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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31651–31675 of 40449

  • ModerateFDA (Devices)·Z-0265-2016·2015-11-18

    Siemens Modularis VarioStar Lithotripter Recalled for Display Freeze Issue

    Siemens Medical Solutions is recalling 15 Modularis VarioStar lithotripters because a display freeze prevents current treatment data from being shown to users.

    Product
    MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0267-2016·2015-11-18

    Biomet 3i Dental Driver Tip Recalled for Mislabeling

    Biomet 3i is recalling 103 Narrow Right Angle Square Driver Tips that were mislabeled as hexed tips, creating a risk of improper use during dental procedures.

    Product
    Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0268-2016·2015-11-18

    Medtronic Perfusion Tubing Packs Recalled for Potential Header Bag Seal Breach

    Medtronic is recalling 496 Perfusion Tubing Packs due to a potential breach in the header bag seal. The affected lots were distributed nationwide in the US.

    Product
    Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0239-2016·2015-11-18

    Beckman Coulter Recalls Access CEA Assay Reagent Packs for Filling Errors

    Beckman Coulter is recalling Access CEA Assay reagent packs because they were filled incorrectly. The recall covers 11,406 units distributed worldwide.

    Product
    Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0270-2016·2015-11-18

    Stryker Spine Recalls Radius Rod to Rod Connectors for Missing Clearance

    Stryker Spine is recalling 42 units of Radius Rod to Rod Connectors because the device lacks the required FDA 510(k) clearance.

    Product
    Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0129-2016·2015-11-18

    Villa Radiology Systems Recalls Owandy I-MAX Touch 3D X-ray Units

    Villa Radiology Systems LLC is recalling six Owandy Radiology I-MAX Touch 3D X-ray units because they lack required accompanying information documents.

    Product
    Owandy Radiology I -MAX Touch 3D X-ray
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0235-2016·2015-11-18

    Stryker Recalls Reprocessed Surgical Drill Bits Due to Packaging Seal Issues

    Stryker Sustainability Solutions is recalling 1,202 reprocessed surgical drill bits and blades because packaging was not properly sealed.

    Product
    SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0253-2016·2015-11-18

    CooperSurgical Recalls MILEX Pessary Kits Due to Incorrect Packaging Labels

    CooperSurgical is recalling 144 MILEX Pessary Kits because the outer packaging displays incorrect size prints, although the pessary pouch itself is correctly marked.

    Product
    MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07 Product Usage: The Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0151-2016·2015-11-11

    Hamilton Medical Recalls HAMILTON-G5 Ventilators Due to Alarm Suppression Defect

    Hamilton Medical is recalling 1,128 HAMILTON-G5 ventilators because suctioning maneuvers can unintentionally suppress ventilation and alarms.

    Product
    HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0223-2016·2015-11-11

    Bard Flair Endovascular Stent Graft Recalled for Deployment Failures

    Bard Peripheral Vascular is recalling 292 units of the FLAIR Endovascular Stent Graft due to potential deployment failures during use.

    Product
    FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0205-2016·2015-11-11

    ConMed Recalls Arthroscopic Energy 50 Probe Due to Programming Error

    ConMed is recalling 276 Arthroscopic Energy 50 Probes with Suction because a programming error may generate excess heat, increasing the risk of tissue damage during surgery.

    Product
    Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0200-2016·2015-11-11

    Medtronic Achieve Electrical Cables Recalled for Potential Sterility Breach

    Medtronic is recalling 64 units of Achieve Electrical Cables (Model 990066) due to a potential sterility breach. The sterile, single-use cables were distributed to facilities in 16 states and DC.

    Product
    Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and…
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0224-2016·2015-11-11

    Mako RIO Robotic System Components Recalled for Damaged Locking Pins

    Mako Surgical Corporation is recalling RIO system locking pins and connectors because the pins are damaged during assembly.

    Product
    Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2016·2015-11-11

    Siemens e.cam Gamma Camera Recall for Radial Brake Failure

    Siemens Medical Solutions is recalling e.cam Gamma Camera systems due to a potential radial brake failure that could allow the detector to drift.

    Product
    e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2016·2015-11-11

    Brainlab Patient Data Manager Software Recalled for Image Display Errors

    Brainlab AG is recalling Patient Data Manager software versions 2.0.0 through 2.1.0 because objects may display incorrectly when users deselect fused reference datasets.

    Product
    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2016·2015-11-11

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Reboot Issues

    Philips is recalling HeartStart MRx monitor/defibrillators because they may reboot unexpectedly, interrupting or delaying therapy.

    Product
    HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2016·2015-11-11

    Alcon Custom Pak 9319-27 Recalled for Latex Glove Mislabeling

    Alcon Research, Ltd. is recalling five units of Custom Pak 9319-27 ophthalmic surgical devices because they contain latex gloves despite being labeled as latex-free.

    Product
    Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0196-2016·2015-11-11

    GE Recalls MR Surgical Suite II Tables Due to Transfer Mechanism Issue

    GE Medical Systems is recalling MR Surgical Suite II Tables because a defect in the transfer release mechanism may prevent patient transfer between the MR and surgical tables.

    Product
    MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0209-2016·2015-11-11

    Otto Bock Triton Smart Ankle Recalled Due to Software Issue

    Otto Bock is recalling the Triton Smart Ankle and iOS Galileo app due to a software issue that can cause unexpected foot movement, posing a fall risk.

    Product
    iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2016·2015-11-11

    FDA Recalls Robotic Hand Accessories Due to Pinch Hazard

    Interactive Motion Technologies is recalling eight robotic hand accessories for the InMotion Arm rehabilitation robot due to a potential pinch hazard if protective covers are removed.

    Product
    Robotic hand accessory to InMotion Arm, rehabilitation robot.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0194-2016·2015-11-11

    Baxter 15L Cycler Drainage Bags Recalled for Inlet Port Leakage

    Baxter Healthcare Corp. is recalling 19,440 units of 15L Cycler Drainage Bags due to leakage from the inlet port. The products were distributed in the US and Canada.

    Product
    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0221-2016·2015-11-11

    CareFusion Recalls SmartSite Extension Sets Due to Disconnection and Leakage

    CareFusion is recalling SmartSite Extension Sets because they may disconnect or leak. The recall affects 21,000 units distributed in the US and Canada.

    Product
    SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2016·2015-11-11

    GE Healthcare Recalls Centricity Universal Viewer Due to Inaccurate X-ray Measurements

    GE Healthcare is recalling Centricity Universal Viewer versions 6.0 and higher because magnified projection X-ray images may display inaccurate distance measurements.

    Product
    The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0225-2016·2015-11-11

    GE Healthcare Recalls Centricity PACS-IW Due to Inaccurate X-Ray Measurements

    GE Healthcare is recalling Centricity PACS-IW software because it may display inaccurate distance measurements for magnified projection X-ray images.

    Product
    The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed…
    Category
    Medical Device
    Distribution
    Distributed nationwide