Civic Data
FDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

Browse

  • All recalls

About

  • About us
  • Guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API

© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA sources before acting

  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 121–140 of 328 recalls

Class IOngoing

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

SunMed Holdings, LLC

Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

December 15, 2025 · DeviceView details →
Class IOngoing

MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L

Medline Industries, LP

Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.

November 26, 2025 · DeviceView details →
Class IOngoing

MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO

Medline Industries, LP

Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.

November 26, 2025 · DeviceView details →
Class IOngoing

MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.

Medline Industries, LP

Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.

November 26, 2025 · DeviceView details →
Class IOngoing

MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO

Medline Industries, LP

Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.

November 26, 2025 · DeviceView details →
Class IOngoing

MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L

Medline Industries, LP

Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.

November 26, 2025 · DeviceView details →
Class IOngoing

MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pack,REF MDR107002E-4

Medline Industries, LP

Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.

November 26, 2025 · DeviceView details →
Class IOngoing

Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

Draeger, Inc.

A certain component of affected devices was not delivered within specification and contained impurities.

November 24, 2025 · DeviceView details →
Class IOngoing

FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Abbott Diabetes Care, Inc.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

November 24, 2025 · DeviceView details →
Class IOngoing

FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Abbott Diabetes Care, Inc.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

November 24, 2025 · DeviceView details →
Class IOngoing

Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

Alcon Research LLC

Ophthalmic procedure packs may have incomplete seals affecting sterility.

November 24, 2025 · DeviceView details →
Class IOngoing

Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.

Draeger, Inc.

A certain component of affected devices was not delivered within specification and contained impurities.

November 24, 2025 · DeviceView details →
Class IOngoing

FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Abbott Diabetes Care, Inc.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

November 24, 2025 · DeviceView details →
Class IOngoing

FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Abbott Diabetes Care, Inc.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

November 24, 2025 · DeviceView details →
Class IOngoing

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; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543

GE Medical Systems China Co., Ltd.

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.

November 14, 2025 · DeviceView details →
Class IOngoing

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

Fresenius Kabi USA, LLC

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

November 14, 2025 · DeviceView details →
Class IOngoing

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; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002

GE Medical Systems China Co., Ltd.

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.

November 14, 2025 · DeviceView details →
Class IOngoing

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

GE Medical Systems China Co., Ltd.

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.

November 14, 2025 · DeviceView details →
Class IOngoing

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

AVID Medical, Inc.

Devices are not suitable for organ transplant.

November 11, 2025 · DeviceView details →
Class IOngoing

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

AVID Medical, Inc.

Devices are not suitable for organ transplant.

November 11, 2025 · DeviceView details →
← PreviousPage 7 of 17Next →