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FDA Recalls
›Device Recalls

FDA Device Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 2401–2420 of 39,430 recalls

Class IIOngoing

ICU Medical ChemoLock Closed Vial Spike REF: CL-80

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ChemoLock Bag Spike, 01 units REF: CL-10-10

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70

ICU Medical, Inc.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

September 8, 2025 · DeviceView details →

Class IIOngoing

MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Beckman Coulter, Inc.

Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

September 8, 2025 · DeviceView details →

Class IIOngoing

C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.

Iantrek Inc.

Potential for compromised integrity of the sterile packaging.

September 6, 2025 · DeviceView details →

Class IIOngoing

Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials to reinforce and maintain the cleft.

Iantrek Inc.

Potential for compromised integrity of the sterile packaging.

September 6, 2025 · DeviceView details →

Class IIIOngoing

Philips S5-2 Ultrasound Transducer

Philips Ultrasound, Inc

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

September 5, 2025 · DeviceView details →

Class IIOngoing

AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

GE Medical Systems, SCS

Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.

September 5, 2025 · DeviceView details →

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