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 deaths or serious injuries are reported, 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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951–975 of 13464

  • HighFDA (Devices)·Z-1343-2026·2026-02-18

    Alphatec ATEC Lateral Navigation Disc Prep Instruments recalled for design defect

    Alphatec Spine, Inc. is recalling ATEC Lateral Navigation Disc Prep Instruments due to a design issue affecting the navigated array connection geometry. These surgical instruments may not function properly during spine surgery procedures.

    Product
    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2026·2026-02-18

    Medline Anesthesia Artline Packs Recalled for Potential Packaging Defects

    Medline Industries is recalling 120 Anesthesia Artline medical convenience kits due to BD ChloraPrep Triple Swabsticks with potentially open seals. Open packaging could compromise product sterility.

    Product
    Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2026·2026-02-18

    Medical device recall: Barco MNA adapter configuration manufacturing defect

    Steris Corporation is recalling 10 Barco MNA medical devices with HexaVue IP Integration System (Model MNA-6x0-H) due to an incorrect configuration file used during manufacturing of adapter components. Affected devices were distributed across seven U.S. states.

    Product
    Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2026·2026-02-18

    Leksell GammaPlan treatment planning software may target incorrect patient location

    Leksell GammaPlan version 11.1 software contains an error in stereotactic reference definition that may result in radiation treatment being planned for an incorrect patient location.

    Product
    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2026·2026-02-18

    ATEC Lateral Navigation Disc Prep Instruments recalled for connection geometry defect

    Alphatec Spine is recalling ATEC Lateral Navigation Disc Prep Instruments due to incorrect connection geometry in the navigated array. Seven units in Lot EM49968 are affected across multiple U.S. states.

    Product
    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1314-2026·2026-02-18

    Hologic Brevera Breast Biopsy Needle Recall: Particulate Contamination Risk

    Hologic is recalling over 681,000 Brevera Breast Biopsy System disposable 9 gauge needles due to potential particulate contamination that may deposit into breast tissue during use.

    Product
    Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2026·2026-02-18

    Medline Medical Kits Recalled Due to Potentially Open Applicator Packaging

    Medline Industries is recalling 21,854 units of sterile medical device kits containing ChloraPrep Triple Swabsticks due to potential open seals on applicator packaging. No illnesses have been reported.

    Product
    1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1331-2026·2026-02-18

    Medline Medical Convenience Kits Recalled for Unsealed Applicators

    Medline Industries recalls 7,380 medical convenience kits nationwide due to potentially open seals on BD ChloraPrep Triple Swabstick applicators, which could affect product sterility.

    Product
    Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1348-2026·2026-02-18

    Philips Azurion 7 M12 Imaging System Table Unexpected Movement Risk

    Philips has recalled the Azurion 7 M12 imaging system because the examination table may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is active. This could pose a patient safety risk.

    Product
    Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1349-2026·2026-02-18

    Philips Azurion 7 M20 System table moves unexpectedly despite active lock

    Philips is recalling the Azurion 7 M20 imaging system because the patient table may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. Approximately 5,136 units are affected worldwide.

    Product
    Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2026·2026-02-18

    Philips Azurion 7 B12 Medical System: Unexpected Table Movement Risk

    The Philips Azurion 7 B12 medical imaging system may experience unexpected table movement when the Reset Geometry button is pressed, even if the table lock is engaged. This could affect patient safety during medical procedures.

    Product
    Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1328-2026·2026-02-18

    Medline pediatric catheter securement kits recalled for potential open packaging seals

    Medline Industries is recalling 450 pediatric catheter securement dressing kits nationwide due to potential open seals on BD ChloraPrep applicator packaging. Open seals may compromise product sterility and integrity.

    Product
    Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2026·2026-02-18

    Azurion 5 M12 Imaging System Table May Move Unexpectedly During Operation

    Philips Azurion 5 M12 imaging system tables may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is active, posing a safety risk during medical procedures.

    Product
    Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1351-2026·2026-02-18

    Philips Azurion 5 M20 fluoroscopy table may move unexpectedly

    Philips is recalling 922 Azurion 5 M20 fluoroscopy systems because the patient table may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is active.

    Product
    Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1334-2026·2026-02-18

    Medline Medical Kits With BD ChloraPrep Swabsticks Recalled for Open Packaging Seals

    Medline Industries is recalling 8,445 medical convenience kits nationwide due to open seals on BD ChloraPrep Triple Swabstick applicator packaging. The defect may compromise product sterility.

    Product
    Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2026·2026-02-18

    Medical Imaging System Table May Move Unexpectedly During Reset

    Philips Azurion 3 M12 fluoroscopy systems may experience unexpected table movement when the Reset Geometry button is pressed, even when the table lock is active. The recall affects 291 units distributed worldwide.

    Product
    Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1347-2026·2026-02-18

    Medical imaging system recalled for unexpected table movement

    Philips Azurion 7 B20 fluoroscopy systems may move unexpectedly when the Reset Geometry button is pressed, even with the table lock engaged, creating a potential safety risk during medical procedures.

    Product
    Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1313-2026·2026-02-18

    Intubation Tray recalled for incorrect suction catheter size risk

    Medline Industries is recalling Intubation Trays (SKU DYNJAA245B) distributed nationwide and in Canada because smaller 8 Fr suction catheters were packed instead of required 14 Fr catheters, which may cause airway obstruction and respiratory failure.

    Product
    Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2026·2026-02-18

    Laerdal Compact Suction Unit 4 Recalled for Excessive Electromagnetic Emissions

    Laerdal Medical Corporation recalled certain Compact Suction Unit 4 RTCA models because units made during a limited period may emit electromagnetic noise exceeding established RTCA standards.

    Product
    Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2026·2026-02-18

    Medline Medical Kits Recalled Due to Potential Open Packaging Seals

    Medline Industries is recalling 216 medical convenience kits containing BD ChloraPrep Triple Swabsticks due to potential open seals on applicator packaging that may compromise product sterility.

    Product
    Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2026·2026-02-18

    Leksell GammaPlan radiation therapy planning software stereotactic reference error

    Leksell GammaPlan software versions 11.3 and 11.4 contain an error in stereotactic reference definition that may cause treatment plans to irradiate incorrect patient locations if the error goes undetected.

    Product
    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2026·2026-02-18

    Medline Catheter Securement Kits Recalled for Potentially Open Applicator Seals

    Medline Industries is recalling 1,350 Adult Cath Securement Dressing Kits with potentially open seals on BD ChloraPrep Triple Swabstick applicators. Open packaging may compromise product sterility.

    Product
    Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Kit SKU DYNDC3109
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1333-2026·2026-02-18

    Medline Blood Culture Kit Recall Due to Open Applicator Seal

    Medline Industries is recalling 4,300 Blood Culture Kits due to open seals on applicator packaging that could compromise sterility and introduce contamination during specimen collection.

    Product
    Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2026·2026-02-18

    Medline Circumcision Kit Applicators Recalled for Open Packaging Seals

    Medline is recalling specific circumcision kits due to potentially open seals on sterile applicators that could compromise sterility. This affects 168 units distributed nationwide.

    Product
    Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2026·2026-02-18

    Philips Spectral CT 7500 fastener torque specification recall

    Philips has recalled the Spectral CT 7500 medical imaging device due to fasteners that may not be torqued to specification, potentially allowing rotor parts to become unsecured or displaced. No injuries have been reported.

    Product
    Spectral CT 7500 on Rails; Product Code (REF): 728334;
    Category
    Medical Device
    Distribution
    Distributed nationwide