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

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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

39751–39775 of 40480

  • ModerateFDA (Devices)·Z-0043-2013·2012-10-17

    IDS-iSYS N-Mid Osteocalcin Control Set Recalled for Labeling Errors

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin Control Sets because they were labeled as IVDs instead of Research Use Only.

    Product
    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2013·2012-10-17

    Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays because they may show higher imprecision when used on Beckman Coulter AU Systems.

    Product
    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0029-2013·2012-10-17

    Alere Recalls Triage TOX Drug Screen Kits Due to Mislabeled Boxes

    Alere San Diego, Inc. is recalling Triage TOX Drug Screen kits because the boxes containing the test devices were mislabeled.

    Product
    Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2013·2012-10-17

    Immunodiagnostics Systems Recalls IDS-iSYS Ostase BAP Assay Due to Labeling Error

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP assays because they were labeled for in vitro diagnostic use despite not being registered for that purpose in the US.

    Product
    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2013·2012-10-17

    IDS-iSYS Intact PINP Assay Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Intact PINP assays because they were labeled for In Vitro Diagnostic use but are not registered for that purpose in the US.

    Product
    IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0055-2013·2012-10-17

    ICU Medical Recalls 3 Port Off Manifold Due to Component Commingling

    ICU Medical is recalling 60 units of a 3 Port Off Manifold waste system because a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

    Product
    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0033-2013·2012-10-17

    Beckman Coulter Recalls CYTO-STAT Reagents Due to Labeling Updates

    Beckman Coulter is recalling CYTO-STAT tetraCHROME reagents because stability claims in the product labeling need to be updated to align with current standards.

    Product
    CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2013·2012-10-17

    IDS-iSYS Osteocalcin Assay Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin assays because they were labeled as In Vitro Diagnostics (IVD) despite not being registered for that use in the US.

    Product
    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2478-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because complaints report sub-optimal fit with mating components, leading to intraoperative dislodging.

    Product
    12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2474-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2484-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling provisional femoral heads used in hip surgery due to reports of sub-optimal fit with mating components.

    Product
    00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2473-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2482-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling provisional femoral heads used in hip surgery due to reports of sub-optimal fit with mating components.

    Product
    00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2477-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2493-2012·2012-10-10

    Zimmer Recalls Cemented Tibial Drills Due to Bone Perforation Reports

    Zimmer, Inc. is recalling 60 Cemented Tibial Drills for the Persona Personalized Knee System after three reports of tibial cortex perforation during use.

    Product
    Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2475-2012·2012-10-10

    Zimmer VerSys Provisional Femoral Heads Recalled for Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can cause intraoperative dislodging.

    Product
    00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2480-2012·2012-10-10

    Zimmer Recalls MIS Slotted Femoral Head Provisional Medical Devices

    Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.

    Product
    00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2476-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0011-2013·2012-10-10

    Philips HeartStart XL Defibrillators Recalled for Battery Failure Risk

    Philips is recalling HeartStart XL Defibrillators used with specific M3516A batteries that may fail without warning, potentially causing the device to shut down unexpectedly during use.

    Product
    Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2481-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling MIS and VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.

    Product
    00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2483-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices because they may fit too loosely or too tightly with mating components.

    Product
    00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2479-2012·2012-10-10

    Zimmer Recalls Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling specific provisional femoral heads used in hip surgery due to reports of improper fit with mating components.

    Product
    00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2012·2012-10-10

    Philips Digital Diagnost Patient Carriage Footplate Recall

    Philips is recalling Digital Diagnost patient carriages because the footplate hook may fail, causing the footplate to fall on patients or operators.

    Product
    Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0009-2013·2012-10-10

    Accuro Wound Pro Apex Negative Pressure Wound Therapy Pump Recall

    Accuro Medical Products is recalling 919 Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pumps because they may fail to operate or malfunction without notifying the user.

    Product
    Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2012·2012-10-10

    Biomet Recalls OptiLock T15 AO Drivers Due to Fit Issues

    Biomet, Inc. is recalling 363 units of OptiLock T15 AO Drivers because they may not properly lock into specified screw heads.

    Product
    Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in…
    Category
    Medical Device
    Distribution
    Distributed nationwide