Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA FoodCross Valley Farms LETTUCE SALAD MIX 4/5# Cross Valley Farms LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products.
Cross Valley Farms LETTUCE SALAD MIX 4/5# Cross Valley Farms LETTUCE SALAD WITH SEP BAG 4/5# Iceberg, Carrots, Red Cabbage products.
Potential Cyclospora contamination.
FDA FoodMARKON LETTUCE CHOP 4/5# MARKON LETTUCE SHRED 1/4" 4/5# MARKON LETTUCE SHRED 1/8" 4/5# MARKON LETTUCE SHRED 3/8" 4/5# Iceberg only products.
MARKON LETTUCE CHOP 4/5# MARKON LETTUCE SHRED 1/4" 4/5# MARKON LETTUCE SHRED 1/8" 4/5# MARKON LETTUCE SHRED 3/8" 4/5# Iceberg only products.
Potential Cyclospora contamination.
RSS FeedOptimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels
Optimal Balance Pharmacy Issues Voluntary Nationwide Recall of Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials Due to Elevated Endotoxin Levels
FDA FoodMARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.
MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.
Potential Cyclospora contamination.
FDA DrugsCLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
Lack of assurance of sterility. The recall is due to potential contamination
FDA FoodTAYLOR FARMS BLEND GARDEN SALAD MIX W/ROM 6/5# NATIONAL TAYLOR FARMS BLEND GARDEN SALAD MIX W/ROM 6/5# ND TAYLOR FARMS BLEND LETT/ROM 50/50 NOCLR 4/5# TAYLOR FARMS BLEND LETT/ROM 70/30 NOCOLR 4/5# TAYLOR FARMS BLEND LETT/ROM 80/20 4/5# TAYLOR FARMS LETTUCE SALAD MIX 4/5# Iceberg, Romaine products.
TAYLOR FARMS BLEND GARDEN SALAD MIX W/ROM 6/5# NATIONAL TAYLOR FARMS BLEND GARDEN SALAD MIX W/ROM 6/5# ND TAYLOR FARMS BLEND LETT/ROM 50/50 NOCLR 4/5# TAYLOR FARMS BLEND LETT/ROM 70/30 NOCOLR 4/5# TAYLOR FARMS BLEND LETT/ROM 80/20 4/5# TAYLOR FARMS LETTUCE SALAD MIX 4/5# Iceberg, Romaine products.
Potential Cyclospora contamination.
NHTSAAvride Inc. - ADS Software May Cause Unexpected Vehicle Movement
Avride Inc. - ADS Software May Cause Unexpected Vehicle Movement
Unexpected vehicle movement may increase the risk of a crash.
FDA FoodCross Valley Farms LETTUCE CHOP 4/5# Cross Valley Farms LETTUCE SHRED 1/4" 4/5# Cross Valley Farms LETTUCE SHRED 1/8" 4/5# Iceberg only products.
Cross Valley Farms LETTUCE CHOP 4/5# Cross Valley Farms LETTUCE SHRED 1/4" 4/5# Cross Valley Farms LETTUCE SHRED 1/8" 4/5# Iceberg only products.
Potential Cyclospora contamination.
FDA FoodHoneyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND SODIUM BENZOATE. MANUFACTURED FOR: HONEYVILLE, INC. RANCHO CUCAMONGA, CA 91730
Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND SODIUM BENZOATE. MANUFACTURED FOR: HONEYVILLE, INC. RANCHO CUCAMONGA, CA 91730
Undeclared Red #40.
FDA DevicesPhilips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
FDA FoodPEAK LETTUCE SALAD W/BAG 4/5# Iceberg, Carrots, Red Cabbage products.
PEAK LETTUCE SALAD W/BAG 4/5# Iceberg, Carrots, Red Cabbage products.
Potential Cyclospora contamination.
FDA DrugsSEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
FDA DevicesBIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Due to increase in false negative results
FDA DevicesProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.
FDA FoodMARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.
MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.
Potential Cyclospora contamination.
FDA DevicesSurgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
FDA DevicesCardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B
Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
FDA FoodPEAK LETTUCE SHRED 1/8" 4/5# Iceberg only products.
PEAK LETTUCE SHRED 1/8" 4/5# Iceberg only products.
Potential Cyclospora contamination.
FDA DevicesEndo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
FDA DevicesCardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43NEE13; 5) LAMINECTOMY PACK , Catalog Number: SNE43NEE13; 7) LAMINECTOMY PACK , Catalog Number: SNE5CLPB13; 8) PEDI SPINE R , Catalog Number: SNE69PSKR4; 9) SHUNT PACK , Catalog Number: SNE7CSHY15; 10) SHUNT PACK , Catalog Number: SNE7CSHY16; 11) ENS ORTHO FUSION POSTERIEURE 3, Catalog Number: SOP30ODSCL
Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE; 3) NEURO MAJOR 2 PACK , Catalog Number: SNE30CRJGY; 4) NEURO PACK , Catalog Number: SNE43NEE13; 5) LAMINECTOMY PACK , Catalog Number: SNE43NEE13; 7) LAMINECTOMY PACK , Catalog Number: SNE5CLPB13; 8) PEDI SPINE R , Catalog Number: SNE69PSKR4; 9) SHUNT PACK , Catalog Number: SNE7CSHY15; 10) SHUNT PACK , Catalog Number: SNE7CSHY16; 11) ENS ORTHO FUSION POSTERIEURE 3, Catalog Number: SOP30ODSCL
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
FDA DevicesGM Helix Implant, Endosseous Dental Implant Article No. 109.984
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
FDA DevicesDermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
FDA Devices60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used to administer fluids.
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used to administer fluids.
Products may not have received adequate sterilization processing.
FDA FoodAquafaba Powder, Vegan Replacement, NET WT. 4 oz (113g) and 12 0z (340g), Resealable stand-up matte foil pouch with zipper. UPC 99284 53095 and UPC 99284 30622
Aquafaba Powder, Vegan Replacement, NET WT. 4 oz (113g) and 12 0z (340g), Resealable stand-up matte foil pouch with zipper. UPC 99284 53095 and UPC 99284 30622
Undeclared Egg