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Safety Reports: Medical Devices

Updated:

Real Time Reports

Recall notice

Megadyne Electrodes - Alert to Use for ages 12+ only, USA

2 years ago •source fda.gov • details

Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA… See more

#recall #medicaldevices #unitedstates

Recalls Megadyne Electrodes - Alert to Use for ages 12+ only Megadyne issued a Class 1 Medical Device Correc... photo #1
312   Comments Comment

Recall notice

Avanos Medical MIC* Gastric-Jejunal Feeding Tube Kits recalled due to potential lack of sterility, USA

2 years ago •source fda.gov • details

Avanos Medical, Inc. voluntarily recalled specific lots of MIC* Gastric – Jejunal Feeding Tube Kits on Jan. 16, 2024. These kits include Nurse Assist supplied syringes, pre-filled with sterile water, essential for inflating the retention balloon of the feeding tube. This recall initiated in direct response to… See more

#recall #medicaldevices #unitedstates

Recalls Avanos Medical MIC* Gastric-Jejunal Feeding Tube Kits recalled due to potential lack of sterility Av... photo #1
312   Comments Comment

Recall notice

Covidien and Cardinal Health Urology and room kits and trays Update - recalled due to potential lack of sterility assurance, USA

2 years ago •source fda.gov • details

Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and operating room-specific kits and… See more

#recall #medicaldevices #unitedstates

Recalls Covidien and Cardinal Health Urology and room kits and trays Update - recalled due to potential lack... photo #1
312   Comments Comment

Recall notice

Aligned Medical Solutions Convenience kits containing saline - recalled due to safety concerns, USA

2 years ago •source fda.gov • details

Aligned Medical Solutions, initiated a nationwide recall of Convenience kits containing saline because the Product cannot be verified as having the required sterility assurance level. Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Aligned Medical Solutions distributed these kits… See more

#recall #medicaldevices #unitedstates

Recalls Aligned Medical Solutions Convenience kits containing saline - recalled due to safety concerns Align... photo #1
312   Comments Comment

Recall notice

Atrium Express Drains - recalled due to unverified sterility of provided syringes, USA

2 years ago •source fda.gov • details

Getinge / Atrium Medical Corporation notified affected customers of a nationwide recall (medical device correction) for certain Atrium Express Dry Suction Dry Seal Chest Drains in response to a voluntary medical device recall initiated by a supplier, Nurse Assist. On November 8, 2023, Getinge received notice from… See more

#recall #medicaldevices #unitedstates

Recalls Atrium Express Drains - recalled due to unverified sterility of provided syringes Getinge / Atrium M... photo #1
312   Comments Comment

Recall notice

ResMed Masks with magnets - recalled due to magnetic interference near certain implants and medical devices, USA

2 years ago •source fda.gov • details

ResMed (NYSE: RMD, ASX: RMD) is conducting a voluntary global field action to update its guides for all masks with magnets to inform users about potential magnetic interference when magnets are near certain implants and medical devices in the body. This voluntary field correction does not require… See more

#recall #medicaldevices #unitedstates

Recalls ResMed Masks with magnets - recalled due to magnetic interference near certain implants and medical... photo #1
312   Comments Comment

Recall notice

Medline, LP Tracheostomy Care and Cleaning Trays - recalled due to Device & Drug Safety, USA

2 years ago •source fda.gov • details

Medline Industries, LP. announced a voluntary nationwide recall on October 10th, 2023, of several lots and SKUs of Tracheostomy Care and Cleaning Trays. The Tracheostomy Care and Cleaning Trays include a tracheostomy brush as a component that may have sharp edges at the tip that can puncture… See more

#recall #medicaldevices #unitedstates

Recalls Medline, LP Tracheostomy Care and Cleaning Trays - recalled due to Device & Drug Safety Medline Indu... photo #1
312   Comments Comment

Recall notice

Busse Hospital Disposals Medical Device Kits and Trays - recalled due to device & drug safety, USA

2 years ago •source fda.gov • details

On November 21, 2023, Busse Hospital Disposals initiated a nationwide recall of medical device kits and trays containing (1) Nurse Assist part 6240, Stericare 100ML Sterile Saline Botle. This is the only saline contained in the trays/kits. Busse initiated this recall in direct response to Nurse Assist… See more

#recall #medicaldevices #unitedstates

Recalls Busse Hospital Disposals Medical Device Kits and Trays - recalled due to device & drug safety On Nov... photo #1
312   Comments Comment

Recall notice

Covidien and Cardinal Health Urology and OR room specific kits and trays - recalled due to lack of sterility assurance, USA

2 years ago •source fda.gov • details

In direct response to the Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology… See more

#recall #medicaldevices #unitedstates

Recalls Covidien and Cardinal Health Urology and OR room specific kits and trays - recalled due to lack of s... photo #1
312   Comments Comment

Recall notice

Baxter Novum IQ syringe infusion pump - recalled due to malfunction, USA

2 years ago •source fda.gov • details

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Novum IQ syringe infusion pump. The Correction is due to the potential for an incomplete infusion following one or more downstream occlusion alarms. Baxter notified impacted customers in October and is developing… See more

#recall #medicaldevices #unitedstates

Recalls Baxter Novum IQ syringe infusion pump - recalled due to malfunction Baxter International Inc. announ... photo #1
312   Comments Comment

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