, Dickinson, and Company/CareFusion 303, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | December 17, 2024 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/becton-dickinson-and-companycarefusion-303-inc-691601-11222024) |
| November 22, 2024 | Argon Medical Productions & Vertrieb Gesellschaft MBH & CO | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | October 29, 2024 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/argon-medical-productions-vertrieb-gesellschaft-mbh-co-694763-11222024) |

## Subjects as FDA words them

| Subject | Letters | Latest |
| --- | --- | --- |
| CGMP/QSR/Medical Devices/Adulterated | 47 | October 7, 2026 |
| Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | 13 | August 25, 2026 |
| Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | 10 | October 6, 2026 |
| CGMP/QSR/Medical Devices/Adulterated/Misbranded | 7 | October 3, 2025 |
| Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | 5 | August 26, 2026 |
| Medical Device Reporting/Misbranded | 4 | September 1, 2026 |
| CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | 3 | May 20, 2026 |
| CGMP/QSR/Drug/Medical Devices/Adulterated | 1 | May 27, 2026 |
| CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated | 1 | April 9, 2025 |
| Medical Device/Misbranded/Unapproved Device/Quality System Regulation | 1 | January 21, 2025 |

## By issuing office

| Issuing office | Letters | Latest |
| --- | --- | --- |
| [Center for Devices and Radiological Health](https://specstream.ai/data/fda-warning-letters/office/center-for-devices-and-radiological-health) | 84 | October 7, 2026 |
| [Center for Biologics Evaluation and Research](https://specstream.ai/data/fda-warning-letters/office/center-for-biologics-evaluation-and-research) | 7 | October 6, 2026 |
| ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality | 1 | January 21, 2025 |

## By year issued

| Year | Letters | Latest |
| --- | --- | --- |
| [2025](https://specstream.ai/data/fda-warning-letters/year/2025) | 47 | December 22, 2025 |
| [2026](https://specstream.ai/data/fda-warning-letters/year/2026) | 37 | October 7, 2026 |
| [2024](https://specstream.ai/data/fda-warning-letters/year/2024) | 8 | December 19, 2024 |

## Where FDA publishes its warning letters

- [FDA warning letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

Source: [FDA warning letters (U.S. Food and Drug Administration)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters). Public domain (U.S. government work). Letters are as FDA lists them in its warning letters table: the company, the issue and posting dates, the issuing office and FDA's subject line. Subject groups are SpecStream's, read from the words of that subject line. FDA posts a letter some weeks after it issues it, so the newest weeks fill in later.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).