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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 221–240 of 392 recalls

Class IICompleted

IceRod" 1.5 MRI 90¿ Cryoablation Needle¿

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →

Class IICompleted

IcePearl" 2.1 CX Prostate Cryoablation Kit

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →

Completed

IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →

Class IICompleted

IceSphere" 1.5 90¿ Cryoablation Needle

Boston Scientific Corporation

Complaint trend regarding needle shaft gas leaks.

November 18, 2020 · DeviceView details →

Class IICompleted

6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Chromsystems Instruments & Chemicals GmbH

Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

October 29, 2020 · DeviceView details →

Class IICompleted

MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Chromsystems Instruments & Chemicals GmbH

Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

October 29, 2020 · DeviceView details →

Class IICompleted

MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Chromsystems Instruments & Chemicals GmbH

Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

October 29, 2020 · DeviceView details →

Class IICompleted

Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

Mako Surgical Corporation

Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.

October 23, 2020 · DeviceView details →

Class IICompleted

Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.

Percussionaire Corporation

Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL microprocessor chips and firmware.

September 14, 2020 · DeviceView details →

Class IICompleted

Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

Fresenius Medical Care Holdings, Inc.

The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.

September 12, 2020 · DeviceView details →

Class IICompleted

CarePoint 60 mL Syringe Without Needle, REF: 04-7560

Allison Medical, Inc.

Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.

September 3, 2020 · DeviceView details →

Class IICompleted

PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200, LLC

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

July 29, 2020 · DeviceView details →

Class IICompleted

PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200, LLC

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

July 29, 2020 · DeviceView details →

Class IICompleted

PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200, LLC

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

July 29, 2020 · DeviceView details →

Class IICompleted

PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200, LLC

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

July 29, 2020 · DeviceView details →

Class IICompleted

PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200, LLC

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

July 29, 2020 · DeviceView details →

Class IICompleted

PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200, LLC

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

July 29, 2020 · DeviceView details →

Class IICompleted

PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200, LLC

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

July 29, 2020 · DeviceView details →

Class IICompleted

PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

Cardinal Health 200, LLC

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

July 29, 2020 · DeviceView details →

Class IICompleted

Medtronic SynchroMed, Model A10

Medtronic Inc.

The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.

July 13, 2020 · DeviceView details →

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