Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Haemonetics and its 3 subsidiaries with 65 510(k) clearances and 31 device recalls. The most recent is a 510(k) clearance dated Jan 16, 2026: OptoMonitor 3.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Haemonetics and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 16, 2026 | OptoMonitor 3K251367 · DXO | 510(k) clearances |
| Apr 30, 2025 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeK251024 · JPA | 510(k) clearances |
| Feb 12, 2025 | OptoMonitor 3K241418 · DXO | 510(k) clearances |
| Jan 15, 2025 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeK243858 · JPA | 510(k) clearances |
| May 24, 2024 | PacePro WireK240864 · DQX | 510(k) clearances |
| Mar 29, 2024 | Citrated: K, KH, RTH, FFHK232018 · JPA | 510(k) clearances |
| Nov 15, 2022 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)K221722 · CAC | 510(k) clearances |
| Sep 14, 2022 | SavvyWireK213854 · DQX | 510(k) clearances |
| Apr 26, 2022 | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034Class II · Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. | Device recalls |
| Apr 19, 2022 | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMappClass II · When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Man | Device recalls |
| Feb 19, 2020 | TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulatiClass II · Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference | Device recalls |
| Oct 21, 2019 | JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or suClass II · Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl set | Device recalls |
| Oct 21, 2019 | CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the rClass II · Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl set | Device recalls |
| Oct 21, 2019 | JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing ofClass II · Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl set | Device recalls |
| Oct 21, 2019 | CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover Class II · Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl set | Device recalls |
| Oct 21, 2019 | Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing ofClass II · Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl set | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
