Class I - Dangerous
Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
Karl Storz Endoscopy
Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.
TMJ Arthroscopy Drape, 85''x 96''
Microtek Medical
Class I - Dangerous
Latex content in product was labeled incorrectly as latex free.
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Diagnostic Kit SARS-cCo V Antigen Rapid Test
USA Medical
Class I - Dangerous
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
Karl Storz Endoscopy
Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
American Contract Systems
Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Shanghai United Imaging Healthcare Co.
Class I - Dangerous
X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
American Contract Systems
Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)
Karl Storz Endoscopy
Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018); 11272VNU 11272VNUK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
Karl Storz Endoscopy
Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Class I - Dangerous
Patient chart label contains incorrect Part Number and volume amount.
Class I - Dangerous
Kits were packed into shipping boxes incorrectly.
Accula SARS-CoV-2 Test, REF: COV4100
MESA BIOTECH
Class I - Dangerous
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.
Daavlin Distributing Company
Class I - Dangerous
Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
ACS IR - Angio Pack
American Contract Systems
Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
Class I - Dangerous
There is a potential for foreign matter.
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Siemens Healthcare Diagnostics
Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results