The Recall Desk

State

California product recalls

20,199 recalls have nationwide distribution and so reach California. 0 additional recalls listed California specifically in their distribution scope.

About recalls in California

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect California consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

9876–9900 of 20199

  • HighFDA (Devices)·Z-1242-2024·2024-03-13

    Synthes Opal Intervertebral Cage Spinal Implant Recall: Sterility Not Confirmed

    Synthes is recalling 30 Opal intervertebral cage spinal implants (Lot 427P153) because sterility cannot be confirmed. Patients with these devices should contact their surgeon immediately.

    Product
    Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2024·2024-03-13

    Triathlon TS Plus tibial inserts recalled for potential packaging breaches

    Howmedica Osteonics Corp. is recalling Triathlon TS Plus tibial inserts due to potential breaches in sterile packaging that could compromise product sterility. Affected units were distributed nationwide and internationally.

    Product
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2024·2024-03-13

    Medical imaging software measurements incorrect in specific cases

    FUJIFILM's Synapse PACS Version 7.2.200 produces incorrect measurements when analyzing certain breast imaging scans without pixel spacing data. This measurement error could affect diagnostic accuracy.

    Product
    Synapse PACS - Version 7.2.200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2024·2024-03-13

    Aesculap Disposable Trocar with Dilating Pin Recalled for Compromised Sterility

    Aesculap Inc is recalling Disposable Trocars with Dilating Pins (Product Code EK224SU) due to potentially damaged sterile blister packaging that may compromise sterility. Affected units were distributed in the US and Canada.

    Product
    DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1265-2024·2024-03-13

    FDA Recalls Tibial Inserts Due to Potential Sterile Packaging Breach

    Howmedica Osteonics is recalling tibial inserts due to potential breaches in sterile packaging. The breach could allow device contamination and increase post-operative infection risk.

    Product
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2024·2024-03-13

    MRI System Spatial Field Gradient Values Incorrectly Displayed and Documented

    Vantage Titan MRI systems display and document spatial field gradient values that are lower than correct, which may cause discomfort in patients with MR-conditional devices.

    Product
    Vantage Titan, Model: MRT-1504
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1251-2024·2024-03-13

    Invacare Homecare and G-Series Bed Components Recalled for Weld Defects

    Invacare Corporation is recalling approximately 8,117 bed component units nationwide due to a potential weld defect that may cause premature weld failure.

    Product
    Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2024·2024-03-13

    Synthes 1.5MM Surgical Drill Bit Recalled Due to Sterilization Concerns

    Synthes has recalled 17 units of 1.5MM surgical drill bits worldwide because the products could not be confirmed as sterilized, posing an infection risk during orthopedic procedures.

    Product
    1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1249-2024·2024-03-13

    MRI System Displays Incorrect Field Gradient Safety Values

    Canon Medical's Vantage Elan MRI system may display incorrect maximum Spatial Field Gradient values, potentially causing discomfort in patients with MR conditional devices.

    Product
    MRI system: Vantage Elan, Model: MRT-2020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2024·2024-03-13

    Medical Device: VITROS 3600 immunodiagnostic system software defect may produce incorrect results

    A software defect in the VITROS 3600 Immunodiagnostic System may cause quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient test results.

    Product
    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2024·2024-03-13

    Automated medication dispensing cabinets may randomly freeze, crash, or hang

    BD Pyxis automated dispensing cabinets with affected software may randomly hang, freeze, or crash, potentially delaying medication access and causing data loss. Approximately 20,443 units are affected worldwide.

    Product
    BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2024·2024-03-13

    Synthes 2.5MM Surgical Drill Bits Recalled Due to Unconfirmed Sterility

    Synthes (USA) Products LLC is recalling 30 units of 2.5MM sterile surgical drill bits (Lot 77P6506) because sterility cannot be confirmed. Non-sterile surgical instruments pose a risk of surgical site infection if used in orthopedic procedures.

    Product
    2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2024·2024-03-13

    Synapse PACS version 7.3.000 produces incorrect breast imaging measurements

    FUJIFILM's Synapse PACS version 7.3.000 software produces incorrect measurements when secondary capture images without pixel spacing are combined with breast tomosynthesis series. No illnesses or injuries reported.

    Product
    Synapse PACS - Version 7.3.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2024·2024-03-13

    Apollo Onyx Delivery Microcatheter recalled for incorrect indications for use

    Micro Therapeutics is recalling Apollo Onyx Delivery Microcatheter devices with incorrect indications for use. European-version devices were distributed in the U.S. across 29 states.

    Product
    The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2024·2024-03-13

    Synthes RIA Tube Assembly Recalled for Unconfirmed Sterility

    Synthes is recalling 144 units of RIA Tube Assembly surgical instruments due to sterility failure. The devices cannot be confirmed as sterile and pose a risk of infection if used in orthopedic procedures.

    Product
    RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2024·2024-03-13

    Synapse PACS Software Version 7.2.000 Measurement Error in Breast Imaging

    FUJIFILM's Synapse PACS Version 7.2.000 produces incorrect measurements in breast imaging when analyzing Secondary Capture 2D images lacking pixel spacing information. Affected healthcare facilities should discontinue use for breast imaging measurements.

    Product
    Synapse PACS - Version 7.2.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2024·2024-03-13

    FUJIFILM Synapse PACS Software Produces Incorrect Breast Imaging Measurements

    FUJIFILM is recalling Synapse PACS Version 7.2.100 because the medical imaging software produces incorrect measurements when analyzing certain breast images. Affected healthcare facilities using this software version should verify measurement accuracy in their systems.

    Product
    Synapse PACS - Version 7.2.100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2024·2024-03-13

    Titanium Hindfoot Arthrodesis Cannulated Nails Recalled Due to Sterilization Failure

    Synthes recalls 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails (5 units) due to failed sterilization. These surgical implants were distributed worldwide and pose infection risk if implanted.

    Product
    13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2024·2024-03-13

    Orthopedic knee implant recalled for potential sterile packaging breaches

    Howmedica Osteonics Corp. is recalling the NO 3 Triathlon TS Plus Tibial Insert due to potential breaches in the sterile packaging. The breaches could compromise product sterility and safety.

    Product
    NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2024·2024-03-13

    Laboratory analyzer software defect may cause erroneous patient test results

    A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient results.

    Product
    VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2024·2024-03-13

    Laboratory chemistry system software defect impairs quality control reporting

    A software defect in VITROS XT 3400 Chemistry Systems prevents quality control rules from properly reporting failures in test controls. This may result in erroneous patient test results being reported.

    Product
    VITROS XT 3400 Chemistry System, Catalog No. 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1248-2024·2024-03-13

    MRI Systems Show Incorrect Spatial Field Gradient Values

    Canon Medical's MRI systems display incorrect Spatial Field Gradient values that are lower than actual, which may cause discomfort for patients with MR-conditional implanted devices during scanning.

    Product
    MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0367-2024·2024-03-13

    Mercaptopurine Tablets Recalled Due to Failed Dissolution Specifications

    Stason Pharmaceuticals recalls Mercaptopurine Tablets, USP 50 mg due to failed dissolution specifications at 9 months. Dissolution results were slightly below the required specification.

    Product
    Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0365-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled due to defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling Clindamycin Phosphate Topical Solution 1% due to defective containers with slow leakage. Lot 119874 (expires 06/30/2025) distributed nationwide in the U.S. and Puerto Rico is affected.

    Product
    Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
    Category
    Drug
    Distribution
    Distributed nationwide