The Recall Desk

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.

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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

5526–5550 of 13512

  • HighFDA (Devices)·Z-2649-2024·2024-08-28

    Alcon ClearCut S Ophthalmic Knives Recalled for Sharpness Complaints

    Alcon is recalling ClearCut S and A-OK ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 5,039 units were distributed nationwide and internationally.

    Product
    Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2679-2024·2024-08-28

    Alcon Ophthalmic Surgical Knives Recalled for Inadequate Sharpness

    Alcon is recalling 4,481 units of ClearCut and A-OK brand ophthalmic surgical knives due to complaint reports of inadequate sharpness. These instruments are used in eye surgery and may not perform as intended.

    Product
    Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A 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-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-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-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 (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-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-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-2658-2024·2024-08-28

    Alcon ClearCut and A-OK Ophthalmic Knives Recalled for Reduced Sharpness

    Alcon is recalling ClearCut Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives due to reports of reduced blade sharpness. The recall affects 6,020 units distributed in the United States and internationally.

    Product
    Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2689-2024·2024-08-28

    Disposable 5 Lead Cable System May Contain Non-Approved ECG Leads

    Stryker Sustainability Solutions is recalling disposable 5 lead cable systems that may contain non-approved ECG leads which were improperly reprocessed. The wrong components may cause devices to malfunction.

    Product
    Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • ModerateFDA (Devices)·Z-2700-2024·2024-08-28

    Medline Anesthesia Circuit Kits Recalled for Dimensional Variation

    Medline is recalling three models of anesthesia circuit kits due to slight dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 1920 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2639-2024·2024-08-28

    C-Flow Bag Decanter Packaging Defects Prompt Sterile Barrier Recall

    Microtek Medical Inc. recalls C-Flow Bag Decanters (10,366 cases) due to pin holes and tears in sterile barrier packaging discovered during quality testing. The defects could allow bacterial contamination.

    Product
    C-Flow Bag Decanter, REF 2000S. 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
  • ModerateFDA (Devices)·Z-2704-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Canister Fitting Issues

    Medline is recalling 22,891 medical procedure kits because of a slight dimensional variation that may cause difficulty fitting into the outer canister.

    Product
    Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2709-2024·2024-08-28

    Medline medical procedure kits recalled due to dimensional variation

    Medline Industries is recalling 1,700 medical procedure kits due to a dimensional variation that may cause fitting difficulty into the outer canister. The affected kits were distributed in the US and internationally.

    Product
    Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2702-2024·2024-08-28

    Medline Dental Procedure Kits Recalled Due to Dimensional Variation

    Medline Industries is recalling certain dental procedure kits due to dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 99 units distributed worldwide.

    Product
    Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2707-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Dimensional Variation

    Medline Industries recalled 3,539 medical procedure kits due to a dimensional variation that may prevent proper fitting into their outer storage canister. The FDA classified this as a Class II recall.

    Product
    Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2708-2024·2024-08-28

    Medline Medical Procedure Kits Recalled for Dimensional Variation in Canister Fitting

    Medline Industries is recalling 75,098 medical procedure kits due to slight dimensional variations that may cause difficulty fitting into their outer canisters. No injuries or illnesses have been reported.

    Product
    Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2697-2024·2024-08-28

    Medline Medical Soft Liner Recall Due to Dimensional Variation

    Medline Industries recalls 1.5L medical soft liners due to slight dimensional variations that may cause difficulty fitting into the outer canister. The recall affects 88,703 units distributed worldwide.

    Product
    1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2699-2024·2024-08-28

    Medical Device Liner Recalled for Dimensional Variation Affecting Fit

    Medline Industries has recalled 316,125 units of its MED-SOFT Single Liner with Solidifier due to a dimensional variation that may cause difficulty when inserting the product into the outer canister.

    Product
    1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2696-2024·2024-08-28

    Medline Soft Liner Dimensional Variation May Affect Outer Canister Fit

    Medline Industries is recalling 1500ML soft liners due to dimensional variations that may make fitting into the outer canister more difficult. No injuries have been reported.

    Product
    1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2691-2024·2024-08-28

    Clinical Chemistry Analyzer Software Issue Causes Delayed Results

    Beckman Coulter clinical chemistry analyzers have a software issue that delays diagnostic results after processing 250 racks. Affected units experience buffer errors and result delays.

    Product
    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2710-2024·2024-08-28

    Medline Procedure Kits Recalled Due to Dimensional Fitting Issues

    Medline is recalling 160 medical procedure kits due to a dimensional variation that may make them difficult to fit into their outer canister. No injuries have been reported.

    Product
    Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
    Category
    Medical Device
    Distribution
    Distributed nationwide