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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 921–940 of 1,000 recalls

Class IITerminated

Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, 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

Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360

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 CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, 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

Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL

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 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 →
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