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 the agency’s own highest classification or reported deaths or serious injuries, 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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1–25 of 27596

  • SevereFDA (Devices)·Z-0001-2027·2026-10-21

    Instrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic

    Instrumentation Laboratory is recalling 434 units of the HemoslL AcuStar HIT-lgG in vitro diagnostic due to potential for invalid calibration curves or negative mean bias of up to 47% with patient samples.

    Product
    HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0146-2027·2026-10-21

    SI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues

    SI-BONE, Inc. is recalling 100 units of iFuse TORQ Implant System screws because packaging seal integrity testing failed, preventing assurance of sterility.

    Product
    iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0136-2027·2026-10-21

    JenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation

    Jenavalve Technology Inc. is recalling 143 JenaValve Trilogy Delivery Catheters due to a defect that may prevent heart valve deployment.

    Product
    JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0160-2027·2026-10-21

    Beckman Coulter DxU 840m and 850m Iris Recalled for Check Valve Defect

    Beckman Coulter is recalling DxU 840m and 850m Iris analyzers because a check valve defect can cause fluid leaks, creating slip, chemical, and biohazard risks.

    Product
    DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0137-2027·2026-10-21

    Medtronic Recalls Grafton DBM Allografts Due to Donor Microbial Presence

    Medtronic is recalling 18 units of Grafton DBM and Grafton Plus DBM products because the donor tissue tested positive for Clostridium butyricum, posing a potential infection risk.

    Product
    Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0153-2027·2026-10-21

    Ethicon Recalls Silk Surgical Sutures Packaged with Alcohol-Based Fluid

    Ethicon is recalling 1,764 units of PERMA-HAND Silk sutures that were packaged with alcohol-based fluid. The fluid is not part of the product design and could cause surgical delays or treatment failure if used.

    Product
    PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0154-2027·2026-10-21

    Steris Recalls RAPICIDE PA High-Level Disinfectant Due to Pressure Hazard

    Steris Corporation is recalling 374 units of RAPICIDE PA Part A High-Level Disinfectant because a blocked vented cap may cause the bottle to swell and release vapor or liquid, posing an injury risk.

    Product
    RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0172-2027·2026-10-21

    Medline surgical kits recalled for non-conforming cannula components

    Medline is recalling 56 surgical convenience kits because the cannula components may leak or break during use.

    Product
    Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0155-2027·2026-10-21

    FDA recalls Steris RAPICIDE PA disinfectant

    Steris is recalling 11,806 units of its RAPICIDE PA high-level disinfectant because a blocked vented cap can cause the bottle to swell and release vapor or liquid, risking user injury.

    Product
    RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0176-2027·2026-10-21

    Medline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components

    Medline Industries is recalling 36,199 surgical convenience kits nationwide because cannula components do not meet ISO 80369-7 dimensional requirements, posing a risk of leaking or breaking during use.

    Product
    Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PACK, Medline Product number/SKU DYNJ85751; 4) OPEN HEART PACK, Medline…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0140-2027·2026-10-21

    BD Phoenix Panel NMIC-306 Recalled for Quality Control Failures

    Becton Dickinson is recalling 669,200 units of the BD Phoenix Panel NMIC-306 due to potential quality control failures with Klebsiella pneumoniae ATCC BAA-1705.

    Product
    BD Phoenix Panel NMIC-306. Catalog Number: 449292.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0141-2027·2026-10-21

    Cadwell IOMAX Cortical Module Recalled for Defective Circuit Board

    Cadwell Industries is recalling 23 IOMAX Cortical Modules because a defective circuit board may cause unintended electrical stimulation to patients.

    Product
    Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0134-2027·2026-10-21

    JenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation

    Jenavalve Technology Inc. is recalling 111 units of JenaValve Trilogy Delivery Catheters due to a defect that may prevent heart valve deployment.

    Product
    JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0002-2027·2026-10-21

    Instrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents

    Instrumentation Laboratory is recalling 1,414 units of HemoslL AcuStar HIT-lgG(PF-4) in vitro diagnostic reagents due to a potential for invalid calibration curves or negative mean bias of up to 47% with patient samples.

    Product
    HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0135-2027·2026-10-21

    JenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation

    Jenavalve Technology Inc. is recalling 108 units of the JenaValve Trilogy Delivery Catheter due to a defect that may prevent heart valve deployment.

    Product
    JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0138-2027·2026-10-21

    Medtronic Recalls Grafton DBM Products Due to Donor Microbial Presence

    Medtronic is recalling specific Grafton DBM and Grafton Plus DBM products because the donor tissue tested positive for Clostridium butyricum, posing a potential infection risk.

    Product
    Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0161-2027·2026-10-21

    Beckman Coulter IQ200 Hematology Analyzers Recalled for Check Valve Defect

    Beckman Coulter is recalling IQ200 SPRINT, SELECT, and ELITE hematology analyzers because a check valve defect may cause fluid leaks, creating slip, chemical, and biohazard risks.

    Product
    IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B48999, C10683
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2027·2026-10-21

    Medline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components

    Medline is recalling 193,374 surgical convenience kits nationwide because the cannula components do not meet ISO 80369-7 dimensional requirements and may leak or break during use.

    Product
    Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171AG; 3) MHC AV FISTULA, Medline product number/SKU DYNJ903705K; 4) PERIPHERAL VASC MAJR-LF, Medline product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2027·2026-10-21

    Medline Recalls Surgical Kits With Non-Conforming Cannula Components

    Medline Industries is recalling 1,900 surgical convenience kits because cannula components do not meet ISO 80369-7 standards and may leak or break during use.

    Product
    Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2027·2026-10-21

    Baxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk

    Baxter Healthcare is recalling Likorall Overhead Lifts because a motor shaft breakage combined with reduced safety system performance may cause the lift strap to lower quickly, posing a risk of patient injury.

    Product
    Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122005NA Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122006 Product Description…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2027·2026-10-21

    BD Phoenix Panel NMIC-312 recalled for classification error

    Becton Dickinson is recalling 553,625 BD Phoenix Panel NMIC-312 units nationwide because the CPO Ambler classification feature may misclassify Klebsiella pneumoniae.

    Product
    BD Phoenix Panel NMIC-312. Catalog Number: 449082.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2027·2026-10-21

    Medline Recalls Surgical Kits With Non-Conforming Cannula Components

    Medline Industries is recalling 8,374 surgical convenience kits nationwide because the cannula components do not meet ISO 80369-7 dimensional requirements and may leak or break during use.

    Product
    Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ0665837G; 3) AV FISTULA, Medline product number/SKU DYNJ900454C; 4) VEIN PACK SHD, Medline product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2027·2026-10-21

    Medline surgical kits recalled for non-conforming cannula components

    Medline is recalling 6,069 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements and may leak or break during use.

    Product
    Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-LF, Medline Product Number/SKU DYNJ0159820F; 4) AV FISTULA PACK, Medline Product Number/SKU…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0071-2027·2026-10-14

    Steris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect

    Steris is recalling VERIFY Biological/Integrator Challenge Packs because the spore population may be too low, potentially causing false results in steam sterilization monitoring.

    Product
    VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0086-2027·2026-10-14

    Medline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk

    Medline is recalling 1,824 bariatric rollators because the front wheel assembly may detach, posing a risk of falls and serious injury.

    Product
    Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWS
    Category
    Medical Device
    Distribution
    Distributed nationwide