Medical Device Recalls

8,689 medical device recalls from federal enforcement feeds.

Showing 2,301–2,350 of 8,689

• Medical Device Recall · November 17, 2025

  Intuitive Surgical, Inc.

  Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.

  An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.

  Class II

• Medical Device Recall · November 17, 2025

  Sophysa

  The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

  Customer complaints of Pressio monitor rebooting.

  Class II

• Medical Device Recall · November 14, 2025

  GE Medical Systems China Co., Ltd.

  GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000

  Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

  Class I

• Medical Device Recall · November 14, 2025

  GE Medical Systems China Co., Ltd.

  GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200;

  Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

  Class I

• Medical Device Recall · November 14, 2025

  Olympus Corporation of the Americas

  Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy Sys

  Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

  Class II

• Medical Device Recall · November 14, 2025

  Fresenius Kabi USA, LLC

  Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

  Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

  Class I

• Medical Device Recall · November 14, 2025

  AVID Medical, Inc.

  Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.

  Potential for incomplete seal on header bag.

  Class II

• Medical Device Recall · November 14, 2025

  GE Medical Systems China Co., Ltd.

  GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S

  Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operate on battery power in a rare event that AC mains power is lost and there is no continuous backup emergency power. If AC power is interrupted, the system will not automatically switch over to the battery supply mode and will reboot. If this issue occurs, a temporary disruption of mechanical ventilation, manual ventilation, and volatile agent delivery may occur. Following the reboot, the system will not return to the previous ventilation settings.

  Class I

• Medical Device Recall · November 14, 2025

  AVID Medical, Inc.

  Halyard, EP LAB PK. Catalog Number: ESJH009-03.

  Potential for incomplete seal on header bag.

  Class II

• Medical Device Recall · November 14, 2025

  AVID Medical, Inc.

  Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.

  Potential for incomplete seal on header bag.

  Class II

• Medical Device Recall · November 14, 2025

  AVID Medical, Inc.

  Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.

  Potential for incomplete seal on header bag.

  Class II

• Medical Device Recall · November 14, 2025

  Olympus Corporation of the Americas

  Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an elec

  Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

  Class II

• Medical Device Recall · November 14, 2025

  AVID Medical, Inc.

  Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.

  Potential for incomplete seal on header bag.

  Class II

• Medical Device Recall · November 14, 2025

  Olympus Corporation of the Americas

  Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy Sys

  Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

  Class II

• Medical Device Recall · November 13, 2025

  Medtronic MiniMed, Inc.

  InPen App, Model/CFN Number: MMT-8061 (Android Users)

  When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.

  Class II

• Medical Device Recall · November 13, 2025

  Medline Industries, LP

  FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048

  The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

  Class II

• Medical Device Recall · November 13, 2025

  Medline Industries, LP

  SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000

  The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

  Class II

• Medical Device Recall · November 13, 2025

  Microbiologics Inc

  KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K

  Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

  Class II

• Medical Device Recall · November 13, 2025

  Abbott Laboratories

  Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

  Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

  Class II

• Medical Device Recall · November 12, 2025

  Cardinal Health 200, LLC

  ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Med

  Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

  Class II

• Medical Device Recall · November 12, 2025

  Howmedica Osteonics Corp.

  The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit fo

  When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.

  Class II

• Medical Device Recall · November 12, 2025

  Remel, Inc

  1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

  Products may contain contamination, which may result in a darker or brown media color.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Medline Industries, LP

  DEXLOCK Achilles Repair Implant Kits, MAKT4520

  There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  AVID Medical, Inc.

  Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08

  Devices are not suitable for organ transplant.

  Class I

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  AVID Medical, Inc.

  Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.

  Devices are not suitable for organ transplant.

  Class I

• Medical Device Recall · November 11, 2025

  AVID Medical, Inc.

  Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.

  Devices are not suitable for organ transplant.

  Class I

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 11, 2025

  Olympus Corporation of the Americas

  Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.

  Complaints of the ceramic tip of the resection sheath breaking have been received.

  Class II

• Medical Device Recall · November 10, 2025

  Waldemar Link GmbH & Co. KG (Mfg Site)

  Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.

  The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.

  Class II

• Medical Device Recall · November 10, 2025

  Draeger, Inc.

  ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a m

  Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

  Class I

• Medical Device Recall · November 10, 2025

  Beckman Coulter, Inc.

  COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all

  Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

  Class II

• Medical Device Recall · November 10, 2025

  Draeger, Inc.

  ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mecha

  Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

  Class I