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Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LL...
sub potency
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Octopus Evolution AS Tissue Stabilizer, Model TS2500
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephi...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl ...
Non-Sterility: Due to presence of Aspergillus penicillioides.
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient speci...
Incorrect product formulation: bag did not contain copper and famotidine per label.
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye...
Lack of Assurance of Sterility
Joy Pineapple Lassi 16 oz.
Product not adequately pasteurized
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: ...
CGMP Deviations
Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC01...
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Chrysler (FCA US, LLC) - Parking & Daytime Running Lights May Fail/FMVSS 108
Parking lights and daytime running lights that fail to illuminate properly reduce the vehicle's visibility to other drivers, increasing the risk of a crash.
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isop...
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
TMJ Bilateral Implants, REF: CHG020
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
les moulinettes - fusilli blé dur - fusilli blé dur
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
INZONE DETACHMENT SYSTEM, REF: M00345100950
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
Eunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx on...
Presence of foreign substance
Dried Herring Fish 7 oz.
Improperly eviscerated which may result in Clostridium botulinum contamination
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, M...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
les moulinettes - coquillettes blé dur
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire