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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

39401–39425 of 40356

  • HighFDA (Devices)·Z-0258-2013·2012-11-14

    Kimberly-Clark Recalls MicroCool Sterile Surgical Gowns Due to Seal Defects

    Kimberly-Clark is recalling specific lots of MicroCool sterile surgical gowns because package seams may not be properly sealed, potentially compromising sterility.

    Product
    MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0204-2013·2012-11-14

    Surgical Specialties Recalls Sharpoint IQ Slit Knives Due to Bent Tips

    Surgical Specialties is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0196-2013·2012-11-14

    Spacelabs Healthcare Recalls Xprezzon Bedside Monitor Touchscreen Displays

    Spacelabs Healthcare is recalling 169 Xprezzon bedside monitor touchscreen displays because alarm lights may fail to illuminate upon installation.

    Product
    The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2013·2012-11-14

    Sunquest Phlebotomy Interface Software Recall for Inappropriate Order Combination

    Sunquest Information Systems is recalling 9 units of its Outbound Phlebotomy Point of Care Interface software due to confirmed reports of inappropriate patient order combination.

    Product
    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0267-2013·2012-11-14

    Medacta Recalls Quadra S Offset Broach Handle Due to Rivet Failure Risk

    Medacta USA Inc is recalling 12 units of the Quadra S Offset Broach Handle because a rivet may become loose during surgery, preventing the locking mechanism from functioning.

    Product
    Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0257-2013·2012-11-14

    Kimberly-Clark Recalls Sterile Surgical Gowns Due to Potential Seal Failure

    Kimberly-Clark is recalling sterile surgical gowns because package seams may not remain sealed, potentially compromising sterility.

    Product
    ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2013·2012-11-14

    FDA Recalls Sharpoint IQ Slit Knives Due to Potential Bent Tips

    Surgical Specialties Puerto Rico Inc. is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0208-2013·2012-11-14

    Sechrist Hyperbaric Chamber Software Bug Recall

    Sechrist Industries is recalling 73 monoplace hyperbaric chambers to fix a software bug that could affect performance.

    Product
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0259-2013·2012-11-14

    AMS AdVance Male Sling System Recalled for Suture Degradation

    American Medical Systems is voluntarily recalling the AdVance Male Sling System because the resorbable suture may degrade before the 15-month shelf life expires.

    Product
    AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0236-2013·2012-11-14

    Zimmer Recalls Dynesys Set Screws Due to Labeling Discrepancies

    Zimmer, Inc. is correcting patient labels for Dynesys Set Screws manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Dynesys¿ Set screw M6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0240-2013·2012-11-14

    Zimmer Recalls Dynesys HA Pedicle Screws Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Dynesys HA Pedicle screws manufactured before March 2010 due to reported discrepancies between product and patient labels.

    Product
    Dynesys¿ HA Pedicle + set screw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0249-2013·2012-11-14

    Zimmer MS-30 Sterile Shafts Recalled for Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for MS-30 Sterile Shafts due to discrepancies in reference and lot numbers.

    Product
    MS-30 Shaft, Sterile, Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0245-2013·2012-11-14

    Zimmer Recalls Tibial Plates Due to Patient Label Discrepancies

    Zimmer Inc. is correcting patient labels for NCB-PT tibial plates manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    NCB¿-PT lateral proximal 3 hole tibial plate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0269-2013·2012-11-14

    Alphatec Spine Recalls Polyaxial Screw Assemblies Due to Incorrect Length Marking

    Alphatec Spine is recalling 11 units of the TI Standard Polyaxial Screw Assembly because they were laser marked with the incorrect length of 45 MM.

    Product
    TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0254-2013·2012-11-14

    Sysmex XE-2100 Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 1,099 XE-2100 Automated Hematology Systems because reticulocyte counts may be 21% lower than expected due to a low bias.

    Product
    Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0237-2013·2012-11-14

    Zimmer Recalls Dynesys Universal Spacers Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Dynesys Universal Spacers manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Dynesys¿ Universal spacer 6-45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0263-2013·2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu Medical Systems is recalling 133 mobile X-ray systems because certain units may not meet federal beam quality standards.

    Product
    0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0202-2013·2012-11-14

    Surgical Specialties Recalls Sharpoint IQ Slit Knives Due to Bent Tips

    Surgical Specialties is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0265-2013·2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu Medical Systems is recalling 3 mobile X-ray systems because they may not meet federal beam quality standards.

    Product
    0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0252-2013·2012-11-14

    Diagnostica Stago STA Satellite Analyzer Recalled for Incorrect INR Printouts

    Diagnostica Stago is recalling 237 STA Satellite Automated Multi-Parameter Analyzers because they may print incorrect INR values when using an external printer.

    Product
    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0238-2013·2012-11-14

    Zimmer Recalls Dynesys Stabilizing Cords Due to Labeling Discrepancies

    Zimmer, Inc. is correcting patient labels for Dynesys L.I.S. Stabilizing Cords manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Dynesys¿ L.I.S. Stabilizing cord Rx, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0227-2013·2012-11-14

    Zimmer Inc. Recalls Anatomical Shoulder Humeral Stems Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Anatomical Shoulder Humeral stems manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2013·2012-11-14

    Zimmer Inverse/Reverse Screw System Label Correction

    Zimmer, Inc. is correcting patient labels for Inverse/Reverse Screw systems manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Zimmer Inverse/Reverse Screw system,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0231-2013·2012-11-14

    Zimmer Recalls Shoulder Humeral Inserts Due to Label Discrepancies

    Zimmer Inc. is correcting patient labels for 74 anatomical shoulder humeral inserts manufactured before March 2010 due to reported discrepancies in reference and lot numbers.

    Product
    Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide