Estados Unidos Recalls

Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A

Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.

Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case,

The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.

Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

Surgical dressing manufactured out of specification (greater thickness).

GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.

Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

E-One Incorporated - Drive Mode May Disengage Causing a Loss of Drive Power

Loss of power to the rear wheels can prevent the vehicle from moving, increasing the risk of a crash.

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

Khong Guan Corporation Issues Expanded Recall of Glutinous Rice Balls With Black Sesame Filling to Include Black & White Glutinous Rice Balls With Black Sesame Filling Due to Undeclared Peanuts

Orange EV - Frame Rails May Crack

A detached rail can cause a loss of control, increasing the risk of injury.

Nissan North America, Inc. - Incorrect GAWR on Certification Label/FMVSS 110

An overloaded vehicle can increase the risk of a crash.

Smoked Sausage Spice 32.86#

Undeclared Sesame allergen

Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01

Lack of Sterility Assurance

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.

Due to packaging discrepancy with incorrect product size mixed up.

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.

Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529

Subpotent drug

Ford Motor Company - Roof Rail Covers May Detach

A detached roof rail cover can create a road hazard, increasing the risk of a crash.

Wabash National Corporation - Liftgate Deck Pins May Break

A liftgate that falls unexpectedly increases the risk of injury.

Ford Motor Company - Second-Row Seat May Move Unexpectedly

A seat that moves unexpectedly may not properly restrain an occupant during a crash, increasing the risk of injury.

Ford Motor Company - Trailer Brakes and Lighting May Be Lost/FMVSS 108

A loss of trailer brakes or lights can reduce the driver’s ability to control the trailer and decrease the trailers visibility to other road users, increasing the risk of a crash.

Winnebago Industries, Inc. - Printed Circuit Board May Overheat

An overheated printed circuit board increases the risk of a fire.

Hyundai Motor America - Seat Belt Buckle May Fail

A seat belt buckle that fails to properly restrain an occupant in a crash increases the risk of injury.

Khong Guan Corporation Issues Recall of Glutinous Rice Balls With Black Sesame Filling Due to Undeclared Peanuts

Zoox, Inc. - ADS Software May Fail to Detect and Respond to Heavy Smoke

Failing to respond to low visibility conditions can increase the risk of a crash or impede first responders.

Tenneco Automotive - Loss of Steering

A loss of steering increases the risk of a crash.