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 11 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list ICU Medical and its 14 subsidiaries with 999 device recalls, 343 510(k) clearances, 21 drug recalls, 14 drug applications and 2 warning letters. The most recent is a 510(k) clearance dated Sep 18, 2026: NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, ICU Medical and its 14 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 18, 2026 | NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)K262532 · LGZ | 510(k) clearances |
| Apr 2, 2026 | LifeShield Infusion Safety Software SuiteK252130 · PHC | 510(k) clearances |
| Mar 27, 2026 | OTTO™ Disinfecting CapK252006 · QBP | 510(k) clearances |
| Mar 20, 2026 | ClaveQS™ BagK251980 · KPE | 510(k) clearances |
| Jun 5, 2025 | Clave™ Neutral-Displacement Needlefree ConnectorsK250616 · FPA | 510(k) clearances |
| Apr 4, 2025 | Warning letter: MDR reporting, 510(k) requiredCDRH | Warning letters |
| Apr 2, 2025 | Plum Solo™ Precision IV PumpK242114 · FRN | 510(k) clearances |
| Apr 2, 2025 | LifeShield Infusion Safety Software SuiteK242117 · PHC | 510(k) clearances |
| Apr 2, 2025 | Plum Duo™ Precision IV PumpK242115 · FRN | 510(k) clearances |
| Feb 13, 2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USAClass I · Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible conta | Drug recalls |
| Feb 13, 2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, Class I · Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers wit | Drug recalls |
| Oct 1, 2021 | Warning letter: CAPA, Complaint handling, MDR reportingCDRH | Warning letters |
| Aug 16, 2013 | POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood Class II · Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled. | 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
