Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesMedline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
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 FoodLoard's Horchata Ice Cream - 32 oz
Loard's Horchata Ice Cream - 32 oz
Undeclared Milk, Soy.
FDA FoodLoard's Green Tea Ice Cream - 32 oz
Loard's Green Tea Ice Cream - 32 oz
Undeclared Milk, Yellow #5.
FDA DrugsDuloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
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 Chocolate Mint Ice Cream - 32 oz; 56 oz
Loard's Chocolate Mint Ice Cream - 32 oz; 56 oz
Undeclared Milk, Soy, Yellow #5, Blue #1.
FDA FoodLoard's Chocolate Marble Ice Cream - 32 oz
Loard's Chocolate Marble Ice Cream - 32 oz
Undeclared Milk.
FDA DrugsNAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
Chemical contamination; presence of lead and lithium above specification
FDA DrugsDuloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
FDA FoodLoard's Pistachio Ice Cream - 32 oz
Loard's Pistachio Ice Cream - 32 oz
Undeclared Milk, Pistachios, Yellow #5, Blue #1.
FDA FoodLoard's Strawberry Ice Cream - 32 oz; 56 oz
Loard's Strawberry Ice Cream - 32 oz; 56 oz
Undeclared Milk, Red #40.
FDA DevicesUric Acid in vitro diagnostic test REF: 31H0P
Uric Acid in vitro diagnostic test REF: 31H0P
The devices were distributed without required FDA premarket clearance or approval.
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.
FDA FoodXZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case.
XZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case.
Product Contains undeclared FD&C Yellow #5 & #6 and Red #40
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 FoodHorizon Organic Chocolate Organic Lowfat Milk. Saleable Unit UPC: 742365004322 (6-8 FL OZ Milk Boxes). Case: ORG MILK 1% DHA CHOCOLATE 3/6PK (item 136518). Case UPC: 742365004322. Three 6-Packs, 18-8 FL OZ Containers (236 mL)/case. Individual milk boxes are packed in 8-oz Tetra Pak cartons. Distributed by: Horizon Organic Dairy, LLC (Horizon) 12303 Airport Way Suite 200 Broomfield, CO 80021. Shelf Stable, refrigerate after opening.
Horizon Organic Chocolate Organic Lowfat Milk. Saleable Unit UPC: 742365004322 (6-8 FL OZ Milk Boxes). Case: ORG MILK 1% DHA CHOCOLATE 3/6PK (item 136518). Case UPC: 742365004322. Three 6-Packs, 18-8 FL OZ Containers (236 mL)/case. Individual milk boxes are packed in 8-oz Tetra Pak cartons. Distributed by: Horizon Organic Dairy, LLC (Horizon) 12303 Airport Way Suite 200 Broomfield, CO 80021. Shelf Stable, refrigerate after opening.
Package integrity compromised.
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 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 FoodSunRidge Farms Organic SUNSET SOUP MIX CERTIFIED ORGANIC BY QAI NET WT. 25 LBS Item: 013000 UPC: 086700130001
SunRidge Farms Organic SUNSET SOUP MIX CERTIFIED ORGANIC BY QAI NET WT. 25 LBS Item: 013000 UPC: 086700130001
Potential contamination with pesticides, haloxyfop and thiamethoxam
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 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 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 FoodCostco Service Deli Department 63 MEATLOAF SEASONING MORE FLV Pack Size: 4-5lb. Bags Net Weight: 20lbs Allergy Information: CONTAINS: MILK, WHEAT Packed BY: Griffith Foods STONECREST, GA 30058
Costco Service Deli Department 63 MEATLOAF SEASONING MORE FLV Pack Size: 4-5lb. Bags Net Weight: 20lbs Allergy Information: CONTAINS: MILK, WHEAT Packed BY: Griffith Foods STONECREST, GA 30058
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
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 FoodChocolate Showers Ice Cream - 32 oz (5 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods, and Berkeley Bowl) UPC: 8-12017-00918
Chocolate Showers Ice Cream - 32 oz (5 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods, and Berkeley Bowl) UPC: 8-12017-00918
Undeclared Soy (with mitigating circumstances)