95,102 total recalls in our database
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.
B. Braun Medical
Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
May contain small amounts of ethylene glycol residue
May contain small amounts of ethylene glycol residue
Incorrect Treatment Delivery Using Third Party Fixed Wedges.
Smith & Nephew, Inc., Endoscopy Div.
Sterility of device is compromised due to breach in the packaging
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, Inc., Endoscopy Div.
Sterility of device is compromised due to breach in the packaging
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.
Baxter Healthcare
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.
May contain small amounts of ethylene glycol residue
Biomet Microfixation
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.
May contain small amounts of ethylene glycol residue
May contain small amounts of ethylene glycol residue
Smith & Nephew, Inc., Endoscopy Div.
Sterility of device is compromised due to breach in the packaging
May contain small amounts of ethylene glycol residue
May contain small amounts of ethylene glycol residue
Natus Medical Incorporated
The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.
This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened).