United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
EL MEXICANO horchata casera Instant Horchata Drink NET WT 14oz (396g) INGREDIENT...
Undeclared milk.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
Bombay Kitchen brand Punjabi Mix; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour...
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 ...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2)...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Kirkland Signature Traditional Madeleines 12 Count/net wt. 18oz., Item #2000012,...
Undeclared hazelnut and soy lecithin.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ...
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm...
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116...
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
Newmar Corporation - Incorrect Cargo Carrying Capacity on Label/FMVSS 120
Incorrect weight information can allow the vehicle to be overloaded, increasing the risk of a crash.
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number:...
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog...
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, ...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)1080...
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119...
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton ( 2.8 oz pouch ) and 7.7 oz Car...
Hard corn starch lumps were found in the product
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plu...
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)108019022203...
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured