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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18576–18600 of 40124

  • HighFDA (Devices)·Z-0787-2020·2020-01-15

    Intersurgical Airway Connector Recalled for Potential Swivel Elbow Cracking

    Intersurgical Inc is recalling 50,400 airway connectors because the swivel elbow port may crack and leak. The recall covers products distributed nationwide in the US.

    Product
    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2020·2020-01-15

    Implant Direct IO Scan Adapter Recall Due to Loose Component

    Implant Direct Sybron Manufacturing is recalling 232 IO Scan Adapters because a loose part could fall into a patient's mouth, causing aspiration or ingestion.

    Product
    ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0781-2020·2020-01-15

    Stryker Pin To Rod Coupling Recalled for Clamping Failure

    Stryker is recalling Pin To Rod Couplings for the Hoffmann II Compact External Fixation System because they may fail to clamp the pin and rod as intended.

    Product
    Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2020·2020-01-15

    Intersurgical Airway Connector Recalled for Potential Swivel Elbow Cracking

    Intersurgical Inc is recalling 19,200 airway connectors because the swivel elbow port may crack and leak.

    Product
    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0783-2020·2020-01-15

    Abbott Fast-Cath Trio Hemostasis Introducer Recalled for Incorrect Size

    Abbott Medical is recalling 814 Fast-Cath Trio Hemostasis Introducer devices because they contain 12F components instead of the expected 14F size.

    Product
    Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0792-2020·2020-01-15

    Cochlear Baha 5 Sound Processor Battery Door Recall

    Cochlear Americas Inc. is recalling 50 units of Baha 5 Sound Processor Tamper Proof Battery Doors packaged with the incorrect component.

    Product
    Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0776-2020·2020-01-15

    Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy

    Nextremity Solutions is recalling 87 Stratum MDS Screws because they are 2mm shorter than the length indicated on the package label.

    Product
    Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0777-2020·2020-01-15

    Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy

    Nextremity Solutions is recalling 86 Stratum MDS Screws because the components are 2mm shorter than indicated on the package label.

    Product
    Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0779-2020·2020-01-15

    Medical Action Industries Recalls Medical Convenience Kits Due to Saline pH Defect

    Medical Action Industries is recalling 9,924 cases of medical convenience kits because the included saline solution may exceed USP pH requirements.

    Product
    Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B ***PEDS CVC*** Clear Sequence Change Kit, REF 77190B ***PICC*** Clear Sequence Change Kit…
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-0778-2020·2020-01-15

    Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy

    Nextremity Solutions is recalling 86 Stratum MDS Screws because they are 2mm shorter than the length indicated on the package label.

    Product
    Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0794-2020·2020-01-15

    Baxter Recalls One-Link Needle-Free IV Connectors Due to Connection Force Issue

    Baxter Healthcare is recalling One-Link Needle-Free IV Connectors because some units require higher-than-expected force to connect securely to standard Luer adapters.

    Product
    ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Product Usage: intended for single patient use with a vascular access device for the administration of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0746-2020·2020-01-08

    Thoratec HeartMate 3 Mobile Power Unit Recalled for Static Electricity Risk

    Thoratec Corp. is recalling HeartMate 3 Mobile Power Units because excessive static electricity can cause unrecoverable power loss, potentially reducing blood flow from the left ventricular assist system.

    Product
    HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0765-2020·2020-01-08

    Villa Sistemi Medicali Recalls Apollo DRF X-ray Tables Due to Chain Failure

    Villa Sistemi Medicali is recalling seven Apollo DRF X-ray tables because the angulation chain may fail early due to metal fatigue.

    Product
    Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0766-2020·2020-01-08

    Villa Sistemi Medicali Recalls Apollo EZ X-Ray Table Due to Chain Failure

    Villa Sistemi Medicali is recalling one Apollo EZ X-ray table because the angulation chain may fail early due to metal fatigue.

    Product
    Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring System Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 318,678 units distributed in the US and 35 other countries.

    Product
    Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2020·2020-01-08

    Carl Zeiss PLEX Elite 9000 Recalled for Electrical Shock Hazard

    Carl Zeiss Meditec is recalling 151 PLEX Elite 9000 Swept-Source OCT devices because a design fault may expose operators to hazardous voltage when contacting the metal enclosure.

    Product
    The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2020·2020-01-08

    Medicrea Polyaxial Pedicle Screws Recalled Due to Incorrect Length

    Medicrea International is recalling 210 polyaxial pedicle screws that are 50mm long instead of the labeled 45mm, posing a risk of nerve contact and postoperative pain.

    Product
    Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0772-2020·2020-01-08

    Nucletron Flexitron Brachytherapy Afterloader Recalled for Cable Guide Failure

    Nucletron BV is recalling 383 Flexitron brachytherapy afterloader systems due to a component failure that may cause treatment interruption or incorrect source positioning.

    Product
    There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0748-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues that may affect device performance.

    Product
    Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 452,392 units distributed in the US and internationally.

    Product
    Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2020·2020-01-08

    Villa Sistemi Medicali Recalls Apollo X-ray Tables Due to Chain Failure Risk

    Villa Sistemi Medicali is recalling three Apollo X-ray tables because the angulation chain may fail early due to metal fatigue.

    Product
    Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0763-2020·2020-01-08

    Villa Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Chain Failure

    Villa Sistemi Medicali is recalling 46 Juno DRF x-ray systems because the angulation chain may fail early due to metal fatigue.

    Product
    Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2020·2020-01-08

    Medtronic Recalls O-arm O2 Imaging Systems Due to Belt Loosening

    Medtronic is recalling 90 O-arm O2 Imaging Systems because a manufacturing issue may cause the gantry tractor motor drive belt to loosen, potentially rotating 3D images relative to the patient's physical position.

    Product
    O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0749-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Meters Due to Power Issues

    Roche Diabetes Care is recalling 21,094 Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall covers units distributed in the US and 34 other countries.

    Product
    Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper…
    Category
    Medical Device
    Distribution
    Distributed nationwide