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

6326–6350 of 39844

HighFDA (Devices)·Z-2641-2024·2024-08-28
Bottle Decanter REF 2004S Recalled for Sterile Barrier Packaging Defects
Microtek Medical Inc. is recalling Bottle Decanter REF 2004S units due to pin holes and tears found in the sterile barrier packaging during testing. Compromised packaging could allow contamination of the medical device.
Product
Bottle Decanter, REF 2004S. 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-2678-2024·2024-08-28
Alcon ophthalmic surgical knives recalled for sharpness defects
Alcon is recalling ClearCut and A-OK ophthalmic surgical knives due to sharpness complaints. The defect affects 1,057 units distributed nationwide and internationally.
Product
Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2716-2024·2024-08-28
Philips Allura Xper Interventional Fluoroscopy Systems Recalled for Incorrect Bolt
Philips Allura Xper systems contain an incorrect half-threaded bolt in LTE kits instead of the required full-threaded bolt. Six units distributed worldwide have been affected.
Product
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
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-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-2671-2024·2024-08-28
Ophthalmic Surgical Knives Recalled Due to Sharpness Defect
Alcon is recalling 7,713 units of ClearCut and A-OK ophthalmic surgical knives due to reports of decreased sharpness. The defect may compromise surgical performance during eye procedures.
Product
Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A 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-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
HighFDA (Devices)·Z-2665-2024·2024-08-28
Ophthalmic knives recalled for insufficient sharpness in surgical instruments
Alcon is recalling specific ophthalmic knives due to an increase in complaints regarding insufficient sharpness. Affected units may not perform as intended during surgical procedures.
Product
Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2676-2024·2024-08-28
Ophthalmic surgical knives recalled for blade sharpness defect
Alcon Research LLC is recalling 7,108 ClearCut and A-OK ophthalmic surgical knives due to increased complaint reports about blade sharpness. The affected knives were distributed nationwide and internationally.
Product
Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2640-2024·2024-08-28
Bag Decanter II Medical Device Recalled for Sterile Packaging Defects
Microtek Medical Inc. is recalling Bag Decanter II medical devices due to pinholes and tears identified in the sterile packaging film during quality testing, which could compromise product sterility.
Product
Bag Decanter II, REF 2002S. 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-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-2661-2024·2024-08-28
Alcon ophthalmic surgical knives recalled for sharpness defects
Alcon is recalling ophthalmic surgical knives (model 8065990002) due to increased complaint reports regarding sharpness. Approximately 9,384 units have been distributed domestically and internationally.
Product
Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2666-2024·2024-08-28
Alcon ophthalmic surgical knives recalled for sharpness defect
Alcon is recalling 145,248 ophthalmic knives (CLEARCUT SATINSLIT model 8065992745) due to increased complaint reports of inadequate sharpness. The surgical instruments were distributed nationwide and internationally.
Product
Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2652-2024·2024-08-28
Alcon Ophthalmic Surgical Knives Recalled for Inadequate Sharpness Defect
Alcon is recalling specific ophthalmic knives due to reports of inadequate sharpness. The affected instruments may not function as intended during surgical procedures.
Product
Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
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 (Devices)·Z-2703-2024·2024-08-28
Medline medical procedure kits recalled for dimensional variation affecting canister fit
Medline Industries recalled 6,998 medical procedure kits worldwide due to slight dimensional variations that may cause difficulty fitting into outer canisters. The Class II recall affects multiple procedure kit types distributed in the US and internationally.
Product
Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PACK,BRONCHOSCOPY, REF DYNJ65475B; g) PACK,HEAD AND NECK, REF
Category
Medical Device
Distribution
Distributed nationwide
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-2646-2024·2024-08-28
Ophthalmic Surgical Knives Recalled by Alcon Due to Sharpness Defects
Alcon is recalling 3,721 units of its 25GA Valved Entry System ophthalmic knives due to complaint reports about sharpness. The devices were distributed nationwide and internationally to 50+ countries.
Product
Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry System 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-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-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 (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

How to read this listing

Filters

6326–6350 of 39844