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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1551–1575 of 39987

  • HighFDA (Devices)·Z-1538-2026·2026-03-18

    GEM Premier 5000 part 00055430008 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055430008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2026·2026-03-18

    IBA proton therapy system may not interrupt beam when gating fails

    Ion Beam Applications is recalling PROTEUS 235 proton therapy systems because a disabled interface means the safety system may not interrupt beam delivery if the external gating signal is lost.

    Product
    IBA Proton Therapy System - PROTEUS 235
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2026·2026-03-18

    Link Endo-Model plateau 15-0027/16 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/16 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/16;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2026·2026-03-18

    GEM Premier 5000 part 00055415005 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415005 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055415005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1525-2026·2026-03-18

    GEM Premier 5000 PAK part 00055360008 may eject during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 PAK part 00055360008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000 PAK; Part No. 00055360008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2026·2026-03-18

    GEM Premier 5000 part 00055430004 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055430004 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055430004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2026·2026-03-18

    Beckman Coulter DxC 700 AU analyzer may stop analyzing after errors

    Beckman Coulter is recalling DxC 700 AU analyzers because leaving the calibration monitor open beyond 15 minutes can trigger database errors that stop the system analyzing.

    Product
    DxC 700 AU, REF: B86444, B86446
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1519-2026·2026-03-18

    Link Endo-Model plateau 15-8521/11 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/11 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8521/11;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1534-2026·2026-03-18

    GEM Premier 5000 part 00055415008 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415008 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No. 00055415008.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2026·2026-03-18

    Link Endo-Model plateau 15-2836/11 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-2836/11 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-2836/11;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2026·2026-03-18

    Link Endo-Model plateau 15-0027/15 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/15 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/15;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1536-2026·2026-03-18

    GEM Premier 5000 part 00055415011 may eject cartridges during warm-up

    Instrumentation Laboratory is recalling GEM Premier 5000 part 00055415011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up causing cartridge ejection.

    Product
    GEM Premier 5000; Part No: 00055415011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2026·2026-03-18

    Exactech Ergo modular impactor handle may be missing its cross-pin

    Exactech is recalling the Equinoxe Ergo Modular Impactor Handle, model 321-09-05, because the impactor handle may be missing a cross-pin.

    Product
    Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1556-2026·2026-03-18

    Artelon FlexBand Twist anchors failed bacterial endotoxin testing

    International Life Sciences is recalling the Artelon FlexBand Twist .12, ref TW012, because the augmentation devices failed bacterial endotoxin testing.

    Product
    Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2026·2026-03-18

    GEM Premier 5000 parts 00055445010 and 00055445011 may eject cartridges

    Instrumentation Laboratory is recalling GEM Premier 5000 parts 00055445010 and 00055445011 after confirmed complaints of Process Control Solution Not Detected errors during warm-up.

    Product
    GEM Premier 5000; Part No. 00055445010 & 00055445011.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2026·2026-03-18

    Exactech Equinoxe core instrument kits may have handles missing cross-pins

    Exactech is recalling the Equinoxe Core Instrument Kit, model KIT-311X, because the impactor handle may be missing a cross-pin.

    Product
    Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1563-2026·2026-03-18

    Medline Medcrest surgical gowns may delaminate prematurely after recommended laundering

    Medline is recalling Medcrest surgical gowns because the fabric may delaminate prematurely when the included laundering instructions are followed.

    Product
    Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDTGXC4JXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XL MDTGXC4JXXL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,XX MDTGXP4JL DBD-GOWN,SURG,XALT,L4,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1495-2026·2026-03-18

    Zinc paste bandage labeling omitted castor oil and calamine ingredients

    KOB GmbH is recalling Medline Unna-Z Stretch Zinc Paste Bandage because of a labeling error: the ingredients list did not include castor oil or calamine.

    Product
    MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1496-2026·2026-03-18

    BD syringe batch may contain Luer Slip instead of Luer Lok

    Becton Dickinson is recalling one lot of 10 mL Non-Sterile BD Luer-Lok Tip Syringes because some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.

    Product
    10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1560-2026·2026-03-18

    Clearest Strep-A cassette test recalled because it lacks FDA clearance

    Altruan GmbH is recalling the Clearest Strep-A Cassette Test, used to detect group A streptococci in throat swab samples, because the product is not cleared by the FDA.

    Product
    Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1562-2026·2026-03-18

    Chest drainage unit instructions updated to specify adult patient population

    Medline is recalling three surgical kits containing Cardinal Health Aqua-Seal Chest Drainage Units because the instructions for use have been updated to clarify the target patient population as adults.

    Product
    Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1561-2026·2026-03-18

    Bisaf Strep A self-test recalled because it lacks FDA clearance

    Altruan GmbH is recalling the Bisaf Strep A Self-Test, used to detect group A streptococcal antigens in throat swabs, because the product is not cleared by the FDA.

    Product
    Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1550-2026·2026-03-18

    Medartis APTUS TriLock screw lots mixed 2.5 mm and 2.8 mm

    Medartis is recalling one lot of the APTUS 2.8 TriLock Screw 16 mm because of a mix up between specified lots of 2.5 mm and 2.8 mm outer diameter screws.

    Product
    Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1559-2026·2026-03-18

    Wondfo Streptococcal A self-test recalled because it lacks FDA clearance

    Altruan GmbH is recalling the Wondfo Streptococcal A At-Home Self-Test, used for group A beta-hemolytic streptococcal infection, because the product is not cleared by the FDA.

    Product
    Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1549-2026·2026-03-18

    Medartis APTUS 2.5 TriLock screw lots mixed with 2.8 mm

    Medartis is recalling one lot of the APTUS 2.5 TriLock Screw 16 mm because of a mix up between specified lots of 2.5 mm and 2.8 mm outer diameter screws.

    Product
    Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot.
    Category
    Medical Device
    Distribution
    Distributed nationwide