October 1, 2025Medical DevicesFDA
Biomet, Inc. recalls Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
Hazard: The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
October 1, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Hazard: The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
October 1, 2025Medical DevicesFDA
ORTOMA AB recalls Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019
Hazard: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
October 1, 2025Medical DevicesFDA
Biofire Defense recalls FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test in
Hazard: FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
October 1, 2025Medical DevicesFDA
CooperVision, Inc. recalls Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content,
Hazard: One lot manufactured with an invalid sterilization cycle.
October 1, 2025Medical DevicesFDA
CooperVision, Inc. recalls Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast mo
Hazard: One lot manufactured with an invalid sterilization cycle.
October 1, 2025Medical DevicesFDA
CooperVision, Inc. recalls MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Si
Hazard: One lot manufactured with an invalid sterilization cycle.
October 1, 2025Medical DevicesFDA
ETHICON, LLC recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/
Hazard: Potential for barb non-engagement.
October 1, 2025Medical DevicesFDA
Philips North America Llc recalls Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
Hazard: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
October 1, 2025Medical DevicesFDA
Philips North America Llc recalls Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
Hazard: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
October 1, 2025Medical DevicesFDA
Philips North America Llc recalls Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
Hazard: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
October 1, 2025Medical DevicesFDA
Philips North America Llc recalls Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
Hazard: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
October 1, 2025Medical DevicesFDA
Philips North America Llc recalls Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326
Hazard: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
October 1, 2025Medical DevicesFDA
Philips North America Llc recalls Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
Hazard: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
October 1, 2025Medical DevicesFDA
Philips North America Llc recalls Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Hazard: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
October 1, 2025Medical DevicesFDA
Philips North America Llc recalls Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Onco
Hazard: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
October 1, 2025Medical DevicesFDA
Philips North America Llc recalls Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Sl
Hazard: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
October 1, 2025Medical DevicesFDA
Philips North America Llc recalls Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT
Hazard: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
October 1, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8
Hazard: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
October 1, 2025Medical DevicesFDA
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Co
Hazard: Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
October 1, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POS
Hazard: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
October 1, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATI
Hazard: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
September 24, 2025Medical DevicesFDA
C.R. Bard Inc recalls SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
Hazard: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
September 24, 2025Medical DevicesFDA
C.R. Bard Inc recalls SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A
Hazard: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
September 24, 2025Medical DevicesFDA
C.R. Bard Inc recalls SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Hazard: Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
September 24, 2025Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Hazard: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
September 24, 2025Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Hazard: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
September 24, 2025Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Hazard: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
September 24, 2025Medical DevicesFDA
Abbott Point Of Care Inc. recalls i-STAT EG6+ cartridge. List Number: 03P77-25.
Hazard: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
September 24, 2025Medical DevicesFDA
Abbott Point Of Care Inc. recalls i-STAT EG7+ cartridge. List Number: 03P76-25.
Hazard: Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.