Class I - Dangerous
Incorrect Unique Device Identifier/GTIN code was used on product.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Class I - Dangerous
Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions for Use ("IFU").
Class I - Dangerous
There is a potential for breakage of the small screw used to affix the anti-backout plate.
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Smith & Nephew
Class I - Dangerous
A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
Due to potential software issue that may result in patient mix-up information.
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
The CirClamp subassembly found in the kit was the incorrect size.
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.
Class I - Dangerous
Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
Class I - Dangerous
There is a potential for breakage of the small screw used to affix the anti-backout plate.
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
BioFire Diagnostics
Class I - Dangerous
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976
Ortho-Clinical Diagnostics
Class I - Dangerous
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
Class I - Dangerous
There is a potential for breakage of the small screw used to affix the anti-backout plate.
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L
Compass Health Brands (Corporate Office)
Class I - Dangerous
Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication
Class I - Dangerous
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Class I - Dangerous
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
Olympus Corporation of the Americas
Class I - Dangerous
There have been complaints that the clip did not come out of the tube sheath during the procedure.
A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.
Class I - Dangerous
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
Medtronic Neuromodulation
Class I - Dangerous
Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.