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.
Five Afinion 2 lab analyzers were distributed with incorrect configuration, potentially allowing waived laboratories to perform moderately complex assays that could produce erroneous results.
A software issue in DxI 9000 Access analyzers connected to laboratory automation systems may prevent processing of all samples, flagging tests as timed out and potentially delaying patient results.
Medline Industries is recalling Centurion procedure packs containing plastic syringes due to leaks, breakage, and quality defects that may pose a risk to patient health. The affected products are distributed worldwide.
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The recall affects 35 units with Part Number 584770 and is classified as FDA Class II.
Medline is recalling procedural kits with defective syringes due to leaks and breakage that may pose patient health risks. Affected products include biopsy packs, circumcision trays, and breast biopsy kits.
A custom-made orthopedic surgical implant was supplied for a surgical procedure that did not match the design specifications. This mismatch could affect the proper fit and function of the device during surgery.
Medline Industries is recalling multiple Centurion procedure kit models due to plastic syringe defects including leaks and breakage that may pose a risk to patient safety. The affected kits were distributed worldwide.
Stryker iBur 3.0mm Diamond Match Head surgical cutting tools may reach temperatures exceeding safe operating limits during bone surgery, potentially causing thermal tissue injury. About 2,507 units worldwide are affected.
Medline procedural kits contain plastic syringes with leaks and breakage that may pose health risks. The affected kits are used for delivery procedures and distributed worldwide.
Stryker iBur 4.0mm Diamond Round surgical burs may reach temperatures higher than specified, potentially causing thermal injury or tissue damage during bone-cutting procedures. Approximately 1,706 affected units have been distributed worldwide.
Medline is recalling medical procedure packs containing Shenli syringes due to identified leaks, breakage, and quality issues. These kits may pose a risk to patient health during surgical procedures.
Intuitive Surgical is recalling the Ion Endoluminal System due to potential screw failure in the instrument cart arm, which could cause uncontrolled catheter motion in patient airways.
Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.
Medline procedural kits contain plastic syringes with leaks, breakage, and quality issues that may pose patient health risks. Affected units have been distributed worldwide.
Medline is recalling three procedural kits containing plastic syringes with leaks and breakage issues that may pose a risk to patient health. The kits have been distributed worldwide.
Medline Industries is recalling Centurion procedure kits due to plastic syringes with defects including leaks and breakage. These defects may compromise patient safety during medical procedures.
Medline Industries is recalling Centurion procedure kits containing plastic syringes with leaks and breakage issues. The defective syringes may pose a risk to patient health during medical procedures.
Medline Industries is recalling Centurion procedure packs containing plastic syringes with identified leaks, breakage, and quality defects. The recall affects units distributed worldwide.
Stryker is recalling iBur 4.0mm Coarse Diamond surgical burs that may overheat during use. Excessive heat could cause tissue or bone damage requiring medical intervention.
Medline is recalling Preop Nerve Block Tray kits worldwide due to plastic syringes with leaks, breakage, and quality defects. These defects were identified in an FDA safety alert and may pose risks to patient health.
GE Healthcare's Proteus XR/a stationary X-ray system lacks a required de-installation manual, creating risk of personnel injury during device removal.
Medline is recalling two circumcision tray kit models due to plastic syringes with leaks, breakage, and quality defects that may harm patients. The kits have been distributed worldwide.
Medline Industries is recalling multiple procedural kits containing plastic syringes affected by an FDA Safety Alert. The syringes have quality issues including leaks and breakage that may pose a risk to patient health.
Medline has recalled Centurion procedure packs containing syringes due to leaks, breakage, and quality issues. These defects may pose a risk to patient health.
Treace Medical Concepts is recalling its Nanoplasty 3D Bunion Implant (Model SK57) nationwide due to potential mechanical failures where locking screws may strip or fail to seat properly. No injuries have been reported.