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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29301–29325 of 40449

  • ModerateFDA (Devices)·Z-2624-2016·2016-08-31

    Siemens CT Scanner Recall Due to Contrast Injection Failure

    Siemens is recalling one SOMATOM Definition AS CT scanner because a software error prevents the automatic injection of contrast agent during scans.

    Product
    SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2659-2016·2016-08-31

    Novarad NovaPACS Software Recalled for Prematurely Released Pop-up Screen

    Novarad Corporation is recalling NovaPACS software versions 8.4.7, 8.5.3, and 8.5.6 due to a prematurely released pop-up screen.

    Product
    NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2633-2016·2016-08-31

    Medtronic Alpha Total Knee Replacement Components Recalled for Passivation Defect

    Medtronic is recalling Alpha total knee replacement femoral components that may not have been passivated according to job traveler requirements.

    Product
    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2607-2016·2016-08-31

    Merz Recalls Radiesse Injectable Implant Due to Syringe Delivery Issues

    Merz North America is recalling 1,591 units of Radiesse (+) Lidocaine Injectable Implant because the product could not be expelled from the syringe or needle.

    Product
    Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2600-2016·2016-08-31

    Integra LifeSciences Recalls QWIX Compression Screws Due to Labeling Error

    Integra LifeSciences is recalling QWIX Compression Screws because the product labeling incorrectly identifies them as compression screws rather than positioning screws.

    Product
    Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2654-2016·2016-08-31

    Philips Brilliance BigBore CT Scanner Recalled for Image Reconstruction Error

    Philips is recalling 24 Brilliance BigBore CT scanners because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.

    Product
    Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2606-2016·2016-08-31

    Encore Medical Recalls Cobalt HV Bone Cement Due to Packaging Mislabeling

    Encore Medical is recalling 866 units of Cobalt HV Bone Cement because the outer packaging incorrectly indicated the product contained Gentamicin, an antibiotic it does not contain.

    Product
    Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2601-2016·2016-08-31

    Siemens RAPIDPoint 500 Software Upgrade Kit Recalled for Uncleared Mode

    Siemens is recalling 76 RAPIDPoint 500 software upgrade kits because some include a dialysate mode not cleared for shipment in the United States.

    Product
    Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2533-2016·2016-08-24

    Baxter Recalls VASCU-GUARD Patches Due to Bleeding Reports

    Baxter Healthcare is recalling VASCU-GUARD Peripheral Vascular Patches due to postmarketing reports of intraoperative and postoperative bleeding, including one fatal outcome.

    Product
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2403-2016·2016-08-24

    OraSure Recalls OraQuick Ebola Rapid Antigen Test Due to Stability Failures

    OraSure Technologies is recalling 3,075 units of the OraQuick Ebola Rapid Antigen Test because stability testing revealed intermittent false negative results.

    Product
    OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2567-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Flat L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 119,770 units distributed worldwide.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2575-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 50,055 units distributed worldwide.

    Product
    Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2577-2016·2016-08-24

    Medtronic Recalls Laparoscopic Electrode Due to Sterile Barrier Compromise Risk

    Medtronic is recalling 3,470 Valleylab Laparoscopic Flat L-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2016·2016-08-24

    Medtronic Recalls Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling 1,440 Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2582-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Bodies Due to Fastener Separation Risk

    Synthes (USA) Products LLC is voluntarily recalling 182 units of Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2016·2016-08-24

    Synthes Recalls Titanium Single Vector Distractor Bodies Due to Fastener Separation Risk

    Synthes (USA) Products LLC is voluntarily recalling 90 units of Titanium Single Vector Distractor Bodies because the fastener may separate prematurely from the Proximal Foot Plate.

    Product
    TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2552-2016·2016-08-24

    Reshape Medical Recalls ReShape Integrated Dual Balloon System Due to Assembly Error

    Reshape Medical Inc. is recalling 56 units of the ReShape Integrated Dual Balloon System because a manufacturing assembly error may cause saline leakage during inflation.

    Product
    ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2555-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling 19,200 Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2546-2016·2016-08-24

    Medtronic EnVeo Delivery Catheter System Recalled for Vascular Trauma Risk

    Medtronic is recalling 7,319 EnVeo Delivery Catheter Systems worldwide due to a potential for vascular trauma during use.

    Product
    Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2423-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i is recalling 1,648,273 dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

    Product
    LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Argon Modified Flat l Electrodes due to a potential sterile barrier breach.

    Product
    Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 63,320 units distributed worldwide.

    Product
    Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2570-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers lots 209358X through 60870083X distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2016·2016-08-24

    TYRX Neuro Absorbable Antibacterial Envelope Recalled for Manufacturing Validation Issues

    TYRX Inc. is recalling 194 units of the TRYX Neuro Absorbable Antibacterial Envelope because manufacturing processes were not adequately validated.

    Product
    TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
    Category
    Medical Device
    Distribution
    Distributed nationwide