Class I - Dangerous
Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
Class I - Dangerous
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018
Arrow International
Class I - Dangerous
These finished good kits may contain the incorrect Springwire Guide (SWG).
Inform users of correct placement of the disposable adhesive pad on the QCPR meter and inform users of injuries associated with proper performance of CPR. As required by Consent Decree of Permanent Injunction No. 1:17-cv-11955-DJC, entered October 31, 2017 between United States of America and Philips North America
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports. This pertains only to reports generated between September 23, 2017 and September 27, 2017 that used the new CareLink iPro Uploader feature.
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
DeRoyal Industries
Class I - Dangerous
DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.
Class I - Dangerous
Knee implant components (tibial bearings) are labeled with the incorrect size.
AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
Arrow International
Class I - Dangerous
These finished good kits may contain the incorrect Springwire Guide (SWG).
Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)
Philips Consumer Lifestyle
Class I - Dangerous
Device may provide inaccurate measurements.
Class I - Dangerous
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Class I - Dangerous
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Class I - Dangerous
These finished good kits may contain the incorrect Springwire Guide (SWG).
Stent possibly unable to be fully released from the delivery system.
20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
Vygon MFG, Inc., dba/ Churchill Medical Systems
Class I - Dangerous
Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
Class I - Dangerous
FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR¿1000AWS, FDR-2000AWS, FDR-3000AWS, and CR¿IR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.
Class I - Dangerous
Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
Class I - Dangerous
Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.