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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25276–25300 of 27722

  • HighFDA (Devices)·Z-1289-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports

    Teleflex Medical is recalling 55,521 Weck Vista Universal Balloon Open Access Ports due to gas leakage that may delay laparoscopic surgeries.

    Product
    5/10/12 Weck¿ Vista" Universal Balloon Open Access Port  Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2014·2014-04-02

    Medtronic Recalls FiberNet Embolic Protection System Due to Manufacturing Defect

    Medtronic is recalling specific lots of the FiberNet Embolic Protection System because a yellow polyimide tube was not removed during manufacturing.

    Product
    FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1306-2014·2014-04-02

    Abbott i-STAT G3+ Cartridge Recall for Inaccurate Blood Gas Results

    Abbott Point of Care is recalling i-STAT G3+ Cartridges (Lot N13183) because they may produce incorrectly elevated PCO2 and depressed pH results.

    Product
    i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports

    Teleflex Medical is recalling 55,521 Weck Vista Universal Balloon Open Access Ports due to gas leakage that may delay laparoscopic surgeries.

    Product
    5/10/12 Weck¿ Vista" Universal Balloon Open Access Port  Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2014·2014-04-02

    Synthes Ulna Osteotomy System Drill Template and Saw Guide Recall

    Synthes, Inc. is recalling 343 Drill Templates and Saw Guides for the Ulna Osteotomy System due to potential mechanical failure of connecting screws or K-wires.

    Product
    Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1305-2014·2014-04-02

    Medtronic Recalls FiberNet Embolic Protection System Due to Manufacturing Defect

    Medtronic is recalling specific lots of the FiberNet Embolic Protection System because a yellow polyimide tube was not removed during manufacturing.

    Product
    FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1202-2014·2014-04-02

    Siemens Artis Q X-ray Systems Recalled for Potential Tube Breakdown

    Siemens is recalling 19 Artis Q and Artis Q biplane systems because a breakdown of the x-ray tube could result in loss of x-ray imaging during clinical operation.

    Product
    Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1212-2014·2014-03-26

    Abbott Recalls FreeStyle Flash Blood Glucose Meters Due to Inaccurate Results

    Abbott Diabetes Care is recalling FreeStyle Flash Blood Glucose Monitors because they may produce inaccurate low blood glucose readings when used with specific test strips.

    Product
    FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1211-2014·2014-03-26

    Abbott FreeStyle Blood Glucose Monitors Recalled for Inaccurate Results

    Abbott Diabetes Care is recalling FreeStyle Blood Glucose Monitors because they may produce inaccurate blood glucose readings when used with specific test strips.

    Product
    FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2014·2014-03-26

    Convatec Recalls Latex Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling Curion CuriStay Nelaton latex Foley catheters because the drainage lumen was found blocked by excess lubricious coating material.

    Product
    Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1215-2014·2014-03-26

    Biomet 3i Recalls BellaTek Zirconia Dental Abutments Due to Fracture Reports

    Biomet 3i is recalling BellaTek Zirconia Dental Abutments because of reports of fractures. The recall covers 10,454 units distributed worldwide.

    Product
    Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2014·2014-03-26

    Exactech Recalls Gibralt Spine System Polyaxial Screws Due to Material Error

    Exactech is recalling 242 Gibralt Spine System Polyaxial Screws because they contain springs made of type-304 stainless steel instead of the specified titanium alloy.

    Product
    Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1231-2014·2014-03-26

    Teleflex Recalls Rusch Endobronchial Tubes Due to Cuff Seal Failure

    Teleflex Medical is recalling Rusch Brochopart endobronchial tubes because the cuff may inflate to one side, preventing a proper seal of the right lung.

    Product
    Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1239-2014·2014-03-26

    Convatec Recalls Latex Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling 31,250 latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1213-2014·2014-03-26

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System Recalled

    Mar Cor Purification is recalling 232 Millenium HX Portable Reverse Osmosis Systems due to high inlet water pressure and solenoid valve issues that could delay dialysis treatment.

    Product
    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2014·2014-03-26

    Siemens syngo Dynamics PACS Recalled for Potential Patient Data Mixup

    Siemens is recalling 50 syngo Dynamics PACS units because improper error handling could display images for one patient and reports for another, risking misdiagnosis.

    Product
    syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2014·2014-03-26

    Alere Triage TOX Drug Screen Recalled for False Negative PCP Results

    Alere San Diego, Inc. is recalling specific lots of the Alere Triage TOX Drug Screen because they produce false negative results for PCP more often than stated in the package insert.

    Product
    Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen is a fluorescence immunoassay to be used with the Alere…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2014·2014-03-26

    Convatec Latex Foley Catheters Recalled Due to Blocked Lumen

    Convatec Inc. is recalling 4,760 SLC 3-way standard latex Foley catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1264-2014·2014-03-26

    Philips EPIQ 7 Ultrasound System Recalled for Incorrect Doppler Velocity Readings

    Philips is recalling EPIQ 7 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.

    Product
    Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2014·2014-03-26

    Medical Information Technology Recalls MEDITECH Microbiology Software Due to Erroneous Results

    Medical Information Technology, Inc. is recalling MEDITECH Microbiology software releases 5.6 through 6.14 because of a potential for erroneous result reporting.

    Product
    MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2014·2014-03-26

    Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena…
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1236-2014·2014-03-26

    Medline Sterile Foley Catheter Recalled for Blocked Lumen

    Convatec Inc. is recalling Medline Sterile Foley Catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1218-2014·2014-03-26

    Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena…
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1224-2014·2014-03-26

    Terumo Recalls Sarns Dual-stage Venous Return Cannulae Due to Exposed Wire

    Terumo CVS is recalling Sarns Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.

    Product
    Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass…
    Category
    Medical Device
    Distribution
    15 states