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.
Minimum severity
Philips Achieva 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings when certain image reconstruction parameters are used together, potentially affecting diagnostic accuracy.
Heraeus Medical is recalling PALAMIX duo dental mixing units (Material Number 66057897) because the mixing rod may come loose from its lock during use in units older than 1.5 years. The shelf life is being reduced from 3 years to 1.5 years.
Heraeus Medical is recalling PALAMIX uno dental material because the mixing rod may come loose during mixing in units older than 1.5 years. The shelf life has been reduced from 3 years to 1.5 years.
Medline Industries is recalling 41 different surgical kit models nationwide because regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded. Affected facilities should stop use and contact Medline.
Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Medline Industries, LP is recalling Medline Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed worldwide.
Medline Industries is recalling multiple Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects products distributed worldwide including the US, Canada, Panama, and Barbados.
Medline Industries has recalled its PICC Tray (Model DYNJ41648A) because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded by FDA.
LSL Healthcare is recalling IV Start Kits containing Webcol Large Alcohol Prep Pads due to non-sterility concerns. The affected kits were distributed nationwide in Maryland, Illinois, and Minnesota.
Medline Industries has recalled six medical device kits (arthrogram trays, angiography packs, and neuro packs) because their 510(k) regulatory clearances have been rescinded by the FDA.
LSL Healthcare is recalling its Infant Central Line Dressing Change Kit (Model 2925H) distributed nationwide because it contains Webcol Large Alcohol Prep Pads that were recalled for non-sterility.
Medline Industries is recalling 12 types of angiography and catheter kits because their 510(k) regulatory clearances have been rescinded. The kits were distributed nationwide.
Medline Industries is recalling Convenience Kits containing 10mL polycarbonate colored syringes because the products were modified in ways not approved by the FDA. The kits were distributed nationwide and internationally.
Medline Industries is recalling multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.
Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The kits were distributed nationwide in the US and to Canada, Panama, and Barbados.
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects multiple product SKUs distributed nationwide and internationally.
Medline Industries has recalled Control Syringes (Model DNSC89369 and DYNJSYR10C), Guidewires, and High-Pressure Tubing after their FDA 510(k) regulatory clearances were rescinded. The devices were distributed nationwide.
Angiodynamics, Inc. is recalling Soft-Vu Angiographic Catheter (Straight Art, Non-Braided) units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.
Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes (Eye Pack and Heart Cath Pack) due to unapproved design changes made outside of FDA 510(k) clearance.
Medline Industries is recalling certain Labor Pack kits (Model DYNJ44813D) nationwide because their 510(k) regulatory clearances for Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.
Angiodynamics is recalling Soft-Vu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub's inner diameter.
Pending LLM rewrite. Source: FDA_DEVICE Z-1883-2026.
Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Pending LLM rewrite. Source: FDA_DEVICE Z-1852-2026.
Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kit units due to potential backflow of medication between IV containers and risk of priming failure in gravity and pump administration sets.