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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24151–24175 of 40299

  • ModerateFDA (Devices)·Z-1534-2018·2018-05-02

    Ethicon Recalls Evicel Fibrin Sealant Accessory Tips Due to Distribution Error

    Ethicon is recalling Evicel Accessory Device 45 cm Flexible Tips because products labeled for foreign distribution may have been distributed in the US.

    Product
    Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1526-2018·2018-05-02

    Stryker Recalls 18 Hinge Coupling Units Due to Packaging Error

    Stryker GmbH is recalling 18 Hinge Coupling Hoffmann LRF units because connecting nuts were incorrectly packed in hinge coupling packaging.

    Product
    Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1499-2018·2018-05-02

    Diagnostic Hybrids Recalls MicroVue SC5b-9 Plus EIA Kits Due to Bacterial Contamination

    Diagnostic Hybrids, Inc. is recalling 72 MicroVue SC5b-9 Plus EIA kits because a component was found to contain bacterial contamination.

    Product
    MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1512-2018·2018-05-02

    Howmedica Recalls Six Knee Prosthesis Units Due to Incorrect Size Labeling

    Howmedica Osteonics Corp. is recalling six sterile knee prosthesis units because the implant size may not match the box label.

    Product
    Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1529-2018·2018-05-02

    Accelerate PhenoTest BC kit recalled for false positive results

    Accelerate Diagnostics is recalling 95 PhenoTest BC kits because they may produce false positive results for Staphylococcus aureus.

    Product
    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1519-2018·2018-05-02

    Roche Acetaminophen Assay Method Sheets Missing Interference Statement

    Roche Diagnostics is recalling Acetaminophen assay method sheets for COBAS INTEGRA and MODULAR ANALYTICS systems because they omit a statement regarding potential interference from gammopathy.

    Product
    Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1521-2018·2018-05-02

    Cook Inc. Recalls Advance 35LP Balloon Catheters Due to Labeling Error

    Cook Inc. is recalling 40 Advance 35LP Low-Profile PTA Balloon Dilatation Catheters because some units were packaged with incorrect size labels.

    Product
    Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1474-2018·2018-05-02

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterile Packaging Seal Failure

    Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because of a potential failure of the sterile packaging seal.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1511-2018·2018-05-02

    Synthes Flex Arm Recalled for Potential Connection Failure

    Synthes, Inc. is recalling 84 Flex Arm units because the quick connect feature may fail to connect to mating parts.

    Product
    Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1361-2018·2018-05-02

    Crimson Trace Laser Sights Recalled for Exceeding Power Output Limits

    Crimson Trace is recalling 184,390 laser sights for firearms because some units exceeded the 5 mW power output limit.

    Product
    Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1486-2018·2018-05-02

    Siemens ADVIA Centaur CA 125II Assay Recalled for Over-Recovery

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 125II Assay kits because some patient samples may exhibit over-recovery outside the provided data.

    Product
    ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1462-2018·2018-05-02

    Howmedica Triathlon Revision Knee Implants Recalled for Sizing Errors

    Howmedica Osteonics Corp. is recalling 77 Triathlon Revision Knee implants because customers may receive the incorrect size from what is labeled on the box.

    Product
    Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1498-2018·2018-05-02

    Diagnostic Hybrids Recalls MicroVue SC5b-9 Plus EIA Kits Due to Bacterial Contamination

    Diagnostic Hybrids, Inc. is recalling 107 MicroVue SC5b-9 Plus EIA kits because a component was found to contain bacterial contamination.

    Product
    MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1473-2018·2018-05-02

    Zimmer Biomet Recalls Guide Wires Due to Sterile Packaging Seal Failure

    Zimmer Biomet is recalling Smooth Guide Wire Bullet Tip products because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1485-2018·2018-05-02

    Keystone Dental Recalls Genesis Surgical Cassettes Due to Burr Wobble

    Keystone Dental Inc is recalling 19 Genesis Surgical Cassettes because extra-large grommets cause dental burrs to wobble.

    Product
    Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1530-2018·2018-05-02

    Menarini Silicon Biosystems Recalls CellSearch Circulating Tumor Cell Kits

    Menarini Silicon Biosystems is recalling CellSearch Circulating Tumor Cell Kits because unusually high image counts may delay result reporting.

    Product
    CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1520-2018·2018-05-02

    Quidel MicroVue Intact PTH EIA Recalled for Potential Calibration Issues

    Diagnostic Hybrids, Inc. is recalling 26 units of the Quidel MicroVue Intact PTH EIA due to a potential loss of separation between calibrators that may impact assay calibration.

    Product
    Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1518-2018·2018-05-02

    CooperVision Clariti 1 Day Contact Lenses Recalled for Incorrect Expiration Date

    CooperVision is recalling specific lots of Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1479-2018·2018-05-02

    Medtronic DxTerity Diagnostic Catheter Recalled for Incorrect Box Labeling

    Medtronic is recalling 855 units of DxTerity Diagnostic Catheters because the outer box displays an incorrect 6 French size indicator, though the catheters inside are correct.

    Product
    Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1464-2018·2018-05-02

    Ace Surgical Supply Recalls Mispackaged Double Blade Shoe Unigraft Knives

    Ace Surgical Supply Co., Inc. is recalling six units of Double Blade Shoe F/Unigraft Knives because a single blade shoe was mistakenly packaged instead of the intended double blade.

    Product
    Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1517-2018·2018-05-02

    CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date

    CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1515-2018·2018-05-02

    CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date

    CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1516-2018·2018-05-02

    CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date

    CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1420-2018·2018-04-25

    Autochair Milford Smartbase Recalled Due to Leg Folding Hazard

    Autochair is recalling Milford Smartbase units because a weak spring and misaligned locking pin caused legs to fold, dropping a person.

    Product
    Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1409-2018·2018-04-25

    Philips Brilliance iCT SP CT Systems Recalled for Emergency Stop Defect

    Philips is recalling 19 Brilliance iCT SP CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.

    Product
    Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
    Category
    Medical Device
    Distribution
    Distributed nationwide