TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Johnson & Johnson Surgical Vision
🏥 Medical Devices Class I - Dangerous
Potential breach in the sterility barrier for tray ring covers.
All Recalls
95,025 total recalls in our database
K-Wire, 1.35 mm x 170 mm
Arthrex
🏥 Medical Devices Class I - Dangerous
Products do not meet length and diameter specifications.
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Restrata, Part Number RWM1-2X2
Acera Surgical
🏥 Medical Devices Class I - Dangerous
Misprinted expiration date on the shelf-box
🏥 Medical Devices Class I - Dangerous
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Becton Dickinson &
🏥 Medical Devices Class I - Dangerous
When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
VELYS Robotic-Assisted Solution Base Product No.: 451570100
DePuy Orthopaedics
🏥 Medical Devices Class I - Dangerous
System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment
🏥 Medical Devices Class I - Dangerous
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
🏥 Medical Devices Class I - Dangerous
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
SML Distribution
🏥 Medical Devices Class I - Dangerous
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
🏥 Medical Devices Class I - Dangerous
Kits contained recalled acetaminophen.
ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Azurion systems with software release R1.x
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
BIBS Baby Bottles
BIBS Denmark ApS, of Denmark
🏠 Consumer Products Class II - Moderate
Hot liquids in the bottle can cause the bumper to shrink, making the bottle tilt over spilling out contents, posing a burn hazard.
Children's robes
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The children's robes fail to meet flammability standards for children's sleepwear, posing a risk of burn injuries to children.
Children's Robes
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The children's robes fail to meet the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.