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BMW of North America, LLC - Integrated Brake System Malfunction
A loss of power brake assist can extend the distance required to stop the vehicle. Additionally, malfunctioning ABS and/or DSC systems can cause a loss of vehicle control. Either of these scenarios can increase the risk of a crash.
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.
Spring & Mulberry Coffee Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), indivi...
Potential Salmonella contamination
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 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.
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.
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Num...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
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.
fiat professional - grande panda, 600 voiture particulière
il n'y a pas suffisamment de dégagement (< 10 mm) entre le tube du filtre à particules à essence et le capuchon de protection terminal de l'alternateur de démarrage à courroie de 48 v. dans des conditions humides, le manque de dégagement et de contact entre ces composants peut entraîner une infiltration d'eau, provoquant un arc électrique qui peut déclencher un événement thermique, tel qu'une surchauffe. il y a un risque d'incendie.
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.
Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Joy Sweet Lassi 16 oz.
Product not adequately pasteurized
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 5551...
Presence of Foreign Substance.
les moulinettes - fusilli blé dur - fusilli blé dur
taux de t-2 toxine et ht-2 toxine supérieures à la valeur réglementaire
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.
Spring & Mulberry Blood Orange Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), ...
Potential Salmonella contamination
El David Gelee, Bonbons with fruits Soft & Juicy, 400g. Packaged in decorated pa...
Undeclared colors (FD&C Yellow 5 and FD&C Red 40).
1.5oz Zapp's Bayou Blackened Ranch Kettle Chips, Plastic Bag.
Potential presence of Salmonella.
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Joy Mint Lassi 16 oz.
Product not adequately pasteurized
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl...
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.
Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ ...
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.