Safety Recall Directory

GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A

The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

Clover Hill Dairy LLP, Smoked Pepper Cheese Varieties (Jalapeno Cheddar), sold in 1/2-lb and 1-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.

Product contaminated with Listeria monocytogenes.

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No

Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.

5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905

Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.

"***Hondashi 0.25oz***" seasoning packed in silver plastic/metallic pouch, pouches packed in brown paperboard cartons (600 packets/carton), Carton label reads in part as "***Hondashi 0.25oz*600bags/ctn, Ingredients: salt, sodium glutamate, bonito, cornstarch, maltodextrin, water, flavored sodium nucleotide, glucose, soybean protein powder Allergen: Soybean, 1025 Ave S, Ste 150, Grand Prairie, TX 75050***"

Allergen missing from contains statement: fish

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05

Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.

Clover Hill Dairy LLP, sharp cheese variety (Cheddar, Yummy Cheddar, White Cheddar, Monterey Jack). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, and 5-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.

Product contaminated with Listeria monocytogenes.

Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Snack Pack Assorted Pepperjack Stix (Jalapeno Cheddar, Pepper Jack)). Sold in approximate 0.40-lb (6.4oz) units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.

Product contaminated with Listeria monocytogenes.

Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller

If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

Clover Hill Dairy LLP, Mild Cheese Variety (Yummy Cheddar, White Cheddar, White Colby, Monterey Jack, Marble Jack). Sold in 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.

Product contaminated with Listeria monocytogenes.

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

Mack Trucks, Inc. - Marker Lights May Fail to Illuminate/FMVSS 108

Marker lights that fail to illuminate can reduce visibility, increasing the risk of a crash.

FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.

Devices could potentially contain an occluded or partially occluded Guedel Airway tip.

Volvo Trucks North America - Marker Lights May Fail to Illuminate/FMVSS 108

Marker lights that fail to illuminate can reduce visibility, increasing the risk of a crash.

KC Everyday Mac & Cheese, 3lb x 6. Item # 20609055. 6 - 3 lb pouches, Net Wt: 18 lb. (8.16Kg). Fully Cooked. Keep Frozen. Distributed By: Kerry Inc, Beloit, WI 53511.

Undeclared allergen (egg)

Flexible food pouch (3-layer foil, spouted, #CP6088), manufactured for packaging Pumpkin Tree Peter Rabbit Organics Banana & Strawberry, 4 oz food puree, UPC 815367010780.

Flexible food pouch may release thin plastic strips into food.

Hardie’s Fresh Foods Recalls Jalapenos Because of Possible Health Risk

GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph

Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.

Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2 ) is a portable and handheld x-ray system designed to aid clinicians with point of care visualization through diagnostic x-rays of extremities and shoulders. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and can be charged with either a wired or wireless charger. The system is intended to interface wirelessly to an external tablet or display when used with the OXOS Device App. The MC2 utilizes an infrared Tracking System and Viewfinder that allows the operator to position the emitter within a safe source-to-image distance (SID) and allows the operator to visualize the anatomy and x-ray field projection prior to initiating an x-ray acquisition. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance. Component: The MC2 Portable X-Ray System is not a component.

Due to a defective circuit board that overheats

REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument

Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm

Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

UPDATED 13.08.26 | Edesia Enterprises Pty Ltd T/A noosa GOURMET - Brioche Rolls - 320g

The presence of undeclared allergens (milk and egg).