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)

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31801–31825 of 40325

  • HighFDA (Devices)·Z-2813-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling RAPIDPoint 500 Lactate Cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2798-2015·2015-09-30

    Regard Custom Surgical Pack Recalled Due to Chemical Contamination and Sterility Concerns

    Resource Optimization & Innovation Llc is recalling 24 Regard Custom Surgical Packs because they may contain chemically contaminated scrub products and lack sterility assurance.

    Product
    Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2790-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrator Component

    Terumo is recalling 15 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 High Performance Hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2794-2015·2015-09-30

    Synthes Dynamic Locking Screw System Recalled for Pin Breakage

    Synthes (USA) Products LLC is recalling Dynamic Locking Screw Systems due to pin breakage during implant removal. This notice extends to additional consignees identified after a previous recall.

    Product
    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2814-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 1,213 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2791-2015·2015-09-30

    Terumo Cardiovascular Procedure Kits Recalled Due to Defective Hemoconcentrators

    Terumo is recalling 19 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2809-2015·2015-09-30

    Beckman Coulter MicroScan LabPro Software Recall for Manual Editing Error

    Beckman Coulter is recalling MicroScan LabPro software versions 1.0 to 4.11 because it incorrectly allows manual editing of carbohydrate substrates during specific manual readings.

    Product
    MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2812-2015·2015-09-30

    Siemens Medical Solutions Recalls Linear Accelerator Systems Due to Collision Risk

    Siemens Medical Solutions is recalling 26 linear accelerator systems and associated software because a defect could cause automatic movement, posing a collision risk to patients.

    Product
    ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2795-2015·2015-09-30

    Brainlab Disposable Reflective Marker Spheres Recalled for Separation Risk

    Brainlab AG is recalling Disposable Reflective Marker Spheres because they may separate at the mid-point seal, posing a risk to patients during image-guided surgery.

    Product
    Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2816-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 49 RAPIDPoint 500 Lactate Cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2787-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect

    Terumo is recalling 32 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2797-2015·2015-09-30

    Bien Air Dental Contra-Angles Recalled for Potential Tool Loosening

    Bien Air Dental SA is recalling specific EVO 15 contra-angles because the dental tool may loosen and be swallowed.

    Product
    Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2789-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators

    Terumo is recalling six custom cardiovascular procedure kits nationwide because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2786-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled for Defective Hemoconcentrators

    Terumo is recalling 5 Custom Cardiovascular Procedure Kits because they contain recalled Medivators HPH700 Hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2792-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect

    Terumo is recalling 17 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2780-2015·2015-09-30

    Edwards Lifesciences Recalls ThruPort Knot Pusher Due to Suture Fraying Risk

    Edwards Lifesciences is recalling 759 ThruPort Knot Pusher units because the device's tip design may cause suture fraying or splitting, potentially compromising suture knot integrity during cardiac surgery.

    Product
    ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2793-2015·2015-09-30

    Ecolab Recalls Microtek ORS Fluid Warming and Slush Drapes Due to Seal Defects

    Ecolab is recalling Microtek ORS Fluid Warming and Slush Drapes because sterile packaging seals may contain small channels, potentially compromising package integrity and sterility.

    Product
    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2811-2015·2015-09-30

    Synthes Cranial Flap Tube Clamp Recalled for Incorrect MR Safe Labeling

    Synthes (USA) Products LLC is recalling Cranial Flap Tube Clamps and Crimping Devices because they were labeled MR Safe without required testing protocols.

    Product
    Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2807-2015·2015-09-30

    Olympus TJF-Q180V Duodenoscope Recall Issued for Revised Reprocessing Procedures

    Olympus America Inc. is recalling 6,109 TJF-Q180V duodenoscopes to implement new cleaning and disinfection procedures.

    Product
    EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2796-2015·2015-09-30

    OrthoPediatrics Recalls 3.5mm Non Locking Cortical Screws Due to Packaging Error

    OrthoPediatrics Corp is recalling 3.5mm Non Locking Cortical Screws because the packaging may contain a different screw size than labeled.

    Product
    3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2805-2015·2015-09-30

    Fujifilm EPX 2500 Operation Manual Recalled for Incorrect Endoscope Specifications

    Fujifilm is recalling 60 EPX 2500 Operation Manuals and sales brochures that incorrectly identify the ED-530XT endoscope's image capabilities.

    Product
    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2804-2015·2015-09-30

    Leica ASP6025 Tissue Processor Recalled for Incomplete Bottle Filling

    Leica Microsystems is recalling ASP6025 Tissue Processors because they may incorrectly detect empty bottles during filling, preventing the completion of a 5-liter fill.

    Product
    The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
    Category
    Medical Device
    Distribution
    34 states