FDA Medical Device Recalls
Latest medical device recalls, corrections, and removals from FDA. Stay informed about safety issues affecting medical devices.
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT…
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open…
View FDA Recall →Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, …
Kits contain a potentially contaminated component which were recalled by the manufacturer
View FDA Recall →5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may …
View FDA Recall →Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ing…
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the perform…
View FDA Recall →Velys Enabling Tech Robotic-Assist Station REF: 451611001
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
View FDA Recall →POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Elec…
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
View FDA Recall →GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for B…
Complaints of blue-green discoloration in product
View FDA Recall →Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A15…
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter…
View FDA Recall →Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog Number: DYK…
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wri…
View FDA Recall →Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the …
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