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Safety Reports: Medical Devices

Updated:

Real Time Reports

Recall notice

Cook Medical Transseptal Needle and Transseptal Needle Catheter - recalled due to Complaints of rust on the products, USA

4 years ago •source fda.gov • details

Company name: Cook Medical
Brand name: Cook Medical
Product recalled: Transseptal Needle and Transseptal Needle Catheter
Reason of the recall: Complaints of rust on the products
FDA Recall date: October 19, 2021
Recall details: Bloomington, Ind. — On October 8, 2021, Cook Medical issued a global, voluntary… See more

#recall #medicaldevices #unitedstates

Recalls Cook Medical Transseptal Needle and Transseptal Needle Catheter - recalled due to Complaints of rust... photo #1
312   Comments Comment

Recall notice

LeadCare® Test Kits - recalled due to underestimated blood lead levels, USA

4 years ago •source fda.gov • details

Company name: Meridian Bioscience, Inc.
Brand name: Meridian Bioscience, Inc.
Product recalled: LeadCare® Test Kits
Reason of the recall: LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples
FDA Recall date: September 02, 2021
Recall details: Meridian Bioscience, Inc. (NASDAQ: VIVO),… See more

#blood #recall #medicaldevices #unitedstates

312   Comments Comment

Recall notice

Spectrum IQ Infusion Pumps - recalled due to Multiple Connectivity Errors, USA

4 years ago •source fda.gov • details

Company name: Baxter International Inc.
Brand name: Spectrum IQ
Product recalled: Infusion Pumps
Reason of the recall: Multiple Connectivity Errors
FDA Recall date: August 24, 2021
Recall details: Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for all Spectrum IQ infusion pumps… See more

#recall #medicaldevices #unitedstates

312   Comments Comment

Recall notice

Monoject Flush Prefilled Saline Syringes - recalled due to air reintroducing into the syringe, USA

4 years ago •source fda.gov • details

Company name: Cardinal Health
Brand name: Monoject
Product recalled: Flush Prefilled Saline Syringes
Reason of the recall: Products have been found to reintroduce air into the syringe after the air has been expelled
FDA Recall date: August 20, 2021
Recall details: On August 4, 2021, Cardinal Health… See more

#blood #recall #medicaldevices #unitedstates

Recalls Monoject Flush Prefilled Saline Syringes - recalled due to air reintroducing into the syringe Compan... photo #1
312   Comments Comment

Recall notice

Ultrasound Gel - recalled due to product is contaminated with bacteria, USA

4 years ago •source fda.gov • details

Company name: Eco-Med Pharmaceutical
Brand name: Multiple brand names
Product recalled: Ultrasound Gel
Reason of the recall: Product is contaminated with bacteria (Burkholderia cepacia complex)
FDA Recall date: August 04, 2021
Recall details: Etobicoke, Ontario (August 4, 2021) – Eco-Med Pharmaceuticals, Inc. today commenced a voluntary recall… See more

#recall #medicaldevices #unitedstates

312   Comments Comment

Recall notice

BD Alaris System - recalled due to Infusion pump may not operate as expected, USA

4 years ago •source fda.gov • details

Company name: Becton, Dickinson and Company
Brand name: BD
Product recalled: Alaris System
Reason of the recall: Infusion pump may not operate as expected
FDA Recall date: August 02, 2021
Recall details: FRANKLIN LAKES, N.J., July 29, 2021 /PRNewswire/ BD (Becton, Dickinson and Company) (NYSE: BDX), a… See more

#blood #recall #medicaldevices #unitedstates

312   Comments Comment

Recall notice

Hypodermic Needle Insulin Syringes - recalled due to skewed markings on syringes, USA

4 years ago •source fda.gov • details

Company name: Smiths Medical
Brand name: Jelco
Product recalled: Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Reason of the recall: Skewed odd number line graduation markings on syringe barrels.
FDA Recall date: June 17, 2021
Recall details: Company Announcement Smiths Medical has become aware of specific models and… See more

#recall #medicaldevices #unitedstates

312   Comments Comment

Recall notice

Philips pressure and mechanical ventilator devices - recalled due to health risks, USA

4 years ago •source fda.gov • details

Company name: Philips
Brand name: Philips
Product recalled: Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices
Reason of the recall: Potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices
FDA Recall date:… See more

#recall #medicaldevices #unitedstates

312   Comments Comment

Recall notice

ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator - recalled due to defective applicator, USA

4 years ago •source fda.gov • details

Company name: Becton, Dickinson and Company
Brand name: ChloraPrep
Product recalled: ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator
Reason of the recall: Defective applicator
FDA Recall date: April 20, 2021
Recall details: BD (Becton, Dickinson and Company), a leading global medical technology company, is voluntarily recalling specified lots… See more

#blood #medicaldevices #recall #unitedstates #orange

312   Comments Comment

Recall notice

Tenacore LLC 2001 Tenacore Replacement CareFusion Alaris 8100 bezels - recalled due to Potentially weakened elastic, USA

4 years ago •source fda.gov • details

Company name: Tenacore LLC
Brand name: Tenacore LLC
Product recalled: 2001 Tenacore Replacement CareFusion Alaris 8100 bezels
Reason of the recall: Potentially weakened elastic
FDA Recall date: April 19, 2021
Recall details: Company Announcement On February 24th, 2021, Tenacore LLC initiated a nationwide recall of 2001 Tenacore… See more

#medicaldevices #unitedstates

Recalls Tenacore LLC 2001 Tenacore Replacement CareFusion Alaris 8100 bezels - recalled due to Potentially w... photo #1
313   Comments Comment

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