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

Clear filters

31551–31575 of 40325

  • HighFDA (Devices)·Z-0249-2016·2015-11-18

    Stryker Recalls Triathlon MIS Modular Distal Capture Instruments

    Stryker is recalling specific lots of Triathlon MIS Modular Distal Capture instruments because they may disassociate during use.

    Product
    Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2016·2015-11-18

    Teleflex Medical Recalls Roesch Flexi-Slip Endotracheal Tube Stylets

    Teleflex Medical is recalling Roesch Flexi-Slip Endotracheal Tube Stylets because the plastic coating may split or break off.

    Product
    R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0260-2016·2015-11-18

    GE Healthcare Recalls SIGNA PET/MR 3.0T Scanners for SAR Display Error

    GE Healthcare is recalling 17 SIGNA PET/MR 3.0T scanners because displayed SAR values may be lower than actual levels, potentially exceeding safety limits during head or neck scans.

    Product
    GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high-resolution physiologic and anatomic information…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0258-2016·2015-11-18

    GE Healthcare Recalls Signa HDx 3.0T MRI Scanners for SAR Display Error

    GE Healthcare is recalling 350 Signa HDx 3.0T MRI scanners because displayed SAR values may be lower than actual head SAR levels, potentially exceeding safety limits.

    Product
    GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0266-2016·2015-11-18

    Biomet 3i Dental Driver Tips Recalled for Mislabeling

    Biomet 3i is recalling 96 dental driver tips because hexed tips were labeled as square tips, and square tips were marked with hexed identifiers.

    Product
    Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). 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-0252-2016·2015-11-18

    Biocare Medical Recalls Smooth Muscle Actin Immunohistochemistry Reagents

    Biocare Medical is recalling certain lots of Smooth Muscle Actin reagents because they may stain cell types that should be negative.

    Product
    Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the…
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0238-2016·2015-11-18

    Focus Diagnostics Recalls Anaplasma Phagocytophilum IFA IgM Test Kits

    Focus Diagnostics is recalling 38 Anaplasma phagocytophilum IFA IgM Test Kits due to a potential increase in invalid results.

    Product
    Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0233-2016·2015-11-18

    Utah Medical Recalls Myelo-Nate CSF Sampling Kits Due to Seal Compromise

    Utah Medical Products is recalling 21,403 Myelo-Nate CSF Sampling Kits because an internal inspection found a compromised sterile seal on one side of the tray.

    Product
    Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0244-2016·2015-11-18

    Cook Medical CXI Support Catheters Recalled Due to Product Mixing

    Cook Inc. is recalling specific lots of CXI Support Catheters because the 2.6FR curved and 4.0FR straight catheters were mixed during processing.

    Product
    Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0232-2016·2015-11-18

    Boston Scientific SQ-RX Subcutaneous Pulse Generator Recall for Telemetry Issues

    Boston Scientific is recalling three SQ-RX Model 1010 subcutaneous pulse generators shipped in dual-channel mode. This configuration may delay initial telemetry scans but does not affect therapy delivery.

    Product
    Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
    Category
    Medical Device
    Distribution
    2 states
  • 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