Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
Boston Scientific is recalling AXIOS Stent devices due to outer sheath distal tip detachment that can prevent proper stent expansion and require device replacement during the procedure.
Snap rings may detach from internal shafts in CyberKnife Treatment Delivery Systems, potentially causing uncontrolled rotation on treatment axes. This affects 212 units distributed worldwide for stereotactic radiosurgery.
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.
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.
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.
Boston Scientific's HOT AXIOS stent delivery system may have an outer sheath that detaches and prevents proper stent expansion. The defective tip can remain around the stent, requiring device exchange during the procedure.
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.
The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring device replacement during the procedure.
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.
Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.
Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.
Boston Scientific's AXIOS Stent Delivery System (47 units affected) is recalled because the outer sheath can detach and prevent proper stent expansion, requiring device exchange.
Medline Industries recalls certain Sterile Infusion Catheters labeled as having antimicrobial heparin coating but lacking this coating. Affected units were either distributed directly or incorporated into medical convenience kits.
Boston Scientific is recalling HOT AXIOS Stent systems due to potential outer sheath detachment that can prevent proper stent expansion. This defect may require device replacement during the procedure.
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.
Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.
Alphatec Spine is recalling Calibrate CCX spinal implants used in fusion procedures after receiving complaints of post-operative implant collapse. Approximately 1,511 implants were distributed nationwide.
Boston Scientific is recalling 1,144 AXIOS Stent Delivery System units because the outer sheath's distal black tip can detach. If this occurs, the tip may remain around the stent saddle and prevent proper stent expansion, requiring device exchange.
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 uretero-renoscope devices are being recalled because their instructions for reprocessing and sterilization have not been FDA-reviewed or approved. This poses a potential patient safety risk.
Zimmer, Inc. is recalling 155 units of NexGen LCCK Legacy knee implant components because the metal support post was assembled incorrectly in some units. The defective assembly could compromise implant function.
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.
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.
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.
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.