United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
One Step pH in vitro diagnostic test REF: 31I4P
The devices were distributed without required FDA premarket clearance or approval.
Garland Fresh Peeled Garlic 6 oz. bag
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
Banana Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piaz...
Undeclared Yellow #5
Loard's Lime Sherbert - 32 oz
Undeclared Milk, Wheat, Soy, Yellow #5, Green #3.
Loard's Ube Ice Cream - 32 oz
Undeclared Milk, Red #3, Red #40, Blue #1, Blue #2.
RAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOL...
Multi-state outbreak of E. coli O157:H7.
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2)...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog N...
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Loard's Butterscotch Marble Ice Cream - 32 oz
Undeclared Milk.
Loard's Maple Walnut Ice Cream - 32 oz
Undeclared Milk, Walnuts, Sulfites.
Loard's Green Tea Ice Cream - 32 oz
Undeclared Milk, Yellow #5.
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PAC...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog ...
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.
See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS,...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; ...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Loard's Cookies and Cream Ice Cream - 32 oz; 56 oz
Undeclared Milk, Wheat, Soy.
Loard's Mocha Chip Ice Cream - 32 oz; 56 oz
Undeclared Milk.
Loard's Raspberry Sherbert - 32 oz
Undeclared Milk, Red #40.
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc...
Lack of assurance of Sterility: potential product contamination
TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag,...
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KI...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Loard's Coffee Ice Cream - 32 oz
Undeclared Milk.