United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS...
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) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ871...
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.
One Step P in vitro diagnostic test REF: 8194
The devices were distributed without required FDA premarket clearance or approval.
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; ...
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.
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.
One Step pH in vitro diagnostic test REF: 31I4P
The devices were distributed without required FDA premarket clearance or approval.
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx O...
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
Hiab USA Inc. - Liftgate Deck Pins May Break
A liftgate that falls unexpectedly increases the risk of injury.
Loard's Banana Ice Cream - 32 oz; 56 oz
Undeclared Milk, Yellow #5.
Loard's Pumpkin Ice Cream - 32 oz
Undeclared Milk, Yellow #6.
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Lemon Creamed Honey, 671333101353 *These product labels may also say Whipped Ho...
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Modu...
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number...
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Woodstock Organic Shelled Edamame 10 oz. and 48 oz.
Foreign object: metal pieces
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) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LV...
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.
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Contamination to in-vitro diagnostic test may result in false positives.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 ...
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B...
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 Blueberry Cheesecake Ice Cream - 32 oz
Undeclared Milk, Red #40, Blue #1.
Horizon Organic Chocolate Organic Lowfat Milk. Saleable Unit UPC: 742365004322 (...
Package integrity compromised.
See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number...
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.