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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Minimum severity

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

Clear filters

22551–22575 of 27699

  • HighFDA (Devices)·Z-0292-2016·2015-11-25

    Leonhard Lang Recalls ECG Electrodes Due to Signal Transmission Failure

    Leonhard Lang Medizintechnik GmbH is recalling specific lots of ECG electrodes because they may fail to transmit signals or transmit poor signals before expiration.

    Product
    ECG Electrodes: 50007  Stablebase SBW55 50675  Stablebase SBW55-15 58051  Skintact W-60 50547  Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen 1900000440 59629 Cardionetics CN-15-W60 58789 Lessa 99.832.02…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0290-2016·2015-11-25

    Civco Medical Instruments Recalls Large Gauge Infiniti Plus Needle Guides

    Civco Medical Instruments is recalling 54 boxes of Large Gauge Infiniti Plus Needle Guides because the sterility of the product cannot be assured.

    Product
    CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2016·2015-11-25

    Civco Infiniti Plus Needle Guide Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 717 boxes of Infiniti Plus Needle Guides because the sterility of the product cannot be assured.

    Product
    CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2016·2015-11-25

    Civco Biopsy Starter Kit Recalled Due to Sterility Concerns

    Civco Medical Instruments is recalling 1,139 boxes of Biopsy Starter Kits because the sterility of the product cannot be assured.

    Product
    CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0297-2016·2015-11-25

    Roche Bulk Loader Module Recalled for Sample Contamination Risk

    Roche Diagnostics is recalling Bulk Loader Modules for cobas p 512/612 instruments because sample tubes may open during transport, causing system and sample contamination.

    Product
    Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0212-2016·2015-11-18

    Boston Scientific Recalls RotaWire Elite Guidewires Due to Fracture Complaints

    Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices due to complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.

    Product
    RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed…
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0248-2016·2015-11-18

    Maquet Universal Frame Recalled Due to Thromboembolic Event Reports

    Maquet is recalling Universal Frames and Adjustable Positioning Elements after two serious thromboembolic events were reported during lumbar spine surgery.

    Product
    Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0211-2016·2015-11-18

    Boston Scientific Recalls RotaWire Elite Guidewires Due to Wire Fracture Complaints

    Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices because of complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.

    Product
    RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation…
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0247-2016·2015-11-18

    Maquet Adjustable Positioning Elements Recalled Due to Thromboembolic Events

    Maquet is recalling Adjustable Positioning Elements used in spine surgery after two serious thromboembolic events were reported.

    Product
    Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0251-2016·2015-11-18

    Shimadzu C-arm Table Recall Due to Interference Risk

    Shimadzu Medical Systems is recalling 26 C-arm Tables because the C-arm may interfere with the table top under certain circumstances.

    Product
    Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0254-2016·2015-11-18

    GE Healthcare Recalls MRI Scanners Due to Potential SAR Limit Exceedance

    GE Healthcare is recalling 756 MRI scanners because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits during head or neck scans.

    Product
    GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0255-2016·2015-11-18

    GE Healthcare Recalls Signa 3.0T MRI Systems Due to SAR Display Error

    GE Healthcare is recalling 19 Signa 3.0T MRI systems because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa VH/i MR Imaging System. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2016·2015-11-18

    Teleflex Medical Recalls Rusch Flexi-slip Tracheal Tube Stylets

    Teleflex Medical is recalling Rusch Flexi-slip tracheal tube stylets because the plastic coating may split or break off.

    Product
    Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0261-2016·2015-11-18

    Stryker Vitallium Femoral Heads Recalled Due to Assembly Failure

    Stryker Howmedica Osteonics Corp. is recalling 201 Vitallium femoral heads because they could not be assembled with their corresponding stems during surgery.

    Product
    Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2016·2015-11-18

    Miramar Labs Recalls miraDry System for Labeling Update on Lubricant Use

    Miramar Labs is recalling 277 miraDry Systems to update labeling that reminds users to use only approved lubricants in a thin layer to prevent burns and blisters.

    Product
    miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0263-2016·2015-11-18

    Samsung GM60A-40S Radiographic System Recalled for Drive Control Defect

    NeuroLogica Corporation is recalling seven Samsung GM60A-40S radiographic systems because drive behavior may not be properly controlled when moving over conductive floors.

    Product
    Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0259-2016·2015-11-18

    GE Healthcare Recalls Signa HDxt 3.0T MRI Scanners for SAR Limit Concerns

    GE Healthcare is recalling 215 Signa HDxt 3.0T MRI scanners because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2016·2015-11-18

    Medtronic Recalls Amphirion Deep PTA Balloon Catheters Due to Seal Breach

    Medtronic is recalling Amphirion Deep PTA Balloon Catheters because a potential breach in the pouch seal may compromise the sterilized product.

    Product
    Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080152 AMP253210152 AMP020080152 AMP025080002 AMP030040002 AMP030150152…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2016·2015-11-18

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Hardware Defects

    Philips is recalling HeartStart MRx Monitor/Defibrillators because the CO2 inlet port can become inaccessible or the handle can separate from the housing.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0237-2016·2015-11-18

    Tekia Recalls Intraocular Lenses Due to Incorrect Diopter Power Labeling

    Tekia is recalling 50 units of Single Piece Hydrophilic Acrylic Intraocular Lenses because they may be labeled with the incorrect diopter power.

    Product
    TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0242-2016·2015-11-18

    WalkMed Infusion Pumps Recalled for Air Detection Failure

    WalkMed Infusion is recalling Triton Infusion Pumps because they may fail to detect air in the line when infusing Venofer.

    Product
    Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump). Used to pump fluids into a patient in a controlled manner.
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-0241-2016·2015-11-18

    DeRoyal Surgical Kits Recalled Due to Sterilant Exposure

    DeRoyal Industries is recalling specific lots of sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during the sterilization process.

    Product
    DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: TOTAL JOINT PACK A&B, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0250-2016·2015-11-18

    Ceterix NovoCut Suture Manager Recalled for Suture Cutting Risk

    Ceterix Orthopedics is recalling 1,364 NovoCut Suture Manager devices because they may cut sutures during knot tensioning, causing knots to unravel.

    Product
    NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide