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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 981–1000 of 1,000 recalls

Class IITerminated

Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, 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 BB7D76R13, Custom Pack BB7D76R13 CORR HL, 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 HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,

Medtronic Perfusion Systems

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

April 29, 2021 · DeviceView details →

Class IITerminated

Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29

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 HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, 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 HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 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

6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA

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

Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359

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 CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 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, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17

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 1A46R11, Custom Pack 1A46R11 Neonatal, 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"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N

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 HY7M07R6, Custom Pack HY7M07R6 E 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

6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N

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 CB1H18R20, Custom Pack CB1H18R20 Accesory, 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 HY8M63R4, Custom Pack HY8M63R4 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 HY8R62R13,Custom Pack HY8R62R13 E 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

Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA

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 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22

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

Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

Fresenius Medical Care Holdings, Inc.

Exposed to freezing temperatures due to refrigerated truck malfunctions

April 28, 2021 · DeviceView details →

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