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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28251–28275 of 40357

  • HighFDA (Devices)·Z-0655-2017·2016-11-30

    Hologic Recalls SURESOUND22 Uterine Sounds Due to Sterile Barrier Breach

    Hologic is recalling SURESOUND22 uterine sound multipacks because a breach in the sterile barrier compromises product sterility.

    Product
    SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2017·2016-11-30

    Merit Medical Recalls Manifold Kits Due to Compromised Sterile Barrier

    Merit Medical Systems is recalling 40 Manifold Kits (Catalog No. K09-11867AP) because the sterile barrier is compromised, posing a risk of infection.

    Product
    Manifold Kit. Catalog Number K09-11867AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0634-2017·2016-11-30

    Merit Medical Recalls Pressure Monitoring Kits Due to Sterile Barrier Compromise

    Merit Medical Systems is voluntarily recalling 130 MeriTrans Pressure Monitoring Kits because a compromised sterile barrier may affect product sterility.

    Product
    Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2017·2016-11-30

    DePuy ACTIS Flex Reamers Recalled Due to Breakage Risk

    DePuy Orthopaedics is voluntarily recalling ACTIS Flex Reamers because the instruments may break and leave pieces in patients.

    Product
    ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0622-2017·2016-11-30

    Toshiba Aquilion Prime CT System Recalled for Cooling Oil Leak Risk

    Toshiba American Medical Systems is recalling Aquilion Prime CT systems because cooling oil in the x-ray tube heat exchanger may leak during operation.

    Product
    Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2017·2016-11-30

    Philips CT Scanner Recall Due to Tabletop Movement Failure

    Philips is recalling 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.

    Product
    Philips Healthcare System X-ray Tomography Computed :
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2017·2016-11-30

    Merit Medical Procedure Kits Recalled for Compromised Sterile Barrier

    Merit Medical Systems is voluntarily recalling specific Procedure Kits due to a compromised sterile barrier, which may affect the sterility of the contents.

    Product
    Waste Management Kit. Catalog Number K10-04381AP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2017·2016-11-30

    Siemens Dimension Vista Chemistry 1 Calibrator Recall for Low Calcium Recovery

    Siemens is recalling Dimension Vista Chemistry 1 Calibrators (lots 5GM081 and 5GM082) because they may cause discrepant low calcium recovery in quality control and patient samples.

    Product
    Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0651-2017·2016-11-30

    Bausch + Lomb Recalls PeroxiClear Peroxide Solution for Excess Residuals

    Bausch + Lomb is recalling PeroxiClear Peroxide Solution because the product was found to contain excess residual levels of hydrogen peroxide.

    Product
    PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2017·2016-11-30

    DiaSorin Recalls LIAISON Estradiol II Gen Assay Due to Cross-Reactivity

    DiaSorin is recalling the LIAISON Estradiol II Gen assay because it may produce inaccurate results for patients treated with fulvestrant.

    Product
    LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0376-2017·2016-11-30

    Philips CT Scanner Recall Due to Potential Tabletop Movement Failure

    Philips is recalling 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.

    Product
    Philips Healthcare System X-ray Tomography Computed :
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0623-2017·2016-11-30

    Greatbatch Stiffer Coaxial Micro-Introducer Recalled for Detaching Luer

    Greatbatch Medical is recalling Stiffer Coaxial Micro-Introducers because a rotating luer detached from the dilator hub during use.

    Product
    Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR.…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0614-2017·2016-11-30

    Merge Healthcare Recalls RadSuite Software Due to Image Display Malfunction

    Merge Healthcare is recalling RadSuite software versions 8.30.7.8 through 8.31 because images may not appear readable, potentially delaying care or causing patient re-exposure to radiation.

    Product
    Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0629-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling 21 units of SKYLINE Anterior Cervical Plate System Constrained Self-Tapping Screws because Variable Ti screws may have been incorrectly packaged with them.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0648-2017·2016-11-30

    Beckman Coulter Recalls AQUIOS Lyse Reagent Kit for Increased Flags

    Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may cause increased notifications and flags on AQUIOS CL systems, potentially delaying test results.

    Product
    AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0644-2017·2016-11-30

    Synthes 2.5 mm Reaming Rods Recalled for Delaminating Peel Pouches

    Synthes (USA) Products LLC is recalling 2,157 sterile 2.5 mm reaming rods because their peel pouches are delaminating.

    Product
    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0630-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws

    DePuy Spine is recalling 12 SKYLINE Anterior Cervical Plate System screws because they may have been packaged with the wrong screw type.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0626-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0642-2017·2016-11-30

    Synthes Extraction Hook Recall Due to Peel Pouch Delamination

    Synthes (USA) Products LLC is recalling 114 sterile extraction hooks because their peel pouches are delaminating, potentially compromising sterility.

    Product
    Extraction Hook - Sterile for TI Cannulated Nails
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0627-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0656-2017·2016-11-30

    Synthes Flexible Shaft Orthopedic Surgical Instrument Recalled for Non-Conforming Material

    Synthes (USA) Products LLC is recalling 198 units of Flexible Shaft orthopedic surgical instruments because non-conforming material was used in their manufacture.

    Product
    Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0643-2017·2016-11-30

    Synthes Recalls 2.5 mm Calibrated Reaming Rods Due to Pouch Delamination

    Synthes (USA) Products LLC is recalling 260 sterile 2.5 mm TI Calibrated Reaming Rods because their peel pouches are delaminating.

    Product
    2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0624-2017·2016-11-30

    DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws

    DePuy Spine is recalling 9 units of SKYLINE Variable Self-Drilling Screws because they may have been packaged with Constrained Ti screws.

    Product
    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic…
    Category
    Medical Device
    Distribution
    15 states