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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39951–39975 of 40356

  • HighFDA (Devices)·Z-2193-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2189-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2197-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2012·2012-08-22

    Carestream DRX-1 System Battery Recall for Overheating Risk

    Carestream Health is recalling DRX-1 system batteries manufactured before June 2012 due to two reported instances of lithium-ion battery overheating that may cause burns.

    Product
    Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2012·2012-08-22

    Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors Due to Fractures

    Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures. The recall affects units manufactured from 455 stainless steel.

    Product
    00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2012·2012-08-22

    Maquet Pediatric Arterial Cannula Recall for Limited Flexibility

    Maquet Inc. is recalling certain pediatric arterial cannulas because the hardened tip may be too long, limiting flexibility during extracorporeal circulation procedures.

    Product
    Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2188-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2200-2012·2012-08-22

    Nico BrainPath Sheaths Recalled for Incorrect Length Labeling

    Nico Corp. is recalling 20 BrainPath sheaths because 50mm units were mislabeled as 60mm, creating a risk of improper fit during use.

    Product
    13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2184-2012·2012-08-22

    AGFA IMPAX Cardiovascular Reporting Software Recalled for Missing Report Data

    AGFA Corp. is recalling IMPAX Cardiovascular Reporting software because user-entered conclusions were not printed on final reports.

    Product
    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2217-2012·2012-08-22

    DePuy Orthopaedics Recalls Unimplanted Custom Implant Devices

    DePuy Orthopaedics is retrieving 8,338 custom implant devices that were ordered but not implanted, following an FDA Warning Letter.

    Product
    DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product Usage: Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2201-2012·2012-08-22

    Nico BrainPath Sheath Recall Due to Incorrect Length Labeling

    Nico Corp. is recalling 15 BrainPath sheaths because 50mm units were mislabeled as 60mm, causing improper fit.

    Product
    13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2187-2012·2012-08-22

    Zimmer Recalls NCB Polyaxial Locking Plate System NCB Screws Due to Incorrect Size

    Zimmer, Inc. is recalling 26mm NCB Polyaxial Locking Plate System screws because a lot contained incorrect 32mm screws.

    Product
    The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2209-2012·2012-08-22

    Roche Recalls COBAS AmpliPrep Sample Tube Input Barcode Clips

    Roche Molecular Systems is recalling certain lots of COBAS AmpliPrep barcode clips because they can cause sample tubes to stick, leading to aborted instrument runs.

    Product
    COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2211-2012·2012-08-22

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products DGXN Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products DGXN Slides because the Instructions for Use were revised to remove heparin plasma as a recommended specimen type.

    Product
    VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2183-2012·2012-08-22

    Beauty Angel Device Recalled for Lack of FDA Clearance

    JK Products & Services is recalling Beauty Angel devices because they were marketed without the required FDA 510(k) clearance.

    Product
    BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2199-2012·2012-08-22

    SenTec Recalls V-Sign 2 Sensors Due to Configuration Parameter Writing Errors

    Sentec AG is recalling V-Sign 2 Sensors because of a problem with configuration parameter writing during manufacturing.

    Product
    SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2186-2012·2012-08-22

    Teleflex Medical Recalls TAUT Cholangiogram Catheter Intraducer Due to Missing Label

    Teleflex Medical is recalling 611 units of TAUT Cholangiogram Catheter Intraducers because the internal packaging is missing labels. The devices were distributed to 27 states.

    Product
    TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body.
    Category
    Medical Device
    Distribution
    26 states
  • LowFDA (Devices)·Z-2218-2012·2012-08-22

    Terumo Sarns System 8000 Base Recalled for Incorrect Amperage Labeling

    Terumo is recalling three Sarns System 8000 bases because they were distributed with incorrect amperage ratings on the nameplate labels.

    Product
    System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2216-2012·2012-08-22

    Sunquest Laboratory SMART Software Recalled for Test Result Filing Errors

    Sunquest Information Systems is recalling Sunquest Laboratory SMART software versions 6.3.0 and later because test results may be filed to the wrong patient containers.

    Product
    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2136-2012·2012-08-15

    GE OEC Medical Systems Recalls FluoroTrak Spinal Navigation Application

    GE OEC Medical Systems is recalling 17 FluoroTrak Spinal Navigation Applications because they may display incorrect instrument positions relative to reference images.

    Product
    Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a…
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2182-2012·2012-08-15

    Siemens Dimension Reagent Management System Power Cord Recall

    Siemens Healthcare Diagnostics is recalling 2,554 Dimension Reagent Management System power cords due to a fire hazard caused by partial cord insertion.

    Product
    Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test…
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-2155-2012·2012-08-15

    Stryker Luxor Retractor Base Recalled Due to Blade Disassembly

    Stryker Spine is recalling 30 Luxor Retractor Base devices because blades may disassemble from the base, causing the retractor to collapse during use.

    Product
    LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a…
    Category
    Medical Device
    Distribution
    0 states