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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6901–6925 of 39968

  • HighFDA (Devices)·Z-2138-2024·2024-06-19

    EVD Catheter Sterile Packaging Defect Recall for Intracranial Drainage

    Integra LifeSciences is recalling CODMAN BACTISEAL EVD catheters due to external packaging seal defects that may compromise sterility. The recall affects 59 units distributed internationally.

    Product
    CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2024·2024-06-19

    OMTech Desktop Laser Engraver recalled for missing safety interlocks

    Rygel Advanced Machines recalls OMTech Desktop Laser Engravers due to missing safety interlocks and labeling. The devices lack required redundant interlocks and certification labels that prevent accidental laser exposure.

    Product
    OMTech Desktop Laser Engraver
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2031-2024·2024-06-19

    Streptococcal A Rapid Test Kits Recalled for Unauthorized Distribution

    Wondfo USA has recalled 170,000 units of Clarity Strep A Rapid Test kits due to unauthorized distribution for at-home use, non-prescription use, over-the-counter use, and direct-to-consumer sales. The recall affects test kits distributed nationwide.

    Product
    Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2035-2024·2024-06-19

    NEOMED Pharmacy Syringes recalled due to missing expiration dates

    Avanos Medical is recalling NEOMED Pharmacy Syringes because expiration dates were not printed on the outer shipping labels. Approximately 37,476 cases of various syringe sizes were distributed worldwide.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product Code BA-S05EO; b. 12mL Oral Syringe Amber NonSterile, Product Code BA-S12EO; c. 1mL Oral Syringe Amber NonSterile, Product Code BA-S1EO; d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2032-2024·2024-06-19

    Streptococcal A Rapid Test Kits Recalled for Unauthorized At-Home Distribution

    Wondfo USA recalls Areta Strep A test kits (Lot E03920802) distributed for unauthorized at-home and over-the-counter use. The recall affects 75,000 units distributed nationwide.

    Product
    Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2037-2024·2024-06-19

    NEOMED Oral Syringes Recalled Over Missing Expiration Dates on Labels

    Avanos Medical is recalling NEOMED oral syringes because expiration dates were not printed on outer shipping labels, allowing expired units to reach customers.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code BC-S05EO; b. 12mL Oral Syringe Orange NonSterile, Product Code BC-S12EO; c. 1mL Oral Syringe Orange NonSterile, Product Code BC-S1EO;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2143-2024·2024-06-19

    Darby Dental Prophylaxis Paste Mislabeled with Incorrect Part Number

    Young Dental Manufacturing is recalling 534 units of Darby Prophylaxis Paste with 1.23% Fluoride Ion (Lot 248607) due to incorrect part number labeling. The product was labeled as part number 045032 instead of the correct 040032.

    Product
    Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2132-2024·2024-06-19

    Medical device nerve block needles incorrectly labeled as DEHP-free

    Stimuplex A nerve block needles labeled as DEHP-free contain trace amounts of DEHP in the adhesive. B Braun is recalling approximately 1.78 million units distributed in the US and Canada.

    Product
    Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2030-2024·2024-06-19

    Strep A Rapid Test Kits Recalled for Unauthorized Distribution

    Wondfo USA is recalling approximately 1.2 million Preview Strep A rapid test kits (Part Numbers PRE-STA-25 and PRE-STA-A-10) that were distributed for at-home and direct-to-consumer use. The device is intended for professional channels only.

    Product
    Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2036-2024·2024-06-19

    NEOMED nonsterile pharmacy syringes recalled for missing expiration dates on labels

    Avanos Medical recalls NEOMED nonsterile pharmacy syringes because expiration dates were not printed on outer shipping labels, resulting in expired products being distributed.

    Product
    NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Blue NonSterile, Product Code BB-S05EO; b. 12mL Oral Syringe Blue NonSterile, Product Code BB-S12EO; c. 1mL Oral Syringe Blue NonSterile, Product Code BB-S1EO; d. 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1920-2024·2024-06-12

    Pediatric Patient Return Electrode Recalled for Reported Patient Burns

    Megadyne Medical Products is recalling its MEGA SOFT Pediatric Patient Return Electrode due to reports of patient burns during electrosurgical use. Approximately 1,270 units distributed worldwide are affected.

    Product
    MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1880-2024·2024-06-12

    Arrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect

    The FDA recalled 3,138 Arrow Ultra 8 intra-aortic balloon catheter kits globally due to potential balloon inflation failure and helium pathway damage that could compromise critical cardiac support.

    Product
    Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1879-2024·2024-06-12

    Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction

    Arrow International is recalling its UltraFlex Intra-Aortic Balloon Catheter Kit because of infrequent device malfunction that could lead to serious health consequences. 44,807 units are affected worldwide.

    Product
    Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1878-2024·2024-06-12

    Intra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects

    Arrow International is recalling intra-aortic balloon catheter kits due to potential inflation failure, catheter damage, and helium loss that could cause serious health consequences.

    Product
    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1877-2024·2024-06-12

    Sevoflurane Vaporizer Component Recall Due to Hydrogen Fluoride Degradation

    Getinge's sevoflurane vaporizer component may degrade into hydrogen fluoride, posing inhalation and skin exposure risks to healthcare workers and patients. The FDA Class I recall affects 120 units distributed across six U.S. states.

    Product
    Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1937-2024·2024-06-12

    Medline Disposable Syringes Recalled for Inaccurate Volume Delivery

    Medline is recalling 25.2 million Luer Lock disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity. The inaccuracy may pose a risk to patient health.

    Product
    MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2024·2024-06-12

    LOSPA Patella Knee Component Recalled for Unsupported Expiration Date

    CORENTEC's LOSPA Patella Component knee implants are recalled due to an unsupported 10-year expiration date. Thirty-five units were distributed nationwide.

    Product
    LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1949-2024·2024-06-12

    Medical device recall: HA FlexTrak patient transport trolley oil leak hazard

    Philips is recalling the HA FlexTrak patient transport trolley due to potential oil leaks from the hydraulic system that create slipping and falling hazards. Approximately 100 units have been distributed worldwide.

    Product
    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2024·2024-06-12

    Philips Tempus LS-Manual Defibrillator may malfunction from electrical interference

    Simultaneous ECG measurements with multiple devices can cause electrical interference that may prevent this defibrillator from functioning properly. The recall affects 1,745 units distributed nationwide.

    Product
    Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1941-2024·2024-06-12

    Synchro2 Guidewires: PTFE coating damage from improper backloading technique

    Stryker Neurovascular is recalling certain lots of Synchro2 Guidewires due to PTFE coating damage caused by backloading through an introducer accessory with manufacturing variations. Affected users should discontinue the backloading technique.

    Product
    The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewires are compatible with existing microcatheters used in common procedures such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2024·2024-06-12

    Medical device trolley recalled due to oil leak causing slipping hazard

    Philips HA FlexTrak II patient transport trolleys may leak hydraulic oil onto the floor when pressed, creating a slip and fall hazard. About 590 units are affected worldwide.

    Product
    HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1984-2024·2024-06-12

    Vascular graft separation reported in ADVANTA VXT medical devices

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Approximately 53,308 units have been affected worldwide.

    Product
    ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2024·2024-06-12

    FDA Recalls Atrium Medical Vascular Graft for Slider Separation Defect

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of the slider rod separating from the swivel core, which could impair proper device function.

    Product
    ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2024·2024-06-12

    Vascular graft component separation reported in ADVANTA VXT devices

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. No injuries have been reported.

    Product
    ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2024·2024-06-12

    Vascular graft separation issue prompts FDA recall of Atrium Medical ADVANTA VXT units

    Atrium Medical Corporation is recalling its ADVANTA VXT vascular grafts due to complaints of swivel rod separation from the swivel core, which could affect device function and patient safety.

    Product
    ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide