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Showing 4081–4100 of 5023 results

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ABL90 Series (Radiometer) – analyzer freeze risk (2025)

ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.

FDAMar 21, 2025AL, AZ, AR +46 more• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Green Series 777 Wall System (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

Mar 21, 2025

Nationwide

• Baxter Healthcare Corporation

CareStation 620 A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

FDAMar 21, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

Spot Vital Signs 4400 (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

CareStation 750 A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

FDAMar 21, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

International MV (International) – caliper suspension contact (2025)

International Motors, LLC (International) is recalling certain 2024 HV, 2020-2025 MV, and 2019 Workstar 7400 trucks. The caliper may contact a suspension spring or axle U-bolt and prevent the outer brake pad from functioning.

NHTSAMar 21, 2025Nationwide• INTERNATIONAL

Phasor Drill (Phasor Health) – battery orientation risk (2025)

Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

FDAMar 21, 2025AZ, AR, CA +25 more• Phasor Health, LLC

CareStation 650C A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

FDAMar 21, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

Methocarbamol Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

Venlafaxine Tablets (Zydus) – Foreign Material Risk (2025)

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

Class IIModerate

FDAMar 21, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Lack of Assurance of Sterility: Media fill with bacterial contamination

Class IIModerate

FDAMar 21, 2025Nationwide• Somerset Therapeutics Private Limited

CareStation 650 A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

FDAMar 21, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

Connex Vital Signs Monitor (Baxter) – undeclared rubber band (2025)

Undeclared Allergen

Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

FDAMar 21, 2025Nationwide• Baxter Healthcare Corporation

OEC Elite (GE Medical) – X-ray field distance issue (2025)

OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

FDAMar 21, 2025Nationwide• GE Medical Systems, LLC

CareStation 750c A1 (GE Healthcare) – ventilation ineffective (2025)

GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.

FDAMar 21, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

Fresh Flax Oil (Bioriginal) – undeclared soy (2025)

Undeclared Allergen

Undeclared allergens: Soy lecithin

Class IIModerate

FDAMar 21, 2025PR• Bioriginal Food & Science Corporation

Snowmobile Ski Kits (Kimpex) – crash risk (2025)

This recall involves Kimpex Rush and Kimpex Arrow II Ski Kits and Kimpex Rush and Kimpex Arrow II adaptor kits. The recalled kits are used to replace the skis on snowmobiles and were sold in red, green, yellow, white, black and blue. "Kimpex" is stamped on both sides of the snowmobile's ski handles.

CPSCMar 20, 2025Nationwide• Kimpex Inc., of Drummondville, Canada

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