Medicine · EMS · Public health · Awareness
8 = always on
Mepa8 is a free, independent daily news site covering medicine, EMS and public health in the United States and worldwide, founded October 13, 2026 in Sacramento, California by Ryan Bolden, an EMS professional. Every story links its primary sources.
Drugs & FDA
A U.S. Navy officer demonstrating how to operate an IV pump aboard a hospital ship in the Indian Ocean. Photo: U.S. Navy photo by Photographer's Mate 3rd Class Rebecca J. Moat (public domain)
The Nov. 6 announcement says no dose has been proven safe for patients with complete DPD deficiency and that data are insufficient to set a dose for partial deficiency.
Seven people fell ill and three died aboard a ship that sailed from Argentina, and 18 U.S. resident passengers were flown to the National Quarantine Unit in Omaha, where none developed infection.
The pooled review of 1164 participants also found no difference in rescue analgesia or in overall, serious, respiratory or hypotensive adverse events.
The approval rests on a 42% response rate among 102 patients in the open-label OrigAMI-4 trial, and the FDA has required confirmatory studies to verify clinical benefit.
What changed in medicine, public health and EMS overnight, before your shift starts. Add alerts for recalls the day the FDA posts them.
Recalls, protocols, research and the data behind the job, written for the people who run the calls.
The pooled review of 1164 participants also found no difference in rescue analgesia or in overall, serious, respiratory or hypotensive adver
avalanche rescue helicopAcross 25 runs on a simulated 80-by-150-meter slope, the hoist method put the paramedic on the ground 124 seconds sooner, but no real victim
prehospital analgesia trApart from one opioid study, none of the seventeen included studies reported a serious adverse event attributed to the drug, though minor ef
Photo: William B. Grice / CC BY-SA 4.0, converted to black and white
| FDA report | Class | Product | Why | Quantity |
|---|---|---|---|---|
| Oct 28 | II | Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M0011952 (Boston Scientific Cork, Ltd.) | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the oute | 42 |
| Oct 28 | II | Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M0011954 (Boston Scientific Cork, Ltd.) | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the oute | 620 |
| Oct 28 | II | Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M0011957 (Boston Scientific Cork, Ltd.) | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the oute | 432 |
| Oct 28 | II | Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent G (Life Technologies Holdings Pte Ltd) | DNA or RNA sequencing system software has vulnerabilities. | 16 |
| Oct 28 | II | Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280 (Boston Scientific Cork, Ltd.) | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the oute | 381 |
| Oct 28 | I | VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory (Ventec Life Systems, Inc.) | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resultin | 100 units |
| Oct 28 | II | Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly (Medtronic Navigation, Inc.) | Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect t | 3746 units |
| Oct 28 | II | MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYN (Medline Industries, LP) | Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patien | 56 kits |
| Oct 28 | I | V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. use (Ventec Life Systems, Inc.) | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resultin | 30,120 units |
Class I is the most serious: a reasonable chance of serious harm or death. Dates are when the FDA posted each recall to its enforcement report, not when the company started it. Data: openFDA, refreshed with each newsroom run.
Mepa8 is a free, independent daily news site covering medicine, EMS and public health in the United States and worldwide. It was founded on October 13, 2026 in Sacramento, California by Ryan Bolden, an EMS professional. Every story links the primary records it was written from.
Stories bylined Mepa8 Newsroom are drafted with AI from primary records such as FDA, CDC and WHO documents and peer-reviewed journals, then pass a verification program that checks every number, quote and link before publication. Ryan Bolden is the editor of record and handles corrections. Stories bylined by a person were written by that person.
No. Mepa8 reports news. It does not give medical advice. EMS clinicians follow their local protocols and medical direction. In an emergency, call 911.
Use the contact form at mepa8.com/contact. Corrections are dated, noted on the story and listed on the corrections page at mepa8.com/corrections.