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  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 961–980 of 1,000 recalls

Class IIOngoing

Allura Xper FD20/20; Model Number: 722038;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025 · DeviceView details →
Class IIOngoing

Allura Xper FD10/10; Model Number: 722005;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025 · DeviceView details →
Class IIOngoing

Allura Xper FD20; Model Number: 722012;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025 · DeviceView details →
Class IIOngoing

Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.

Diagnostica Stago, Inc.

Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

December 15, 2025 · DeviceView details →
Class IIOngoing

Allura Xper FD20/10; Model Number: 722029;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025 · DeviceView details →
Class IIOngoing

ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

ICU Medical, Inc.

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

December 15, 2025 · DeviceView details →
Class IOngoing

Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS 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 IIOngoing

Allura Xper FD10; Model Number: 722010;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025 · DeviceView details →
Class IIOngoing

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17

Sysmex America, Inc.

Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

December 15, 2025 · DeviceView details →
Class IIOngoing

Allura Xper FD20 Biplane; Model Number: 722008;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025 · DeviceView details →
Class IOngoing

Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS 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 IIOngoing

Plum Duo Infusion System, List Number 40002-04-01

ICU Medical, Inc.

ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.

December 15, 2025 · DeviceView details →
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 IIOngoing

Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

Hologic, Inc

Presence of particulates in affected devices that can be deposited into breast tissue during use.

December 15, 2025 · DeviceView details →
Class IIOngoing

Allura Xper FD20 OR Table; Model Number: 722023;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025 · DeviceView details →
Class IIOngoing

Allura Xper FD20 Biplane; Model Number: 722013;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025 · DeviceView details →
Class IIOngoing

Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10

Wilson-Cook Medical Inc.

Nasal feeding tube packaged without the nasal transfer tube component.

December 15, 2025 · DeviceView details →
Class IIOngoing

Allura Xper FD10; Model Number: 722026;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025 · DeviceView details →
Class IIOngoing

Allura Xper FD20; Model Number: 722006;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

December 15, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No

Elekta, Inc.

Due to a manufacturing issue and electrical grounding of systems.

December 14, 2025 · DeviceView details →
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