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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39051–39075 of 40449

  • HighFDA (Devices)·Z-0674-2013·2013-01-23

    Philips Recalls Brilliance 64 and Ingenuity CT Scanners Due to Software Anomalies

    Philips Medical Systems is recalling nine CT scanning systems due to software anomalies that could pose a risk of injury to patients and personnel if the issues recur.

    Product
    Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0669-2013·2013-01-23

    Terumo Recalls Sarns High-Flow Aortic Arch Cannulas Due to Connector Flash

    Terumo is recalling Sarns high-flow aortic arch cannulas because connector flash may detach during surgery.

    Product
    Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2013·2013-01-23

    Terumo Recalls Sarns High-Flow Aortic Arch Cannulas Due to Connector Flash

    Terumo is recalling Sarns High-Flow Aortic Arch Cannulas and Flexible Arterial Cannulae because connector flash may detach during surgery.

    Product
    Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2013·2013-01-23

    Perkinelmer Recalls Defective Truncated V-Bottomed Microplates

    Perkinelmer is recalling specific lots of truncated V-bottomed microplates because the wells are defective. These products are used for preparing and examining human body specimens.

    Product
    Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2013·2013-01-23

    Terumo Recalls Sarns Flexible Arterial Cannulas Due to Connector Flash

    Terumo Cardiovascular Systems is recalling Sarns flexible arterial cannulas and high-flow aortic arch cannulas because the connectors contain flash that may detach during surgery.

    Product
    Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2013·2013-01-23

    Stryker Recalls Hoffman LRF Wire Bolts Due to Breakage During Use

    Stryker Howmedica Osteonics is recalling 476 Hoffman LRF Wire Bolts because two complaints reported the wires broke during load-bearing application by patients.

    Product
    Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0666-2013·2013-01-23

    Terumo Recalls Sarns Arterial Cannulas Due to Connector Flash

    Terumo is recalling Sarns flexible arterial cannulas and high-flow aortic arch cannulas because connector flash may detach during surgery.

    Product
    Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0671-2013·2013-01-23

    Terumo Recalls Sarns Aortic Arch Cannulas Due to Connector Flash

    Terumo is recalling Sarns high-flow aortic arch and flexible arterial cannulas because connector flash may detach during surgery.

    Product
    Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns" High Flow Aortic Arch Cannula and Sarns&quot…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0694-2013·2013-01-23

    Spacelabs Smart Disclosure System Recalled for Incorrect Waveform Display

    Spacelabs Healthcare is recalling the Smart Disclosure System, Model 92810, because it may display or print incorrect patient waveforms for the indicated time.

    Product
    Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0668-2013·2013-01-23

    Terumo Sarns Arterial Cannulas Recalled for Connector Flash Defect

    Terumo is recalling Sarns flexible arterial and high-flow aortic arch cannulas because exterior flash on the connectors may detach during surgery.

    Product
    Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2013·2013-01-23

    DePuy Spine EXPEDIUM Offset Torque Wrench Recalled for Wear

    DePuy Spine is recalling 140 EXPEDIUM Offset Torque Wrenches because a handle component wears prematurely, potentially causing inaccurate torque readings.

    Product
    DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0688-2013·2013-01-23

    Perkinelmer Recalls Neonatal Total Galactose Kits Due to Defective Microplate Wells

    Perkinelmer is recalling Neonatal Total Galactose Kits because the microplate wells used in the assays are defective, which may affect the accuracy of newborn screening results.

    Product
    NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0691-2013·2013-01-23

    Quanta System Q-Plus T Laser Recall for Promotional Material Labeling

    Quanta System is recalling 75 Q-Plus T laser units because promotional materials on their website did not specify that certain claims did not apply to U.S. distributed devices.

    Product
    Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0686-2013·2013-01-23

    Perkinelmer Recalls Defective NEOGRAM Tandem Mass Spectrometry Kits

    Perkinelmer is recalling 180 NEOGRAM Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kits because they contain defective microplate wells.

    Product
    NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0689-2013·2013-01-23

    Perkinelmer Recalls Defective DBS Microplates for Assay Use

    Perkinelmer is recalling 56 kits of DBS Microplates, Truncated V-Bottomed, due to defective wells that may affect assay results.

    Product
    DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0693-2013·2013-01-23

    Quanta System Laser Surgical Instrument Recall for Promotional Material Claims

    Quanta System is recalling 22 laser surgical instruments because website promotional materials contained claims not applicable to US devices.

    Product
    Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0697-2013·2013-01-23

    IDS Recalls 25-Hydroxy Vitamin D EIA Due to QC Error

    IDS is recalling 25-Hydroxy Vitamin D EIA kits because a quality control report contained an incorrect calibrator value.

    Product
    25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0675-2013·2013-01-23

    Philips CT System Software Recall for Coronary Artery Labeling Defect

    Philips is recalling 108 CT systems because a software defect prevents users from labeling coronary arteries in rendered images.

    Product
    Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by…
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0692-2013·2013-01-23

    Quanta System Laser Recall for Inaccurate Promotional Website Claims

    Quanta System is recalling 12 Eterna Giovinezza laser units because its website contained promotional materials with claims not applicable to U.S. distributed devices.

    Product
    Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0681-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0679-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling specific lots of GranuFlo Dry Acid Concentrate because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0677-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0682-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate due to potential discoloration. The product is used for hemodialysis treatment.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0676-2013·2013-01-23

    Fresenius GranuFlo Dry Acid Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0678-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 14,240 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide