Safety Recall Directory

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).

Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK 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: NCOCO2075 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.

Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival 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.

Nevenka Baby pull string giraffe toy

The product does not comply with the mandatory standard for toys for children up to and including 36 months of age . The product’s silicone pull strings that are too long and can reach the back of a child's throat causing choking or asphyxiation. The feet on the ends of the silicone pull strings can detach from the product and cause a child to choke if they place them in their mouth.

Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD 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: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front 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: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450 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.

INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.

Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

Merge PACS, 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.

sans marque / vendus au rayon traditionnel - crevettes entières cuites réfrigérées élevées à madagscar - calibre 10/20 sx

présence de listeria monocytogenes détectée lors d'une analyse microbilogique.

manicamp - manicamp

présence potentielle de listéria monocytogenes

Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm

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.

Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40

Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.

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.

Oma's Pride Voluntarily Recalls One Lot of Woof Complete Canine Chicken Recipe (6 Lb Bag) Because of Possible Salmonella Health Risk

HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to Cefiderocol,

Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.

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

The presence of undeclared allergens (milk and egg).

Blank Slate Creamery VEGAN NON-DAIRY FROZEN DESSERT COCONUT FUDGE SANDWICHES, 4.5 oz clear plastic package

undeclared egg

Big Way Hot Pot "Hot Pot Miso Paste"; 1kg (35.3oz) unit package. Product is packaged in generic bulk packaging.

Undeclared milk from lactose.

FLOUNDER SASHIMI WITH SAUCE; Keep Frozen; Net WT: 300g; UPC: 8 809342 366186

Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.

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.

Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1

Presence of Particulate Matter; identified as stainless steel

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.