ACS Cath Lab Pack
American Contract Systems
Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
BF-MP60: OES Bronchofiberscope
Olympus Corporation of the Americas
Class I - Dangerous
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
ACS Lap Chole Pack
American Contract Systems
Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
Class I - Dangerous
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
BF-1TQ180: EVIS EXERA II Bronchovideoscope
Olympus Corporation of the Americas
Class I - Dangerous
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
SIMPLIVIA HEALTHCARE
Class I - Dangerous
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.
Class I - Dangerous
When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg. An applied cuff inflation pressure higher than 150mmHg or a deflation pressure higher than 5 could lead to bruising, mmHg nerve damage or bone deformity for a neonate.
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
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.
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.
TMJ Arthroscopy Drape, 85''x 96''
Microtek Medical
Class I - Dangerous
Latex content in product was labeled incorrectly as latex free.
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.
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
Kits were packed into shipping boxes incorrectly.
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.