Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA FoodPeppermint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00933
Peppermint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00933
Undeclared Red #40
FDA DrugsDuloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
FDA FoodLoard's Brownie Nut Fudge Ice Cream - 32 oz
Loard's Brownie Nut Fudge Ice Cream - 32 oz
Undeclared Milk, Walnuts, Eggs, Wheat, Soy.
FDA FoodBlackberry Creamed Honey 671333101308 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey.The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101308
Blackberry Creamed Honey 671333101308 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey.The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101308
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
FDA FoodLoard's Peppermint Ice Cream - 32 oz; 56 oz
Loard's Peppermint Ice Cream - 32 oz; 56 oz
Undeclared Milk, Soy, Red #40.
FDA DevicesProdisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
FDA DevicesSee RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W;
See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W;
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.
FDA DevicesERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
FDA DevicesCentimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
FDA DevicesOne Step UTI in vitro diagnostic test REF: 3374
One Step UTI in vitro diagnostic test REF: 3374
The devices were distributed without required FDA premarket clearance or approval.
FDA DevicesMedline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
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.
FDA DevicesMint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
FDA DevicesMedline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
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.
FDA FoodGarland Fresh Peeled Garlic 6 oz. bag
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
Germany BVLVom Land Heidelbeerkonfitüre Extra, 450 Gramm
Vom Land Heidelbeerkonfitüre Extra, 450 Gramm
Fremdkörper
FDA FoodLoard's Peanut Butter Fudge Ice Cream - 32 oz
Loard's Peanut Butter Fudge Ice Cream - 32 oz
Undeclared Milk, Peanuts.
FDA FoodFain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
Fain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
FDA FoodLoard's Champagne Sherbert - 32 oz
Loard's Champagne Sherbert - 32 oz
Undeclared Milk, Red #40.
FDA FoodBurgundy Cherry Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00909
Burgundy Cherry Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00909
Undeclared Red #40, Blue #1, Blue #2
FDA FoodLoard's Ube Ice Cream - 32 oz
Loard's Ube Ice Cream - 32 oz
Undeclared Milk, Red #3, Red #40, Blue #1, Blue #2.
FDA FoodLoard's Chocolate Marble Ice Cream - 32 oz
Loard's Chocolate Marble Ice Cream - 32 oz
Undeclared Milk.
FDA FoodRAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001177 16 oz (454g) UPC: 835204000156
RAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001177 16 oz (454g) UPC: 835204000156
Multi-state outbreak of E. coli O157:H7.
FDA FoodLoard's Pistachio Ice Cream - 32 oz
Loard's Pistachio Ice Cream - 32 oz
Undeclared Milk, Pistachios, Yellow #5, Blue #1.
FDA FoodCinnamon Creamed Honey 671333101360 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC: 671333101360
Cinnamon Creamed Honey 671333101360 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC: 671333101360
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.