Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

11101–11125 of 27647

HighFDA (Devices)·Z-2648-2024·2024-08-28
Alcon ophthalmic surgical knives recalled for blade sharpness defects
Alcon is recalling specific ophthalmic surgical knives (ClearCut and A-OK models) from its Custom Pak system due to blade sharpness complaints affecting 384,851 units distributed nationwide and internationally.
Product
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2677-2024·2024-08-28
Ophthalmic Surgical Knives Recalled Due to Sharpness Complaint Reports
Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic surgical knives (Model 8065752438) due to increased complaint reports about sharpness.
Product
Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1741-2024·2024-08-28
KALO Chocolate Cake Gluten Free recalled for undeclared soy allergen
KALO All Natural Chocolate Cake Gluten Free (84 slices) is recalled due to undeclared soy. Carrot cake slices were accidentally packaged in chocolate cake containers.
Product
All Natural KALO Chocolate Cake Gluten Free, UPC 8 53407 00418 4, Distributed by: Kalo Foods, LLC Stokesdale, NC 27357
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-2645-2024·2024-08-28
ClearCut S Safety Sideport Knife Recalled for Decreased Sharpness
Alcon Research LLC is recalling ClearCut S Safety Sideport Knife ophthalmic surgical instruments due to reports of decreased sharpness. Affected units may not perform as intended during eye surgery.
Product
Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2653-2024·2024-08-28
Ophthalmic Surgical Knives Recalled for Potential Sharpness Issues
Alcon is recalling specific ophthalmic knives following an increase in complaint reports related to sharpness. These surgical instruments are used in eye procedures.
Product
Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2669-2024·2024-08-28
Alcon Ophthalmic Surgical Knives Recalled Over Reported Sharpness Issues
Alcon is recalling 11,676 ophthalmic surgical knives due to increased reports of sharpness defects. Affected units were distributed nationwide and internationally.
Product
Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2668-2024·2024-08-28
Ophthalmic Knives Recalled for Sharpness Defects
Alcon recalls A-OK ophthalmic knives for sharpness defects. Approximately 30,268 units distributed nationwide and internationally are affected.
Product
Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2712-2024·2024-08-28
Medline Medical Procedure Kits Recalled for Dimensional Variation Affecting Fit
Medline is recalling 964 units of multiple medical procedure kits due to slight dimensional variations that may cause difficulty fitting components into the outer canister. No injuries or illnesses have been reported.
Product
Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d) GYN LAPAROSCOPY, REF DYNJ905509F; e) GYN LAPAROSCOPY II, REF DYNJS2030F; f) LAP ROBOTIC, REF DYNJ902384K; g) LAPAROSC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2675-2024·2024-08-28
Ophthalmic surgical knives recalled due to reported sharpness defects
Alcon is recalling specific ophthalmic surgical knives due to reported sharpness defects. The recall affects 3,791 units distributed nationwide and internationally.
Product
Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2644-2024·2024-08-28
Medical Device Recall: Ventana Anti-CD10 Antibody May Produce False Positive Results
Ventana Medical Systems recalls its anti-CD10 (SP67) rabbit monoclonal antibody due to potential high background and off-target staining that could produce false positive test results. Approximately 22,839 kits distributed worldwide are affected.
Product
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2672-2024·2024-08-28
FDA Recalls Alcon Ophthalmic Knives for Decreased Blade Sharpness
Alcon is recalling 1,061 ophthalmic surgical knives due to reports of decreased sharpness. The affected instruments are used in eye surgery procedures and may not perform as intended.
Product
Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2680-2024·2024-08-28
Alcon Ophthalmic Knives Recalled Due to Sharpness Defect Complaint Increase
Alcon is recalling ClearCut and A-OK Corneal/Scleral ophthalmic knives due to increased complaints about sharpness. The recall affects 6,972 units distributed nationwide and internationally.
Product
Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2650-2024·2024-08-28
Ophthalmic Knives Recalled Due to Complaints About Reduced Sharpness
Alcon is recalling ophthalmic knives for increased complaints of reduced sharpness. These surgical instruments require consistent blade sharpness for surgical precision in eye procedures.
Product
Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2670-2024·2024-08-28
Alcon Recalls ClearCut Ophthalmic Knives Due to Reduced Sharpness
Alcon is recalling 15,222 units of ClearCut Slit and A-OK ophthalmic knives due to reports of reduced sharpness. The devices are distributed nationwide and internationally across 45+ countries.
Product
Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2706-2024·2024-08-28
Medline procedure kit has dimensional variation affecting canister fitting
Medline is recalling 3400 units of ENDO medical procedure kits due to a dimensional variation that may cause difficulty fitting the kit into its outer canister.
Product
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2683-2024·2024-08-28
FDA Recalls BioFire Pneumonia Diagnostic Test Kits for Control Failures
BioFire Diagnostics recalls BIOFIRE FILMARRAY Pneumonia Panel plus test kits due to manufacturing defects that could lead to control failures and delayed test results. The affected kits were distributed in multiple US states and countries worldwide.
Product
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2660-2024·2024-08-28
Ophthalmic surgical knives recalled for increased reports of dulled blades
Alcon recalls specific ClearCut and A-OK ophthalmic surgical knives after reports of reduced blade sharpness. About 7,598 units were distributed nationwide and internationally.
Product
Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0636-2024·2024-08-28
Lidocaine HCl Injection Recall Due to Lack of Sterility Assurance
Fagron Compounding Services is recalling Lidocaine HCl Injection due to lack of assurance of sterility. Four lot numbers distributed nationwide are affected with expiration date 10/14/2024.
Product
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1742-2024·2024-08-28
Shahzada Cinnamon Powder Recalled for Elevated Lead Content
Shahzada brand Cinnamon Powder is being recalled due to elevated lead content detected in the product. The affected 7 oz packets were distributed in New York, Massachusetts, New Jersey, and Connecticut.
Product
Shahzada brand Pulses and Spices; Cinnamon Powder; 7 oz (200g); packaged in clear plastic zip-top bags
Category
Food
Distribution
4 states
HighFDA (Drugs)·D-0637-2024·2024-08-28
Testosterone Gel Recalled by Teva for Excessive Potency
Teva Pharmaceuticals recalls 7,080 packets of Testosterone Gel nationwide due to higher-than-labeled potency. Patients using the recalled product may receive unintended overdoses.
Product
TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2656-2024·2024-08-28
Ophthalmic Surgical Knives Recalled Due to Sharpness Issues
Alcon Research LLC is recalling certain ophthalmic knives (20 Gauge V-Lance model) due to complaints about sharpness. The affected units may not function properly during eye surgery.
Product
Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2643-2024·2024-08-28
Transfer Device REF 2008S Sterile Barrier Packaging Defect Recall
Microtek Medical's Transfer Device REF 2008S is being recalled due to pin holes and tears in the sterile packaging barrier identified during testing. These defects compromise sterility and could allow contamination.
Product
Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2654-2024·2024-08-28
ClearCut Ophthalmic Knives Recalled for Sharpness Defect
Alcon is recalling 18,726 ClearCut ophthalmic knives worldwide due to reports of inadequate sharpness. The defect could compromise surgical precision during eye surgery.
Product
Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2674-2024·2024-08-28
Alcon ophthalmic surgical knives recalled for sharpness defects
Alcon Research LLC recalls ClearCut and A-OK ophthalmic surgical knives due to increased reports of sharpness issues that may affect surgical performance.
Product
Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2659-2024·2024-08-28
Ophthalmic Surgical Knives Recalled for Reduced Sharpness in Eye Surgery
Alcon Research LLC is recalling 2,520 CLEARCUT HP2 DB ophthalmic knives due to increased reports of reduced sharpness. The affected lot 164RY1 was distributed nationwide and internationally.
Product
Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide

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11101–11125 of 27647