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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

21201–21225 of 27682

  • HighFDA (Devices)·Z-2572-2016·2016-08-24

    Medtronic Recalls Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling 1,440 Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP 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-2582-2016·2016-08-24

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

    Synthes (USA) Products LLC is voluntarily recalling 182 units of Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 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-2581-2016·2016-08-24

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

    Synthes (USA) Products LLC is voluntarily recalling 90 units of 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/20mm; Catalog ID 487.962 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-2552-2016·2016-08-24

    Reshape Medical Recalls ReShape Integrated Dual Balloon System Due to Assembly Error

    Reshape Medical Inc. is recalling 56 units of the ReShape Integrated Dual Balloon System because a manufacturing assembly error may cause saline leakage during inflation.

    Product
    ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2555-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling 19,200 Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 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-2546-2016·2016-08-24

    Medtronic EnVeo Delivery Catheter System Recalled for Vascular Trauma Risk

    Medtronic is recalling 7,319 EnVeo Delivery Catheter Systems worldwide due to a potential for vascular trauma during use.

    Product
    Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2423-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i is recalling 1,648,273 dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Argon Modified Flat l Electrodes due to a potential sterile barrier breach.

    Product
    Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 63,320 units distributed worldwide.

    Product
    Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2570-2016·2016-08-24

    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 lots 209358X through 60870083X distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP 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-2541-2016·2016-08-24

    TYRX Neuro Absorbable Antibacterial Envelope Recalled for Manufacturing Validation Issues

    TYRX Inc. is recalling 194 units of the TRYX Neuro Absorbable Antibacterial Envelope because manufacturing processes were not adequately validated.

    Product
    TRYX Neuro 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-2563-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrodes Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall affects 6,381 units distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 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-2565-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 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 single…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2551-2016·2016-08-24

    Merge Unity Z3D Software Recalled for Calcium Score Inaccuracy

    Merge Healthcare is recalling Merge Unity Z3D software because it cannot accurately determine calcium scores for scans with slice thicknesses other than 3 mm.

    Product
    Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2462-2016·2016-08-24

    Biomet 3i Recalls Drill Stop Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Drill Stop Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Drill Stop Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2016·2016-08-24

    Biomet 3i Recalls Twist Lock Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling Twist Lock Coping Dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    Certain Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2564-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 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-2529-2016·2016-08-24

    Ab Sciex QTRAP 4500MD Mass Spectrometer Software Recall for Incorrect Results

    Ab Sciex is recalling 28 QTRAP 4500MD mass spectrometers because MultiQuant MD software may display incorrect quantitative results when using the Sum Multiple Ions feature.

    Product
    AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2539-2016·2016-08-24

    TYRX Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes

    TYRX Inc. is recalling 3,460 units of TRYX Antibacterial Envelopes because manufacturing processes were not adequately validated.

    Product
    TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 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-2592-2016·2016-08-24

    Avid Medical Recalls Unlabeled Latex-Containing Telfa Dressing Kits

    Avid Medical is recalling 200 custom procedure trays that included latex-containing Telfa dressings without latex warnings. The products were distributed to Virginia and Massachusetts.

    Product
    MAMMOGRAPHY
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2584-2016·2016-08-24

    Synthes Titanium Single Vector Distractor Body Recalled for Fastener Separation

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

    Product
    TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 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