Class I - Dangerous
Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency alert system for all models. Older Model (legacy) without screen medical alert feature(button) removed
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Centricity Cardiology CA1000
GE Healthcare
Class I - Dangerous
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Centricity PACS RA1000
GE Healthcare
Class I - Dangerous
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
V8 Immunodisplacement Kit REF 1803
Helena Laboratories
Class I - Dangerous
Due to microbial growth causing interference with interpretation.
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Northgate Technologies
Class I - Dangerous
Product labeled incorrectly.
Class I - Dangerous
The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
Class I - Dangerous
Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
Class I - Dangerous
Software anomaly was identified.
3.2MM Pellet Insertion Tray Catalog Number: B9743
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
Becton, Dickinson and Company, BD Biosciences
Class I - Dangerous
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
3,65 m Extension Set with Luer-lock Connector
Baxter Healthcare
Class I - Dangerous
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
15 Liters Drain Bag
Baxter Healthcare
Class I - Dangerous
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
Nerve Block Tray Catalog Number: 8415
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Single Shot Epidural Tray Catalog Number: 8417
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
APD Drain Manifold
Baxter Healthcare
Class I - Dangerous
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Pain Tray Catalog Number: 9883
Busse Hospital Disposables
Class I - Dangerous
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products