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

Category

Minimum severity

Clear filters

24026–24050 of 40299

  • ModerateFDA (Devices)·Z-1773-2018·2018-05-16

    Bard POWERPORT ClearVUE Slim Implantable Port Recalled for Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling 10 units of POWERPORT ClearVUE Slim Implantable Port kits because the included Patient ID Card contains incorrect port flushing instructions.

    Product
    POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1677-2018·2018-05-16

    Siemens IMMULITE Assay Recalled Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assays because biotin can interfere with results, potentially affecting patient care.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1680-2018·2018-05-16

    Siemens IMMULITE Gastrin Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1644-2018·2018-05-16

    Mako Surgical Recalls Mislabelled Restoris MCK Tibial Baseplates

    Mako Surgical Corporation is recalling 126 Restoris MCK Tibial Baseplates due to incorrect sizing labels. The devices were distributed to facilities in the US and several international countries.

    Product
    RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-1691-2018·2018-05-16

    Siemens IMMULITE 2000 BR-MA (CA15-3) Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 BR-MA (CA15-3) assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1630-2018·2018-05-16

    Integra Manuka Honey Wound Gel Recalled for Incorrect Manufacturing Record

    Integra LifeSciences Corp. is recalling Manuka Honey Wound Gel due to an incorrect part number listed in a master manufacturing record.

    Product
    Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1631-2018·2018-05-16

    Randox Lipase Assay Recalled for Potential Contamination on Rx Instruments

    Randox Laboratories is recalling Lipase Assay kits due to potential contamination risks on Rx instruments. The recall affects specific lots distributed in West Virginia and Puerto Rico.

    Product
    Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1692-2018·2018-05-16

    PerkinElmer Recalls NeoBase Succinylacetone Assay Solution Due to Leaking Vials

    PerkinElmer is recalling NeoBase Succinylacetone Assay Solution because leaking vials may cause minor allergic skin reactions if proper attire is not used.

    Product
    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923…
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1632-2018·2018-05-16

    Michigan Instruments Recalls Thumper Cardiopulmonary Resuscitator Due to Valve Defect

    Michigan Instruments is recalling 38 Thumper Cardiopulmonary Resuscitators because a valve defect may prevent the device from delivering chest compression depth.

    Product
    Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1760-2018·2018-05-16

    Bard POWERPORT ClearVUE Implantable Port Recalled for Incorrect Instructions

    Bard Peripheral Vascular Inc is recalling 359 units of POWERPORT ClearVUE implantable ports because the included patient ID card contains incorrect flushing instructions.

    Product
    POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1757-2018·2018-05-16

    Tornier Aequalis Humeral Nail Drill Bit Recall for Packaging Defect

    Tornier is recalling Aequalis Humeral Nail Drill Bits because the tips may puncture sterile packaging, potentially compromising sterility.

    Product
    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1744-2018·2018-05-16

    Hyphen BioMed Recalls ZYMUTEST HIA IgGAM Assay Kits Due to Incorrect Package Insert

    Hyphen BioMed is recalling 281 units of the ZYMUTEST HIA IgGAM assay because the package insert incorrectly states the kits can be used with serum and other fluids, when they should only be used with plasma.

    Product
    ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1656-2018·2018-05-16

    Siemens Dimension Vista ALTI Assay Recalled for Drug Interference

    Siemens is recalling Dimension Vista ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.

    Product
    Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1800-2018·2018-05-16

    Siemens Healthcare Recalls EMIT II Plus 6-Acetyl Morphine Reagents

    Siemens Healthcare Diagnostics is recalling EMIT II Plus 6-Acetyl Morphine reagents due to incorrect calibrator levels listed in the calibration steps.

    Product
    Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-1780-2018·2018-05-16

    MHC Medical Recalls EasyTouch Insulin Syringes Due to Labeling Error

    MHC Medical Products LLC is recalling 46,600 EasyTouch insulin syringes because retail shelf cartons may display an incorrect lot number.

    Product
    EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1799-2018·2018-05-16

    Siemens Syva EMIT II Plus 6-Acetylmorphine Recalled for Calibration Error

    Siemens Healthcare Diagnostics is recalling Syva EMIT II Plus 6-Acetylmorphine reagents because the calibrator level listed in the qualitative calibration steps is incorrect.

    Product
    Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1603-2018·2018-05-09

    Philips MultiDim Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 184 MultiDim Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1605-2018·2018-05-09

    Philips MultiDiagnost Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 37 MultiDiagnost Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1541-2018·2018-05-09

    PerkinElmer Specimen Gate Screening Center Software Recall for Data Errors

    PerkinElmer is recalling Specimen Gate Screening Center software due to potential errors in neonatal screening results, including false negatives and positives.

    Product
    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1607-2018·2018-05-09

    Philips MD-Eleva Medical Imaging System Recalled for Tilt Actuator Failure

    Philips is recalling 199 MD-Eleva imaging systems because a tilt actuator may break, causing the table to rotate uncontrollably at high speed.

    Product
    Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1606-2018·2018-05-09

    Philips MD-Eleva Imaging System Recalled for Uncontrolled Table Rotation

    Philips is recalling 206 MD-Eleva imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.

    Product
    Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1538-2018·2018-05-09

    Zimmer Biomet Recalls Modular Hip Head Components Due to Sizing Errors

    Zimmer Biomet is recalling 18 modular hip head components because two lots of different sizes were potentially commingled. This may lead to the use of an incorrect sized head.

    Product
    Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1609-2018·2018-05-09

    Philips MultiDiagnostic-Eleva Imaging System Recalled Due to Uncontrolled Table Rotation

    Philips is recalling the MultiDiagnostic-Eleva imaging system because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.

    Product
    MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1585-2018·2018-05-09

    Hitachi MHI-TM2000 Linear Accelerator Recalled for Software Anomaly

    Hitachi is recalling one MHI-TM2000 Linear Accelerator System in New York due to a software anomaly that may prevent patient positioning correction, potentially irradiating the wrong body part.

    Product
    MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1608-2018·2018-05-09

    Philips MultiDiagnostic-Eleva Recalled Due to Uncontrolled Table Rotation Hazard

    Philips Medical Systems is recalling 184 MultiDiagnostic-Eleva systems because a broken actuator fixation can cause the table to rotate uncontrollably at high speed.

    Product
    MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide