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

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Minimum severity

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

Clear filters

29751–29775 of 40325

  • ModerateFDA (Devices)·Z-2110-2016·2016-07-06

    Philips Big Bore Radiology Scanner Recalled for Incorrect Screw Material

    Philips is recalling 89 Big Bore Radiology scanners because adjustment plate screws were made of stainless steel instead of the specified alloy steel.

    Product
    Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2117-2016·2016-07-06

    Philips Ingenuity Core CT Systems Recalled for Image Artifacts

    Philips is recalling 18 Ingenuity Core CT systems because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.

    Product
    Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2112-2016·2016-07-06

    Philips Brilliance iCT Scanner Recall Due to Cracking Cover

    Philips is recalling Brilliance iCT scanners because a design change resulted in a thinner plastic cover that may crack.

    Product
    Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2107-2016·2016-07-06

    Siemens Recalls SYNGO Breast Care Software Due to Display Issues

    Siemens is voluntarily recalling 29 units of SYNGO Breast Care software because patient information can obscure view markers and facility details are not shown by default.

    Product
    SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2084-2016·2016-07-06

    Integra LifeSciences Recalls METASURG Capture Screw System K-wires

    Integra LifeSciences is recalling 182 K-wires used in the METASURG Capture Screw System because they do not meet material, surface, and dimensional specifications.

    Product
    K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2016·2016-07-06

    Integra LifeSciences Recalls Cadence Tibial Tray Implant Due to Labeling Error

    Integra LifeSciences is recalling 12 units of the Cadence Size 5 Left Tibial Tray Implant because the outer package label incorrectly identifies the material as Cobalt Chromium instead of Titanium.

    Product
    Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2116-2016·2016-07-06

    Philips Brilliance 64 CT Scanner Recall for Image Artifacts

    Philips is recalling 94 Brilliance 64 CT scanners due to intermittent swirl-like ring artifacts on images, which may require patient rescans.

    Product
    Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2109-2016·2016-07-06

    Philips Big Bore Oncology Scanner Recalled for Incorrect Screw Material

    Philips is recalling 47 Big Bore Oncology scanners because the socket head cap screws in the Z-Axis Adjustment Plate were made of stainless steel instead of the specified alloy steel.

    Product
    Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2051-2016·2016-07-06

    Cardiovascular Systems Recalls ViperWire Advance Peripheral Guide Wire Due to Missing Date

    Cardiovascular Systems Inc is recalling ViperWire Advance Peripheral Guide Wire because the pouch label was missing the use-by date.

    Product
    ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2016·2016-06-29

    Immuno-Mycologics Recalls Histoplasma Yeast Complement Fixation Antigen Due to Bacterial Contamination

    Immuno-Mycologics, Inc. is recalling 467 units of Histoplasma Yeast Complement Fixation Antigen Dilute (Lot 111WH3) due to bacterial contamination. The product was distributed nationwide to specific states.

    Product
    Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2017-2016·2016-06-29

    Siemens Biograph PET/CT Scanner Upgrade Recalled for Calibration Error

    Siemens Medical Solutions is recalling 2 Biograph TruePoint scanner upgrades because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2016·2016-06-29

    Fresenius CLiC Monitor Recall for Potential Hemodialysis Pump Stoppage

    Fresenius Medical Care is recalling 875 CLiC monitors used with 2008T hemodialysis machines because a frozen screen may cause the blood pump to stop.

    Product
    Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2016·2016-06-29

    Siemens Biograph mCT-X 4R PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 83 Biograph mCT-X 4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2016·2016-06-29

    Fujifilm Synapse PACS Software Recall for Image Display Failure

    Fujifilm Medical Systems is recalling 27 units of Synapse PACS software versions 4.4.000 through 4.4.020 because the software fails to display medical images, showing an error message instead.

    Product
    Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2031-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error

    Siemens Medical Solutions is recalling 100 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2042-2016·2016-06-29

    Surgical Specialties Recalls Sharpoint Polypropylene Suture Due to Contamination

    Surgical Specialties Corporation is recalling Sharpoint Polypropylene Blue Monofilament 9-0 USP suture because it may contain Black Nylon 9-0 suture.

    Product
    Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2009-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 46 Biograph 40 TruePoint PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2046-2016·2016-06-29

    Implant Direct Recalls InterActive Implant Open-Tray Transfers Due to Sizing Error

    Implant Direct is recalling 48 units of InterActive Implant Open-Tray Transfers because the wrong size was packaged, which may lead to oversized crown fabrication.

    Product
    6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2034-2016·2016-06-29

    Siemens Biograph mCT-X 3R PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 22 Biograph mCT-X 3R PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2006-2016·2016-06-29

    Siemens Biograph 16 TruePoint TV Recall for Calibration Error

    Siemens is recalling 36 Biograph 16 TruePoint TV scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2038-2016·2016-06-29

    Cell Marque Recalls SIOOA I Rabbit Monoclonal Antibody Lots

    Cell Marque is recalling specific lots of SIOOA I Rabbit Monoclonal Antibody due to unacceptable IHC test results. The affected units were distributed in the US and several international countries.

    Product
    SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2013-2016·2016-06-29

    Siemens Biograph 64 PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 15 Biograph 64 PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2037-2016·2016-06-29

    Siemens Biograph 16 TruePoint PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 63 Biograph 16 TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2030-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 47 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2035-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens Medical Solutions is recalling four Biograph TruePoint PET/CT scanners due to a risk of unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide