Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Australia ProductsNevenka Baby pull string giraffe toy
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.
FDA DevicesHalyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
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.
FDA FoodClover 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.
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.
FDA DevicesSTRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
FDA DevicesBrand 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
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.
FDA DevicesSyva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
RappelConsothe glowhouse - flashing princess wand
the glowhouse - flashing princess wand
accessibilité des piles boutons consécutive à la présence d'une vis perdable. risque d'ingestion, de brûlure ou d'intoxication.
FDA FoodClover Hill Dairy LLP, Pepper Jack Cheese Varieties (Jalapeno Cheddar, Pepper Jack, Sizzlin Colby with Habanero Peppers). Sold in approximate 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.
Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Jalapeno Cheddar, Pepper Jack, Sizzlin Colby with Habanero Peppers). Sold in approximate 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.
FDA DevicesNerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
FDA DevicesBrand 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
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.
FDA DevicesHardyDisk 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,
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.
FDA DevicesRadial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
Potential for breach in sterile barrier of device packaging.
FDA FoodClover Hill Dairy LLP, Soft Ricotta (Requeson), and Soft Ricotta with Jalapenos (Requeson Con Chile). Sold in 2- and 5-gallon buckets, and 10oz, 12oz, and 14oz individually packaged food grade clamshell containers. The 5- and 2-gallon buckets are shrink wrapped. Keep refrigerated.
Clover Hill Dairy LLP, Soft Ricotta (Requeson), and Soft Ricotta with Jalapenos (Requeson Con Chile). Sold in 2- and 5-gallon buckets, and 10oz, 12oz, and 14oz individually packaged food grade clamshell containers. The 5- and 2-gallon buckets are shrink wrapped. Keep refrigerated.
Product contaminated with Listeria monocytogenes.
FDA DevicesSTRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
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.
FDA DevicesSTRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
FDA DevicesBrand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 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.
FDA DevicesMerge PACS, medical imaging diagnostic workstation
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.
FDA FoodClover 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.
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.
FDA FoodBlank Slate Creamery VEGAN NON-DAIRY FROZEN DESSERT COCONUT FUDGE SANDWICHES, 4.5 oz clear plastic package
Blank Slate Creamery VEGAN NON-DAIRY FROZEN DESSERT COCONUT FUDGE SANDWICHES, 4.5 oz clear plastic package
undeclared egg
FDA FoodSliced Korean Halibut with Soy sauce, Wasabi, Vinegar Chili Paste; Keep Frozen; Net WT: 12.2OZ (374g); UPC: 6 78108 16991 4
Sliced Korean Halibut with Soy sauce, Wasabi, Vinegar Chili Paste; Keep Frozen; Net WT: 12.2OZ (374g); UPC: 6 78108 16991 4
Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.
FDA FoodFLOUNDER SASHIMI WITH SAUCE; Keep Frozen; Net WT: 300g; UPC: 8 809342 366186
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.
FDA DevicesBrand 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
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.
FDA DevicesRadial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240cm Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240cm Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.
Potential for breach in sterile barrier of device packaging.
FDA Devicesmunevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.