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.
Bloomer Trailers is recalling 2006-2013 Evolution models equipped with Fastec door locks that may jam, potentially trapping occupants inside the trailer.
Siemens Healthcare Diagnostics is recalling 44 units of ADVIA Centaur Folate reagent due to calibration failures and significant negative shifts in quality control and patient results.
B. Braun Medical is recalling Outlook ES pumps because a software issue could cause the drug library to be lost, potentially leading to incorrect medication dosing.
B. Braun Medical Inc. is expanding a field correction for Outlook ES pumps where a specific key sequence can disable dose limit protection.
Berchtold Corp. is recalling 263 OPERON D850 surgical tables because they were not lowering. The units were distributed nationwide in the US and Canada.
University Compounding Pharmacy is voluntarily recalling Testosterone Cypionate/Testosterone Propionate Injection due to lack of assurance of sterility.
B. Braun Medical Inc. is recalling Outlook ES Safety Infusion Systems because the HOLD button may fail to function due to intermittent circuitry contact.
New Sun Inc is recalling Immune 101 dietary supplements due to positive E. coli test results. The voluntary recall affects 61,840 capsules distributed across 30 states.
Becton Dickinson is recalling BD Microtainer Quikheel Lancets because they may not retract after use, creating a risk of exposure to used sharps.
Spartan Motors is recalling 2011-2012 MM motorhomes with Cummins ISC engines because radiator fan blades may break without warning, posing an injury risk to people near the engine.
Park Compounding is recalling Methylcobalamin, Multitrace-5, and Testosterone Cypionate injections due to lack of sterility assurance.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.
Leica Microsystems is recalling five surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.
Spine Wave, Inc. is recalling 17 units of the StaXx IB Convex Expandable Implant because the superior endplate was manufactured from a different polymer than specified.
Sybron Dental Specialties is recalling 1,091 AOA Mini RPE Screw Assemblies because they may have incomplete welds. These components are used in orthodontic devices like Herbst and MARA appliances.
University Compounding Pharmacy is voluntarily recalling PGE-1, 20 mcg/mL Injection in Normal Saline due to lack of assurance of sterility.
Leica Microsystems is recalling 28 surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.
GE Healthcare is recalling Tec 6 and Tec 6 Plus anesthesia vaporizers because the pre-operative leak test may fail to detect leaks caused by seal wear.
University Compounding Pharmacy is voluntarily recalling PGE-1 injections due to lack of assurance of sterility. The recall affects nationwide distribution.
New Sun Inc. is voluntarily recalling JLB Combination dietary supplements due to positive E. coli test results.
FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water while labeled as saline or heparin.
Siemens Healthcare Diagnostics is recalling 488 units of ADVIA Centaur Folate reagent due to calibration failures and quality control shifts.
Xlumena is recalling 148 units of the NAVIX Access Device because a complaint investigation found the catheter can fracture at the distal end under load.
Roche Molecular Systems is recalling specific lots of cobas 4800 HPV test kits because a formulation error was identified during the manufacture of the Master Mix reagent.
CareFusion is recalling Thoracentesis and Safe-T Thoracentesis Trays because the included catheters may occlude, potentially delaying medical procedures and causing patient complications.