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

11076–11100 of 27647

HighFDA (Devices)·Z-2701-2024·2024-08-28
Medline medical procedure kits recalled for dimensional variation
Medline is recalling medical procedure kits due to a slight dimensional variation that may cause fitting difficulties. No injuries or illnesses have been reported.
Product
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR,
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-2693-2024·2024-08-28
IBA Proton Therapy System PROTEUS 235 Collision Detection Malfunction
FDA recalls 19 units of the IBA Proton Therapy System PROTEUS 235 due to occasional failures in collision detection for the Forte Robotic Patient Positioning System affecting facilities across multiple US states and internationally.
Product
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2686-2024·2024-08-28
Diagnostic Test Kit May Produce False Results in Tuberculosis Drug Resistance Testing
The BD BACTEC MGIT 960 PZA Kit may intermittently produce falsely resistant results when testing TB susceptibility to pyrazinamide. This Class II recall affects 12,383 units distributed worldwide.
Product
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2711-2024·2024-08-28
Medline neuro procedure kits recalled for dimensional fitting variation
Medline is recalling 2,013 medical procedure kits due to a slight dimensional variation that may cause difficulty fitting into the outer canister. No injuries reported.
Product
Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c) NEURO, REF DYNJ902388L; d) NEURO SAS, REF DYNJ908566
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2662-2024·2024-08-28
Alcon recalls ClearCut ophthalmic knives due to sharpness issues
Alcon is recalling approximately 11,916 ClearCut SB Intrepid 2.2 ANG ophthalmic knives due to complaints about blade sharpness. The affected units were distributed nationwide and internationally.
Product
Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2705-2024·2024-08-28
Medline ENDO KIT procedure kits recalled for dimensional variation affecting fit
Medline is recalling 2,588 ENDO KIT medical procedure kits worldwide due to dimensional variation that may cause difficulty fitting into the outer canister.
Product
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2647-2024·2024-08-28
Alcon ophthalmic surgical knives recalled for sharpness and performance degradation
Alcon is recalling surgical instrument packs that include ClearCut and A-OK brand ophthalmic knives due to increasing complaints about sharpness loss. The affected knives could impact surgical precision during eye procedures.
Product
Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System. 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-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-2698-2024·2024-08-28
Medline Med-Soft Liners Recalled for Potential Fitting Difficulty
Medline Industries is recalling approximately 35,900 Med-Soft Liners due to a dimensional variation that could make them difficult to fit into the outer canister. No injuries have been reported.
Product
1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2688-2024·2024-08-28
Barricaid Annular Closure Impactor recalled due to missing welds
Intrinsic Therapeutics recalls 207 units of Barricaid Annular Closure Impactor devices nationwide due to manufacturing defects where at least two units are missing critical welds.
Product
Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2673-2024·2024-08-28
Alcon Ophthalmic Surgical Knives Recalled for Sharpness Defects
Alcon recalls TOTAL PLUS ophthalmic surgical knives due to sharpness defect complaints. The 3,197 affected units are distributed nationwide and internationally.
Product
Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 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-2682-2024·2024-08-28
BIOFIRE FILMARRAY Pneumonia Panel Recalled for Manufacturing Defect
BioFire Diagnostics is recalling 58 units of BIOFIRE FILMARRAY Pneumonia Panel due to a manufacturing defect that increases the risk of control failures and delayed test results.
Product
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2684-2024·2024-08-28
VITROS XT Chemistry Slides Recalled for Dust Contamination of Diagnostic Results
Ortho-Clinical Diagnostics is recalling 88,253 units of VITROS XT Chemistry ALB-TP Slides because they shed dust and debris during normal operation, potentially contaminating sodium test results and causing misdiagnosis.
Product
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated
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 (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 (Food)·F-1744-2024·2024-08-28
L&B Beautiful Morning Glory Muffins Recalled for Metal Contamination
Lunds Mitchell Rd LLC is recalling L&B Beautiful Morning Glory Muffins (Product #49025, Lot 301355) distributed in Minnesota due to potential metal contamination in the product.
Product
L&B Beautiful Morning Glory Muffins. Product #49025. 4 muffins per container. Net Wt 14 oz. UPC 18169-49025.
Category
Food
Distribution
1 state
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 (Devices)·Z-2685-2024·2024-08-28
Regard Kit Decanters Recalled for Defective Sterile Packaging
ROi CPS LLC is recalling 78 Regard Kits containing Microtek decanters due to pin holes and tears in sterile packaging that cannot be identified visually. Defective packaging could compromise the sterile barrier.
Product
Regard Kit containing the Microtek decanter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2651-2024·2024-08-28
Ophthalmic knives recalled for sharpness defects in ClearCut Safety Intrepid DB
Alcon is recalling 1,152 ClearCut Safety Intrepid DB 2.2 ophthalmic knives (Model 8065772265) due to complaint reports of sharpness defects.
Product
Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2667-2024·2024-08-28
Alcon recalls ophthalmic knives due to sharpness defects
Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives due to increased complaint reports related to blade sharpness. Healthcare providers should not use affected units pending further evaluation.
Product
Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2655-2024·2024-08-28
Alcon A-OK Ophthalmic Knife Recalled for Sharpness Defect
Alcon is recalling A-OK ophthalmic knives due to an increase in reports of sharpness defects. The affected knives are used in eye surgery and may not perform as intended.
Product
Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Description: Ophthalmic knife 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

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11076–11100 of 27647