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
Karl Storz Endoscopy is recalling 59 units of its uretero-renoscope due to instructions for use containing reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
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.
Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.
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.
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's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, requiring device replacement.
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.
LivaNova's SenTiva DUO vagus nerve stimulation device may stop delivering therapy due to an internal component issue. The recall affects 84 units distributed worldwide.
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.
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.
Karl Storz is recalling a uretero-renoscope surgical device (REF 27003L) because the reprocessing instructions in the product documentation have not been reviewed or approved by the FDA.
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.
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.
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.
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.
Karl Storz ureteroscopes are being recalled because their instructions contain reprocessing procedures that have not been reviewed or approved by the FDA. The recall affects 3,069 units distributed nationwide.
Boston Scientific is recalling 38 units of AXIOS Stent and Delivery System (15mmx10mm) because the outer sheath's distal tip may detach, preventing proper stent expansion and requiring device replacement.
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.
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.
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.
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.
Percussionaire Corporation is recalling VDR4 Phasitron breathing circuit models due to a venturi component that may stick and reduce ventilation. This Class I recall affects over 4,700 units worldwide.
Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (lot #600018) due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.
Microvention is recalling Lot #0000629846 of the Headway 17 Advanced Straight Microcatheter due to incomplete seals in inner packaging that could compromise sterility. The affected lot was distributed outside the U.S.