Safety Recall Directory

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.

Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 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.

Ultimate Mother's Day Wangshin Doenjang Aged 3 Years 9 oz. Korean Traditional Premium Soybean Paste UPC: 8 809897 940169

Product label allergen "contains" statement does not include anchovy(fish)

Kettle Cuisine Recalls Marketside Tomato Bisque Soup Kit – Sold Exclusively at Walmart Stores Because of Possible Health Risk

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm

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.

Clover Hill Dairy LLP, mild cheese variety (Snack Pack Assorted Regular Mild Stix White Colby, Marble Jack, Yummy Cheddar). 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.

Clover Hill Dairy LLP, Smoked Cheddar Cheese Varieties (Cheddar, White 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.

Clover Hill Dairy LLP, Soft Cuajada (vacuum sealed), sold in 14oz- and 2.5 lb clam shells, and 5-lb bags. Unknown information: labeling, or total quantity of product distributed. Keep refrigerated.

Product contaminated with Listeria monocytogenes.

STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

"***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

Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.

Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).

Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) 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.

Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system

A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).

BMW of North America, LLC - Incorrectly Attached Steering Spindle

An incorrectly attached steering spindle can lead to a loss of steering control, increasing the risk of a crash.

Merge OrthoPACS, medical imaging diagnostic workstation

Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 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.

BMW of North America, LLC - Loss of Rear Wheel Power from Driveshaft Damage

An unexpected loss of drive power can increase the risk of a crash. In addition, a damaged driveshaft can result in a vehicle rollaway if the parking brake is not applied, increasing the risk of a crash or injury.

Clover Hill Dairy LLP, Mild Cheese Variety (3-in-a-pack assorted White Colby, Marble Jack, Yummy Cheddar). Sold in approximate 0.20-lb (3.2oz) units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.

Product contaminated with Listeria monocytogenes.

Kingfisher Compact Individual First Aid Kit. REF Number: 76656. 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.

Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.

Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 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.

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 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.