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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 901–920 of 1,000 recalls

Class IITerminated

Hays Ultrasound kit Item ID: H1000SE

Exact Medical Manufacturing, Inc.

No 510k for the product to be used in a natural or surgical opening to the body

April 29, 2021 · DeviceView details →

Class IITerminated

6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA

Exact Medical Manufacturing, Inc.

No 510k for the product to be used in a natural or surgical opening to the body

April 29, 2021 · DeviceView details →

Class II

Terminated

Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576

Exact Medical Manufacturing, Inc.

No 510k for the product to be used in a natural or surgical opening to the body

April 29, 2021 · DeviceView details →

Class IITerminated

Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N

Exact Medical Manufacturing, Inc.

No 510k for the product to be used in a natural or surgical opening to the body

April 29, 2021 · DeviceView details →

Class IITerminated

Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N

Exact Medical Manufacturing, Inc.

No 510k for the product to be used in a natural or surgical opening to the body

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664

Exact Medical Manufacturing, Inc.

No 510k for the product to be used in a natural or surgical opening to the body

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA

Exact Medical Manufacturing, Inc.

No 510k for the product to be used in a natural or surgical opening to the body

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N

Exact Medical Manufacturing, Inc.

No 510k for the product to be used in a natural or surgical opening to the body

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

Class IITerminated

Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.

Medtronic Perfusion Systems

Specific lots may have been manufactured with insufficient or incomplete welds.

April 29, 2021 · DeviceView details →

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