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

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36176–36200 of 40449

  • 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
  • HighFDA (Devices)·Z-1225-2014·2014-03-26

    Philips HeartStart FR3 AED Recalled for Potential Circuit Board Separation

    Philips is recalling HeartStart FR3 AEDs because the circuit board may separate, preventing the device from delivering a shock during an emergency.

    Product
    Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support…
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1232-2014·2014-03-26

    Philips Recalls HeartStart Home and OnSite AEDs Due to Solder Residue

    Philips is recalling HeartStart Home and OnSite AEDs because solder residue may prevent the device from delivering therapy in an emergency.

    Product
    Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2014·2014-03-26

    Elekta Linear Accelerators Recalled for Default Value Reset Issues

    Elekta, Inc. is recalling SL & SLi Series linear accelerators because customers are resetting default values outside recommended factory settings.

    Product
    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2014·2014-03-26

    Convatec SLC Foley Catheters Recalled for Blocked Lumens

    Convatec Inc. is recalling 5,540 SLC 2-way Foley catheters because excess lubricious coating material was found blocking the lumen.

    Product
    SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: 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-1266-2014·2014-03-26

    Otto Bock Recalls Aerial Wheelchair Cushions Due to Flammability Risk

    Otto Bock is recalling Aerial and Aerial Active wheelchair cushions because internal testing found a small risk of flammability after high-temperature washing.

    Product
    Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2014·2014-03-26

    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, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating 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…
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1240-2014·2014-03-26

    Convatec Recalls Toray Hydrocoat Foley Catheters Due to Blocked Lumen

    Convatec Inc. is recalling 54,590 Toray Hydrocoat Foley Catheters because the drainage lumen was found to be blocked by excess lubricious coating material.

    Product
    'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x 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…
    Category
    Medical Device
    Distribution
    1 state