CIOS ALPHA; image intensified fluoroscopic x-ray system
Siemens Medical Solutions USA
Class I - Dangerous
patient procedure interruption due to a potential system failure
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
May contain small amounts of ethylene glycol residue
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Innovative Sterlization Technologies
Class I - Dangerous
The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Smith & Nephew, Inc., Endoscopy Div.
Class I - Dangerous
Sterility of device is compromised due to breach in the packaging
Class I - Dangerous
In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross reference lines may be positioned incorrectly.
Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
B. Braun Medical
Class I - Dangerous
Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
Incorrect Treatment Delivery Using Third Party Fixed Wedges.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Smith & Nephew, Inc., Endoscopy Div.
Class I - Dangerous
Sterility of device is compromised due to breach in the packaging
Class I - Dangerous
Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20.
Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Smith & Nephew, Inc., Endoscopy Div.
Class I - Dangerous
Sterility of device is compromised due to breach in the packaging
Class I - Dangerous
The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The part number should be 21-2287-24 Port-A-Cath Plastic Hub Bent Needle.
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
Baxter Healthcare
Class I - Dangerous
Potential for a leak at the tubing to luer bond.
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
Biomet Microfixation
Class I - Dangerous
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue