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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

25701–25725 of 27722

  • HighFDA (Devices)·Z-0618-2014·2014-01-08

    Stryker S3 Med/Surg Bed Recall for Foot End Cover Damage

    Stryker is recalling S3 Med/Surg beds due to potential damage to the Foot End Cover and Power Coil Cable caused by reduced clearance.

    Product
    S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0534-2014·2014-01-01

    CareFusion Recalls Alaris PC Units Due to System Error Messages

    CareFusion is recalling Alaris PC units because they may produce audible alarms and display System Error messages.

    Product
    Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0531-2014·2014-01-01

    C.L.R. Medicals Recalls Viscocel Intraocular Fluid Devices for Regulatory Deficiencies

    C.L.R. Medicals International is recalling Viscocel and Viscocel Plus intraocular fluid devices due to FDA inspection findings of quality system deficiencies and lack of Premarket Approval.

    Product
    Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2014·2014-01-01

    B. Braun IV Catheters Recalled for Missing Safety Clip

    B. Braun Medical is recalling 55,200 Introcan Safety IV Catheters because one lot may lack the anti-needlestick safety clip.

    Product
    B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2014·2014-01-01

    Varian Eclipse Treatment Planning System Software Deficiency Recall

    Varian Medical Systems is recalling Eclipse Treatment Planning System software due to a defect that may cause Monitor units to change unexpectedly during dose parameter adjustments.

    Product
    Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0556-2014·2014-01-01

    McKesson Radiology 12.0 PACS Recall for Missing Contrast Allergy Data

    McKesson Information Solutions LLC is recalling McKesson Radiology 12.0 PACS because merging patient records may result in missing contrast allergy information.

    Product
    McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0581-2014·2014-01-01

    Smith & Nephew Recalls Reflection Acetabular Liners Due to Tolerance Issues

    Smith & Nephew is recalling 38 units of Reflection acetabular liners because they may be out of tolerance and fail to fully seat into the shell.

    Product
    REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0578-2014·2014-01-01

    Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports

    Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.

    Product
    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0580-2014·2014-01-01

    EOS Imaging Recalls steroEOS Workstation Due to Data Copying Error

    EOS Imaging is recalling 36 steroEOS Workstation units because a software error may prevent 3D model data from copying to clinical files and reports.

    Product
    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2014·2014-01-01

    Philips HeartStart MRx Defibrillator Recall for EtCO2 Display Error

    Philips is recalling HeartStart MRx defibrillators because they display a question mark instead of a value when patient CO2 levels fall below 7.6 mmHg.

    Product
    Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2014·2014-01-01

    Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports

    Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.

    Product
    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0572-2014·2014-01-01

    Trinity Biotech Recalls Captia Syphilis-G Test Kits Due to False Negatives

    Trinity Biotech is recalling Captia Syphilis-G Test Kits because they may produce false negative results for syphilis antibodies.

    Product
    Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum (…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2014·2014-01-01

    Stryker Orthopaedics Ball Impactor Tip Recalled for Cracks and Fractures

    Stryker Howmedica Osteonics Corp. is recalling Ball Impactor Tips used in surgery due to complaints of cracks and fractures.

    Product
    Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2014·2014-01-01

    Stryker Orthopaedics Recalls Rim Impactor Tips Due to Cracks and Fractures

    Stryker Howmedica Osteonics Corp. is recalling 1,690 Rim Impactor Tips used in MDM surgery due to complaints of cracks and fractures.

    Product
    Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2014·2014-01-01

    Siemens Dimension Chemistry Wash Recalled for Result Shifts

    Siemens is recalling Dimension Chemistry Wash lots that may cause shifts in QC and patient sample results for specific tests.

    Product
    Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0488-2014·2013-12-25

    Nephros SafeShower and SafeSpout Water Filters Recalled for Marketing Violations

    Nephros Inc. is recalling SafeShower and SafeSpout water filters because promotional materials marketed them as medical devices.

    Product
    1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0485-2014·2013-12-25

    Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Results

    Abbott Diabetes Care is recalling specific lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.

    Product
    FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0472-2014·2013-12-25

    GE Healthcare Recalls Multi Absorber Original Devices Due to Air Leakage

    GE Healthcare is recalling Multi Absorber Original, Disposable devices due to a potential safety issue involving air leakage associated with the CO2 Multi Absorber.

    Product
    Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0487-2014·2013-12-25

    Nephros SafeSpout Water Filters Recalled for Improper Medical Device Marketing

    Nephros Inc. is recalling SafeSpout water filters because promotional materials made claims that marketed the non-medical products as medical devices.

    Product
    Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0540-2014·2013-12-25

    Smiths Medical Recalls Medfusion 4000 Syringe Infusion Pumps for Electrical Shorting

    Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps because conductive fluids entering the AC power receptacle can cause electrical shorting, sparking, or flames.

    Product
    Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0486-2014·2013-12-25

    Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Low Results

    Abbott Diabetes Care is recalling certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.

    Product
    FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0490-2014·2013-12-25

    Nephros Dual Stage Ultra Filter Brochure Recalled for Misleading Medical Claims

    Nephros Inc is recalling brochures for its Dual Stage Ultra Filter because the materials promoted the product as a medical device.

    Product
    Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2014·2013-12-25

    Baxter ABACUS TPN Calculation Software Recalled for Data Corruption Risk

    Baxter is voluntarily correcting ABACUS TPN software versions 2.0-3.0 because data corruption could cause patients to receive another patient's TPN order.

    Product
    ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2014·2013-12-25

    Remel Inc. Recalls Streptex Latex D Reagent for False Negative Results

    Remel Inc. is recalling 109 kits of Streptex Latex D reagent because the product may produce weak or false negative test results for streptococcal group D.

    Product
    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide