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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21226–21250 of 27682

  • HighFDA (Devices)·Z-2583-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Bodies Due to Fastener Separation Risk

    Synthes (USA) Products LLC is voluntarily recalling 413 Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2016·2016-08-24

    Ab Sciex Mass Spectrometer Software Recall for Incorrect Quantitative Results

    Ab Sciex is recalling MultiQuant MD software for Triple Quad 4500MD systems because it may display incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2571-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Wire J-Hook Electrode Due to Sterility Risk

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes due to a potential package compromise that could breach the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2016·2016-08-24

    Nidek Optical Biometer AL-Scan Recalled for Inaccurate Axial Length Measurements

    Nidek Inc. is recalling 17 Optical Biometer AL-Scan devices because they measured axial lengths as much shorter than actual values.

    Product
    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2556-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: E25306 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2578-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Cylindrical Tip Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.

    Product
    Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2016·2016-08-24

    Synthes Titanium Single Vector Distractor Recalled for Fastener Separation Risk

    Synthes is recalling Titanium Single Vector Distractor Proximal Foot/Left devices because a fastener may separate prematurely from the plate.

    Product
    TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2016·2016-08-24

    Toshiba Recalls Xario Ultrasound Systems Due to Overheating Software Error

    Toshiba American Medical Systems is recalling 93 Xario 100 and 200 Diagnostic Ultrasound Systems because a software error may cause the devices to become hot.

    Product
    Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2585-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Proximal Foot Plates

    Synthes is voluntarily recalling Titanium Single Vector Distractor Proximal Foot Plates because the fastener may separate prematurely from the plate.

    Product
    TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2540-2016·2016-08-24

    TYRX Absorbable Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes

    TYRX Inc. is recalling 2,993 units of the TRYX Absorbable Antibacterial Envelope because key manufacturing processes were not adequately validated.

    Product
    TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2553-2016·2016-08-24

    Stanmore METS SMILES Total Knee Replacement Recall for Fit Issues

    Stanmore Implants Worldwide Ltd. is recalling 3 units of METS SMILES Total Knee Replacements because the femoral plateau plates may not fit the intended mating component.

    Product
    METS SMILES Total Knee Replacement
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2548-2016·2016-08-24

    Cepheid Recalls Xpert MRSA Diagnostic Kits Due to Performance Issues

    Cepheid is recalling specific lots of Xpert MRSA diagnostic kits because internal investigations found potential performance issues at lower positive sample concentrations.

    Product
    Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal…
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-2526-2016·2016-08-24

    Ab Sciex API 3200MD Software Recall for Incorrect Quantitative Results

    Ab Sciex is recalling MultiQuant MD software for API 3200MD systems due to potential incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2016·2016-08-24

    Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece

    Straumann Manufacturing, Inc. is recalling 33 Bone Level Implants due to misalignment with the Loxim transfer piece markings, which may result in incorrect implant positioning.

    Product
    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2386-2016·2016-08-17

    Integra External Fixation System Wire Fixation Bolts Recalled for Breakage

    Integra LifeSciences Corp. is recalling Universal Wire Fixation Bolts because the Slotted Post broke during use at the surgical site.

    Product
    Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2402-2016·2016-08-17

    Invacare Bariatric Bed Junction Boxes Recalled for Fire Risk

    Invacare Corporation is recalling 1,011 Bariatric home care beds because the junction boxes may spark, posing a fire hazard in the presence of flammable materials.

    Product
    Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2342-2016·2016-08-17

    BioMerieux Recalls NucliSENS easyMAG Magnetic Silica Reagents

    BioMerieux is recalling NucliSENS easyMAG Magnetic Silica reagents due to customer complaints about amplification performance issues.

    Product
    NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2351-2016·2016-08-17

    Richard Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Contamination

    Richard-Allan Scientific Company is recalling 18 cases of 10% Neutral Buffered Formalin due to potential potassium hydroxide contamination that may affect immunohistochemistry test results.

    Product
    Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2401-2016·2016-08-17

    Invacare Bariatric Bed Foot Section Recalled for Fire Hazard

    Invacare Corporation is recalling 3,050 Bariatric Bed Foot Sections because a junction box defect may cause sparks and fire.

    Product
    Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2399-2016·2016-08-17

    Invacare Bariatric Bed Recalled for Junction Box Fire Risk

    Invacare is recalling 2,184 Bariatric Beds because a defect in the Junction Box may cause sparks, posing a fire hazard in the presence of flammable materials.

    Product
    Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2400-2016·2016-08-17

    Invacare Bariatric Bed Recalled for Potential Fire Hazard from Junction Box Sparks

    Invacare is recalling 2,702 Bariatric Beds because the junction box may spark, posing a fire risk in the presence of flammable materials.

    Product
    Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2387-2016·2016-08-17

    Integra External Fixation System Slotted Post Recall for Breakage During Use

    Integra LifeSciences is recalling 111 units of External Fixation System Slotted Posts because they broke during use at the surgical site.

    Product
    Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2388-2016·2016-08-17

    Edan Diagnostics Recalls EtCO2 Modules for Incorrect CO2 Readings

    Edan Diagnostics is recalling 521 EtCO2 modules used in patient monitors because they may provide incorrect CO2 readings.

    Product
    EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60…
    Category
    Medical Device
    Distribution
    Distributed nationwide