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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35776–35800 of 40449

  • ModerateFDA (Devices)·Z-1689-2014·2014-06-11

    Bard Ventralight ST Mesh Recall for Potential Sterile Pouch Seal Issues

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile inflation assembly pouch may be open or have a weak seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1693-2014·2014-06-11

    Bard Ventralight ST Mesh Recall for Potential Sterility Compromise

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1691-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Defects

    Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS 6" Circle due to potential defects in the sterile inflation assembly pouch seal.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1680-2014·2014-06-11

    Bacterin Elutia Wound Drains Recalled for Missing Dose Audits

    Bacterin International is recalling Elutia Hubless Coated Silicone Surgical Wound Drains because quarterly dose audits were omitted. The products were appropriately sterilized.

    Product
    Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1674-2014·2014-06-11

    CryoLife Recalls BioGlue Surgical Adhesive Due to Albumin Component Failure

    CryoLife, Inc. is recalling 6,190 units of BioGlue Surgical Adhesive because the serum albumin component failed to meet internal shelf-life specifications.

    Product
    BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1677-2014·2014-06-11

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System due to a software anomaly that may delay patient test results.

    Product
    enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1710-2014·2014-06-11

    Leica CD15 Antibody Recalled for Reduced Function Before Expiration

    Leica Microsystems is recalling 145 units of CD15 antibody that may not function as intended before the expiration date due to age-related staining issues.

    Product
    Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1684-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects

    Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1692-2014·2014-06-11

    Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Issues

    Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile pouch holding the inflation assembly may have a weak seal or be open.

    Product
    Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1683-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects

    Davol, Inc. is recalling Composix LP with Echo PS hernia mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2014·2014-06-11

    Integra Licox Test Kit Recall for Erroneous Calibration Messages

    Integra LifeSciences is recalling Licox Test Kits that may display false calibration failure messages or out-of-range results when used with specific PtO2 monitors.

    Product
    Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1682-2014·2014-06-11

    Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Issues

    Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, potentially compromising sterility.

    Product
    Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1698-2014·2014-06-11

    Leica Monoclonal Antibody Recalled for Reduced Functionality

    Leica Microsystems is recalling Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi because it does not function as intended up to the expiry date.

    Product
    Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1685-2014·2014-06-11

    Bard Composix LIP Mesh Recall Due to Potential Packaging Seal Defects

    Davol, Inc. is recalling specific lots of Bard Composix LIP Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.

    Product
    Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1697-2014·2014-06-11

    Integra Newdeal SURFIX Screws Recalled for Packaging Labeling Error

    Integra LifeSciences is recalling specific lots of SURFIX locking screws because some 22mm units were mislabeled as 30mm units.

    Product
    Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1705-2014·2014-06-11

    Spacelabs Ultraview SL Command Module Recalled for Software Anomaly

    Spacelabs Healthcare is recalling 64 Ultraview SL Command Modules because a software anomaly causes false positive temperature alarms.

    Product
    Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1660-2014·2014-06-04

    Physio-Control Recalls LIFEPAK 1000 Defibrillators Due to Unexpected Shutdowns

    Physio-Control is recalling 96,611 LIFEPAK 1000 defibrillators because a software malfunction can cause the device to shut down unexpectedly, potentially failing to deliver a life-saving shock.

    Product
    LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1661-2014·2014-06-04

    Medtronic Temporary Pacemaker Recalled for Pacing Rate Defect

    Medtronic is recalling 16,337 temporary pacemakers worldwide because oxidation on internal contacts can cause the pacing rate to increase unexpectedly to 180 pulses per minute.

    Product
    Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1672-2014·2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Controls Due to Performance Shift

    Abbott is recalling ARCHITECT Intact PTH Controls because a performance shift may cause falsely elevated results on patient samples.

    Product
    ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2014·2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Performance Shift

    Abbott Laboratories is recalling 7,780 kits of ARCHITECT Intact PTH Calibrators because a performance shift may cause falsely elevated patient results.

    Product
    ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1658-2014·2014-06-04

    Siemens ADVIA Centaur Vitamin D Test Recalled for Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling 40,266 ADVIA Centaur Systems VitD Total 100 test kits because samples containing fluorescein may interfere with the assay results.

    Product
    ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2014·2014-06-04

    Synthes ProDisc-C Milling Bits Recalled Due to Breakage Risk

    Synthes, Inc. is recalling specific lots of ProDisc-C 2.0mm Milling Bits because they have an increased potential to break during use.

    Product
    Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1664-2014·2014-06-04

    Beaver-Visitec Anterior Chamber Cannula Recalled for Sharp Tip Needle

    Beaver-Visitec International Inc. is recalling Visitec Anterior Chamber Cannulas because some units contain a sharp tip needle instead of a blunt tip cannula.

    Product
    Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2014·2014-06-04

    Siemens Linear Accelerator Recall for Unvalidated Stereotactic Accessories

    Siemens Medical Solutions is recalling nine Linear Accelerator units because they may be used with unvalidated stereotactic accessories.

    Product
    Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1654-2014·2014-06-04

    Siemens ADVIA Centaur TSH3 Ultra Reagent Recall Due to Interference

    Siemens is recalling ADVIA Centaur TSH3 Ultra reagent kits because samples containing fluorescein may interfere with test results.

    Product
    ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide