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.
Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.
Duloxetine Delayed-Release Capsules USP 20 mg are being recalled nationwide due to presence of nitrosamine impurity above FDA acceptable limits. No adverse events have been reported.
Zimmer, Inc. is recalling NexGen LCCK knee implant articular surface components due to incorrect assembly of the metal support post. The defect was identified internally in a small number of units.
The FDA is recalling approximately 33,589 BD Pyxis MedStation automated dispensing cabinets due to door latch assembly failures that may leave doors open, potentially delaying medication access and enabling medication diversion.
LivaNova is recalling approximately 8,223 SenTiva VNS Therapy generators due to a potential internal component failure that may cause the implanted device to stop delivering seizure therapy. Affected patients should contact their physician.
Karl Storz is recalling 185 Pediatric Cysto-Urethroscope instruments nationwide. The product instructions contain reprocessing methods that have not been reviewed or approved by the FDA for safety and effectiveness.
The muRata Vios Monitoring System Model 2050 bedside cardiac monitor has been recalled due to a software issue causing patient vital signs and ECG waveforms to flicker and become distorted on the Central Station Monitor. No injuries have been reported.
The HOT AXIOS Stent delivery system's outer sheath tip may detach during use, preventing proper stent expansion and requiring device exchange. Boston Scientific is recalling 1,102 units distributed nationwide.
Boston Scientific recalls 1,399 units of AXIOS stent delivery systems due to outer sheath detachment that can prevent proper device expansion, requiring procedure prolongation and device exchange.
Karl Storz Ureteroscope model 27000K is being recalled due to instructions for use containing reprocessing modalities not reviewed or approved by the FDA. The recall affects 82 units distributed nationwide.
Kia is recalling certain 2024 EV9 vehicles because the front passenger seat belt retractor cover may not be properly secured, which can prevent the seat belt from locking correctly during a crash.
The AXIOS Stent and Delivery System is being recalled because the outer sheath can detach and prevent proper stent expansion, requiring device replacement during the procedure.
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
Medline's CENTURION infusion catheters in certain lots lack the antimicrobial heparin coating they are labeled as having. The mislabeled catheters were distributed to healthcare facilities in eight states.
LuLu Chinese Express Sweet and Sour Shrimp with Fried Rice is being recalled because soy allergen information is missing from the label. Consumers with soy allergies face a serious health risk.
Karl Storz Endoskope Uretero-Renoscope (Model 27011L) is recalled due to Instructions for Use containing reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 5 units distributed nationwide.
Karl Storz is recalling its Ureteroscope (Model 27001K) because the Instructions for Use contain reprocessing procedures that have not been reviewed or approved by the FDA. All 185 units distributed nationwide are affected.
B. Braun Medical is recalling 1,090 units of the Design Options Combined Spinal/Epidural Tray due to an incorrect catheter connector that cannot securely connect to the epidural catheter, preventing medication administration.
Karl Storz Endoscopy is recalling its Pediatric Uretero-Renoscope 7.3 Fr. due to unapproved reprocessing instructions. The device instructions contain procedures not reviewed or approved by the FDA for safety and efficacy.
Medtronic is recalling sterile percutaneous reference pins used in image-guided surgery because the pins may not fit into the patient reference frame or adapter, potentially affecting proper surgical tracking.
Siemens ARTIS One X-ray systems may deliver higher radiation doses during first imaging after patient registration due to copper prefiltration malfunction occurring in very rare situations.
Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.
Boston Scientific's HOT AXIOS Stent has a reported defect where the outer sheath distal black tip can detach, preventing proper stent expansion and requiring device exchange.
Karl Storz ureteroscopes contain reprocessing instructions that have not been reviewed and approved by the FDA. Affected devices should not be reprocessed using unapproved methods.
Ford is recalling certain 2020-2023 Escape, 2022-2023 Maverick, and 2021-2023 Corsair vehicles due to a 2.5L engine defect that could cause an engine compartment fire. No injuries have been reported.