FDA Alerts and Recalls

What changed

FDA posted three new potentially high-risk device early alerts on August 21, 2026. Medline: all lots of listed Hudson RCI neonatal/infant heated-wire breathing circuits, with affected item families HUD78001KIT, HUD78007, HUD78007KIT, HUD78008KIT, HUD78009, HUD78009KIT, HUD78013, HUD78014, HUD78015, HUD78017KIT, HUD78018, HUD78018KIT, HUD78019, HUD88001KIT, HUD88013KIT, HUD88014KIT, HUD88015KIT and HUD88017KIT and corresponding Teleflex identifiers. The issue is connector discoloration, melting, smoke, burning odor or thermal damage, potentially causing loss of heated-wire function, cold/dry gas, condensation, airway injury or obstruction. Company letters were sent July 13, July 27 and August 5; FDA posted August 21. Geographic scope was affected U.S. customers; full distribution, expiration and serial scope were not reported. Status: Early Alert—FDA collecting information; no FDA recall class was assigned in the notice and the matter was not listed as terminated. This was company-initiated customer removal, posted by FDA, not described as FDA-mandated. No serious injuries or deaths were reported as of July 31; denominator not reported. Action: immediately identify and quarantine, complete response forms and destroy after recall actions. Regulatory basis: FDA CDRH postmarket early-alert authority. GE HealthCare: Portrait Core Services software V1.0.5, V1.1 and V1.2, reference numbers 5697353, 5700209, 5700592 and 5700225, UDIs 00195278364838, 00195278679284, 00198953056752 and 00195278679307. Hazard: patient removal from monitoring and reset alarm defaults during updates, with possible loss of monitoring or intended alarms. Company letter July 20; FDA posting August 21. Distribution, expiration and serial scope not reported. Status: Early Alert—FDA collecting information; no recall class assigned and not terminated. Company-initiated correction posted by FDA; not described as FDA-mandated. No serious injuries or deaths as of July 29; denominator not reported. Action: establish alternative monitoring before updates and retain the manual addendum. Medical Action Industries: epidural-kit models 82465, 59553 and 83945B; affected lots 329618, 330274, 331036, 332995, 347199, 330827, 330907, 333956, 337283, 350340, 333957, 338894, 350354, 351266, 373674 and 375449; UDIs 10809160367414, 10809160010518 and 10809160444269. Hazard: included Huons/Spectra sodium-chloride ampules may have compromised sterility, exposing patients to microorganisms, endotoxins or foreign matter and potentially causing infection, organ failure, paralysis or death. Company letter July 23; FDA posting August 21. Distribution and expiration scope not reported. Status: Early Alert—FDA collecting information; no recall class assigned in the alert and not terminated. Company-initiated correction posted by FDA; not described as FDA-mandated. No serious injuries or deaths as of July 23; denominator not reported. Action: quarantine kits, add warning labels, remove and discard sodium-chloride ampules; remaining components may be used. Regulatory basis: FDA CDRH postmarket early-alert authority and downstream component recall monitoring.

Why it matters

The products support neonatal ventilation, continuous patient monitoring and epidural procedures; failures could cause severe harm even though no serious injuries or deaths were reported in the notices.

What to watch next

FDA classification updates, Enforcement Report entries, expanded lot or model scopes, company effectiveness checks and any reported injuries.

What we know

• FDA posted three early alerts on August 21: Medline neonatal/infant heated-wire breathing circuits, GE HealthCare Portrait Core Services software and Medical Action Industries epidural kits.
• These are early alerts for potentially high-risk issues; they were not listed as completed or terminated recalls and FDA was collecting or reviewing information.
• Medline affected all lots of listed Hudson RCI circuits, including item-number families HUD78001KIT through HUD88017KIT and corresponding Teleflex identifiers; customers should quarantine and destroy affected product after recall actions.
• GE affected Portrait Core Services versions 1.0.5, 1.1 and 1.2, including reference numbers 5697353, 5700209, 5700592 and 5700225; alternative monitoring should be established before updates, but devices may remain in use under revised instructions. No serious injuries or deaths were reported as of July 29; denominator not reported and geographic distribution was not specified in the notice beyond affected U.S. customers. The action was company-initiated and FDA-posted while FDA reviewed information; no recall class was assigned in the alert and status was Early Alert—FDA collecting information. Company customer communication was July 20; FDA posting was August 21, 2026. The hazard is loss of monitoring or intended alarms when patients are removed during updates or alarm settings reset to defaults. Product identifiers include UDI 00195278679284, 00195278364838, 00198953056752 and 00195278679307. Expiration and serial numbers were not reported; distribution scope was not reported. This is not an FDA finding of injury causation or an FDA-mandated recall as presented in the notice. No confirmed serious injuries or deaths; denominator not reported. Clinicians should establish alternative monitoring before software updates and retain the manual addendum. Regulatory basis: FDA CDRH early-alert/postmarket device-safety authority while collecting information.

Material unknowns

• Final FDA recall classification and status.
• Total units distributed and exposed-patient denominators.
• Whether additional injuries are identified.
• Complete geographic and serial or expiration scope where absent.