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., part of ICU MedicalLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Smiths Medical ASD with 293 device recalls, 52 510(k) clearances and 1 warning letter. The most recent is a warning letter dated Apr 4, 2025: Warning letter: MDR reporting, 510(k) required.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 4, 2025 | Warning letter: MDR reporting, 510(k) requiredCDRH | Warning letters |
| May 31, 2024 | Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeK232943 · QNQ | 510(k) clearances |
| Nov 10, 2023 | 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694RClass II · There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devic | Device recalls |
| Nov 10, 2023 | Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682RClass II · There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devic | Device recalls |
| Nov 10, 2023 | 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRLClass II · There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devic | Device recalls |
| Nov 10, 2023 | HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HPClass II · There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devic | Device recalls |
| Nov 10, 2023 | HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HPClass II · There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devic | Device recalls |
| Nov 10, 2023 | 6IN PRESSURE TUBING, List Number MX20617Class II · There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devic | Device recalls |
| Nov 10, 2023 | Medex LOGICAL CATH LAB KIT, List Number M20754Class II · There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devic | Device recalls |
| Nov 10, 2023 | 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BRClass II · There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devic | Device recalls |
| Nov 26, 2021 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner CannulaK210833 · JOH | 510(k) clearances |
| Oct 1, 2021 | Warning letter: CAPA, Complaint handling, MDR reportingCDRH | Warning letters |
| Aug 26, 2021 | Hypodermic Needle-Pro EDGE Safety DeviceK211634 · FMI | 510(k) clearances |
| Sep 18, 2020 | Intellifuse Administration and Intellifuse Blood Administration SetsK192375 · FPA | 510(k) clearances |
| Jul 26, 2018 | Level 1 Convective WarmerK181699 · DWJ | 510(k) clearances |
| Jun 14, 2018 | Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectorsK172800 · MIA | 510(k) clearances |
| Jun 12, 2018 | Portex NRFit Epidural NeedlesK172823 · BSP | 510(k) clearances |
| Jun 1, 2018 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio FiltersK172410 · BSP | 510(k) clearances |
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
