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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37651–37675 of 40325

  • HighFDA (Devices)·Z-1992-2013·2013-08-28

    Stryker Visum 300 Ceiling-mounted Exam Light Recalled for Weld Defect

    Stryker Communications is recalling 1,375 Visum 300 Ceiling-mounted Exam Lights due to a potential incomplete final weld on the drop tube flange.

    Product
    Stryker Visum 300 Ceiling-mounted Exam Light.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2012-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2013·2013-08-28

    Zimmer NexGen Knee System Recall Due to Unapproved Component Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved micro and standard combinations.

    Product
    65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1998-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2009-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Femur CR PRC FEM COMP SIZE DML Rx, Sterile; 00597001404 Femur CR PRC FEM COMP SIZE DMR Rx, Sterile; 00597001503 Femur CR PRC FEM COMP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX POR HATCP FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2013·2013-08-28

    Medtronic MiniMed Paradigm Reservoirs Recalled for Potential Leaking Risk

    Medtronic is recalling specific lots of Paradigm insulin reservoirs because they may leak, potentially delivering less insulin than intended.

    Product
    Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1981-2013·2013-08-28

    Zimmer Recalls Moore Hip Prosthesis Stems for Sterile Barrier Testing

    Zimmer is recalling 1,710 Moore Hip Prosthesis Long Fenestrated Stems to test sterile barrier integrity after a review of historic packaging validations.

    Product
    Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1985-2013·2013-08-28

    Sorin Group Recalls Edwards Lifesciences Suction Wands Due to Plastic Particles

    Sorin Group is recalling Edwards Lifesciences Suction Wand Model S099B because plastic particles were found inside the packaging pouch.

    Product
    Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1997-2013·2013-08-28

    Beckman Coulter Recalls Hemoccult ICT Fecal Occult Blood Test Kits

    Beckman Coulter is recalling 68,116 Hemoccult ICT units due to increased sensitivity at borderline positive levels, which may cause false positives.

    Product
    Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1983-2013·2013-08-28

    Gyrus Medical Recalls Sterile Bipolar Dissecting Forceps Due to Seal Failure

    Gyrus Medical is recalling 1,140 sterile bipolar dissecting forceps units because accelerated aging tests showed a compromised sterile packaging seal.

    Product
    GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2013·2013-08-28

    Atrium Medical Recalls PleuraGuide Chest Tube Kits Due to Missing Instructions

    Atrium Medical Corporation is recalling 6,516 PleuraGuide Disposable Chest Tube Kits because individual component instructions for use are missing.

    Product
    PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1996-2013·2013-08-28

    Smith & Nephew Recalls Genesis II Knee Trial Inserts Due to Color Error

    Smith & Nephew is recalling nine Genesis II Cruciate Retaining Articular Insert trial units because they were produced with the wrong color material.

    Product
    GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1991-2013·2013-08-28

    ConvaTec Flexi-Seal Signal Plus Recalled for Packaging Labeling Error

    Convatec Inc. is recalling 22,896 units of Flexi-Seal Signal Plus due to a manufacturing irregularity where lot numbers were duplicated on the packaging.

    Product
    ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1964-2013·2013-08-28

    Philips MobileDiagnost wDR Recalled for Non-Compliant Instructions for Use

    Philips Healthcare is recalling MobileDiagnost wDR systems because the Instructions for Use fail to comply with a Federal standard regarding generator value tolerance levels.

    Product
    Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1990-2013·2013-08-28

    ConvaTec Flexi-Seal Fecal Management System Recalled for Packaging Error

    Convatec is recalling Flexi-Seal Signal Fecal Management Systems because the lot number convention was duplicated on the packaging for certain lots.

    Product
    ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1897-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical Corporation is recalling Nova Max Glucose Test Strips due to reports of false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1899-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling 721,810 Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1900-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings, potentially affecting diabetes management.

    Product
    Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1966-2013·2013-08-21

    Medtronic Recalls Pediatric Arterial Filters Due to Potential Media Breach

    Medtronic is recalling 148 Affinity Pediatric Arterial Filters because a small breach in the filter media may allow unwanted particulate or gaseous emboli to pass through, posing a risk of serious injury or death to pediatric patients.

    Product
    Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatric Arterial Filters are single-use, sterile…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1902-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical Corporation is recalling Nova Max Glucose Test Strips due to reports of false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1904-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings, potentially affecting diabetes management.

    Product
    Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1906-2013·2013-08-21

    Nova Max Plus Monitor System Recalled for False High Glucose Readings

    Nova Biomedical is recalling Nova Max Plus Monitor Systems because test strips may produce false abnormally high glucose readings.

    Product
    Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1901-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max…
    Category
    Medical Device
    Distribution
    Distributed nationwide