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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30301–30325 of 40449

  • ModerateFDA (Devices)·Z-1597-2016·2016-05-11

    Alcon Recalls INFINITI Ultrasound Packs Due to Tubing Leakage

    Alcon Research is recalling INFINITI Ultrasound Packs because the irrigation line tubing may leak near the white luer.

    Product
    INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1593-2016·2016-05-11

    Carestream Image Suite V3 Recalled for Incorrect Image Annotation

    Carestream Health is recalling Image Suite V3 units due to a software error that displays incorrect left/right image annotations.

    Product
    CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1594-2016·2016-05-11

    Carestream Image Suite V4 Recalled for Incorrect Image Annotation Display

    Carestream Health is recalling Image Suite V4 systems because a complaint reported that image annotations displayed 'L (Left)' instead of 'R (Right)'.

    Product
    CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1603-2016·2016-05-11

    Ferno-Washington Recalls Pediatric Traction Splint Straps Due to Labeling Error

    Ferno-Washington is recalling 153 pediatric traction splint strap kits because they were shipped in adult-labeled packaging. This labeling error could lead to the use of the wrong size equipment for patients.

    Product
    Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1605-2016·2016-05-11

    Medtronic CareLink Monitors Recalled for Firmware Dial-Up Configuration Error

    Medtronic is recalling CareLink and CareLink Express monitors because a firmware update contained incorrect dial-up configuration data, potentially preventing data transmission to the CareLink Network.

    Product
    Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1595-2016·2016-05-11

    Radiometer TCM CombiM Modules Recalled for Alarm Volume Error

    Radiometer America is recalling TCM CombiM Modules 903-111 because the alarm may sound louder than the pre-set maximum volume.

    Product
    TCM CombiM Modules 903-111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1607-2016·2016-05-11

    Toshiba Celesteion PET/CT Systems Recalled for Detector Performance Degradation

    Toshiba American Medical Systems is recalling three Celesteion PET/CT systems due to potential degradation of detector performance.

    Product
    Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1587-2016·2016-05-11

    Livongo Health Recalls In Touch Blood Glucose Monitoring System Inserts

    Livongo Health is recalling 63,000 units of the In Touch Blood Glucose Monitoring System because the instructional insert omitted specific sensor accuracy limitations.

    Product
    The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1592-2016·2016-05-11

    Siemens ACUSON SC2000 Ultrasound System Recalled for Trackball Control Failure

    Siemens is recalling 87 ACUSON SC2000 ultrasound systems because the trackball may fail to control specific imaging parameters during transesophageal procedures.

    Product
    ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1604-2016·2016-05-11

    Ferno-Washington Recalls Traction Splint Straps Due to Incorrect Packaging Labels

    Ferno-Washington Inc. is recalling 270 traction splint strap kits because the outside packaging labels for adult and pediatric sizes were swapped.

    Product
    Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1602-2016·2016-05-11

    Medtronic Midas Rex Dissecting Tools Recalled for Labeling Errors

    Medtronic is recalling 81 Midas Rex Dissecting Tools due to incorrect color coding and attachment references on the labeling.

    Product
    Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1591-2016·2016-05-11

    Biosense Webster Recalls Pentaray Catheters for Labeling Clarification

    Biosense Webster is recalling Pentaray Catheters to clarify contraindication language regarding patients with prosthetic valves in the product labeling.

    Product
    Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1580-2016·2016-05-04

    Hologic InPlex CF Molecular Test Recalled for False Positives and Leaking

    Hologic is recalling InPlex CF Molecular Tests due to false positive results and leaking cards, which could lead to unnecessary invasive testing during pregnancy.

    Product
    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1583-2016·2016-05-04

    Mako Surgical Recalls RESTORIS PST RIO Offset Shell Impactor

    Mako Surgical Corporation is recalling 96 units of the RESTORIS PST RIO Offset Shell Impactor due to a potential disassociation of the orientation pin.

    Product
    RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2016·2016-05-04

    Research Instruments Recalls Integra 3 Micromanipulators Due to Faulty Power Cable

    Research Instruments Ltd is recalling 380 Integra 3 micromanipulators because they were fitted with a potentially faulty power supply cable.

    Product
    Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1554-2016·2016-05-04

    Horiba Recalls ABX Pentra 400 and C400 Clinical Chemistry Analyzers

    Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers due to malfunctions triggered by specific system alarms.

    Product
    Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2016·2016-05-04

    GE Healthcare Aisys Anesthesia Machines Recalled for Suction Tubing Defect

    GE Medical Systems is recalling Aisys and Aisys CS2 anesthesia machines because kinked vacuum suction tubing may cause inadequate airway clearance and ventilation.

    Product
    GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1559-2016·2016-05-04

    Becton Dickinson Recalls Listeria-Contaminated Trypticase Soy Agar Plates

    Becton Dickinson is recalling Trypticase Soy Agar and MacConkey II Agar plates contaminated with Listeria monocytogenes. The non-sterile media are used for growing and detecting bacteria.

    Product
    Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2016·2016-05-04

    Horiba Recalls ABX Pentra 400 Analyzers Due to Malfunctions

    Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers because they malfunction when specific alarms appear on the system.

    Product
    ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1561-2016·2016-05-04

    Elekta Radionuclide Radiation Therapy System Recalled for Frame Adapter Latch Defect

    Elekta is recalling 217 Radionuclide Radiation Therapy Systems because frame adapter latches can lock without proper pin insertion, potentially compromising treatment accuracy.

    Product
    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1563-2016·2016-05-04

    3M Steri-Vac Gas Sterilizer Valves Recalled for Labeling Error

    3M is recalling 74 Steri-Vac Gas Sterilizer valves due to a labeling error that could cause incorrect installation and potential valve failure.

    Product
    3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1558-2016·2016-05-04

    Siemens SOMATOM Force CT Systems Recalled for Image Artifacts

    Siemens is recalling 37 SOMATOM Force CT systems because a software error in the Neonate Head protocol may cause image artifacts, potentially leading to misdiagnosis.

    Product
    SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2016·2016-05-04

    Hologic Recalls CF InPlex ASR Cards Due to False Positive Results

    Hologic is recalling CF InPlex ASR Cards because they may produce false positive results or leak, potentially leading to unnecessary invasive testing during pregnancy.

    Product
    CF InPlex ASR Card; Catalog Number: 95-0501.
    Category
    Medical Device
    Distribution
    30 states