Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Amerisource Health Services is recalling 3,410 unit dose cartons of Prazosin Hydrochloride Capsules 5 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.
Fresenius Kabi is recalling six Ivenix Infusion System large volume pumps over a potential issue causing the device to register phantom touches in the lower-left corner of the touchscreen.
CareFusion is recalling 27 BD Pyxis Pro MedStation Main units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.
ICU Medical is recalling 600 Oncology Transfer Kits with ChemoClave and ChemoLock ports because the port weld of the drug transfer device may separate or break during use and leak.
Surgical Theater is recalling 45 units of its SuRgical Planner because a software anomaly may misalign secondary image layers against the primary layer.
ProRx is recalling 2,805 vials of Semaglutide Injection 5 mg/2 mL from one lot for lack of assurance of sterility.
Philips Medical Systems is recalling 105 Incisive CT scanners on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.
ICU Medical is recalling 133,255 ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 202,900 ChemosafeLock Vial Adapters because the port weld of the drug transfer device may separate or break during use and leak.
FarmaKeio Outsourcing is recalling 1,329 sterile Testosterone 25 mg pellets from one lot over the potential presence of metal particulate matter.
FarmaKeio Outsourcing is recalling 529 sterile Testosterone 87.5 mg pellets from one lot over the potential presence of metal particulate matter.
Heritage Pharmaceuticals is recalling 3,750 bottles of Desipramine Hydrochloride Tablets USP 150 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.
ICU Medical is recalling 200 60-inch smallbore extension sets with a ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
Aesculap is recalling 26 sealing units for 10/12mm trocars because silicone fragments may detach from the yellow sealing component.
ICU Medical is recalling 11,000 administration sets with a 20-drop integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.
Cepheid is recalling 4,132 Xpert SA Nasal Complete kits after post-market half-time stability testing produced a false negative result for a positive sample type.
ProRx is recalling 11,119 vials of Semaglutide Injection 8 mg/3.2 mL across four lots for lack of assurance of sterility.
Breckenridge Pharmaceutical is recalling 172,263 bottles of Duloxetine Delayed-Release Capsules 60 mg because N-nitroso-duloxetine was above the 12.5 ppm safety assessment limit.
ICU Medical is recalling 8,475 ChemoLock Closed Vial Spikes with Skirt because the port weld of the drug transfer device may separate or break during use and leak.
ICU Medical is recalling 2,000 ChemoLock Ports with Spiros and red cap because the port weld of the drug transfer device may separate or break during use and leak.
FarmaKeio Outsourcing is recalling 4,829 sterile Testosterone Regular Release 50 mg pellets from one lot over the potential presence of metal particulate matter.
ICU Medical is recalling 900 Syringe Transfer Sets with MicroClave and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.
FarmaKeio Outsourcing is recalling 103,444 sterile Testosterone / Triamcinolone Acetonide 100MG/20MCG pellets over the potential presence of metal particulate matter.
ICU Medical is recalling 80 units of ChemoLock Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.
Samsung Bioepis is recalling 5,518 cartons, 11,036 prefilled syringes, of HADLIMA (adalimumab-bwwd) injection 40mg/0.8 mL from one lot for lack of assurance of sterility.