The Recall Desk

State

Delaware product recalls

72,913 recalls have nationwide distribution and so reach Delaware. 3,435 additional recalls listed Delaware specifically in their distribution scope.

What the numbers show

Total
3,435
Critical
477
Severe
937
Most recent
2026-09-09

Of the 3,435 recalls naming Delaware we have scored against our rubric, 477 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 937 (27%) are Severe.

Which agencies issued them

These figures cover only the 3,435 recalls whose distribution notice names Delaware specifically. The 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1901–1925 of 76348

  • SevereFDA (Drugs)·D-0513-2026·2026-05-13

    DELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues

    Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from bag perforations that could compromise sterility. Affected patients should contact their healthcare provider immediately.

    Product
    DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2026·2026-05-13

    LUX-Dx II Plus Arrythmia Detector Software Monitoring Feature Failure

    Boston Scientific's LUX-Dx II Plus implantable cardiac monitors may fail to collect PVC Burden data or monitor for abnormal heart rhythms in some upgraded devices, creating potential gaps in patient monitoring.

    Product
    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2096-2026·2026-05-13

    Medline Convenience Kits Recalled for Sterilization Equipment Calibration

    Medline is recalling certain Dental Pack and Surgical Pack convenience kits due to calibration issues with sterilization equipment that may affect sterility assurance. Approximately 3,508 units were distributed nationwide.

    Product
    Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2026·2026-05-13

    Medline Convenience Kits recalled for potential sterilization issue

    Medline Industries is recalling 26 models of medical convenience kits used in clinical settings because equipment calibration issues may have compromised sterility assurance during sterilization and packaging.

    Product
    Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487; 5) PEDS PICC INSERTION TRAY, Mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2026·2026-05-13

    Medline Basic Nerve Block Tray sterilization calibration issue

    Medline is recalling Basic Nerve Block Trays due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2110-2026·2026-05-13

    Medline Convenience Kits for C-Section and Obstetric Procedures

    Medline Industries is recalling 12,529 units of sterile surgical convenience kits used in cesarean section and obstetric procedures worldwide due to equipment calibration issues that may compromise sterilization assurance.

    Product
    Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2026·2026-05-13

    Medline Convenience Kits Recalled Over Sterilization Calibration Issues

    Medline is recalling three models of medical convenience kits (central line, LVAD driveline, and surgical oncology) distributed nationwide due to calibration issues in sterilization equipment that may have reduced sterility assurance.

    Product
    Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2026·2026-05-13

    BioCera Fibers Bioresorbable Bone Void Filler Recall

    Orthorebirth Co Ltd is recalling BioCera Fibers, a bioresorbable bone void filler, because the product falls outside standard specifications. The recall affects 1266 units distributed nationwide in California and Florida.

    Product
    BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2026·2026-05-13

    Medline Convenience Kits sterilization and packaging calibration issues recalled

    Medline Industries is recalling multiple Convenience Kit models used in cardiac, vascular, and surgical procedures due to calibration issues with sterilization and packaging equipment that could impact sterility assurance. Approximately 39,341 units distributed worldwide may be affected.

    Product
    Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0694-2026·2026-05-13

    Woodstock organic shelled edamame may contain metal pieces

    Woodstock Organic Shelled Edamame in 10 oz and 48 oz bags is being recalled because the product may contain metal pieces. 7,160 cases are affected.

    Product
    Woodstock Organic Shelled Edamame 10 oz. and 48 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2026·2026-05-13

    da Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage

    Intuitive Surgical is recalling certain Universal Surgical Manipulator arm sub-assemblies in da Vinci X and Xi Surgical Systems due to screws that may be susceptible to breaking during use.

    Product
    Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0512-2026·2026-05-13

    DELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk

    Fresenius Medical Care is recalling DELFLEX Dextrose Peritoneal Dialysis Solution bags due to potential leaks from perforations that may compromise sterility. The recall affects 37,215 bags distributed nationwide.

    Product
    DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2026·2026-05-13

    Medline Convenience Kits recalled for potential sterilization compromise

    Medline Industries is recalling eight models of Convenience Kits due to calibration issues with sterilization equipment that may have affected the sterility assurance level of the devices.

    Product
    Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2102-2026·2026-05-13

    Medline Convenience Kits Recalled Due to Sterilization Equipment Calibration Issues

    Medline Industries is recalling multiple Convenience Kits nationwide because sterilization equipment calibration issues may have compromised the sterility assurance level of the products, despite exposure to validated sterilization cycles.

    Product
    Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Mode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2125-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization equipment calibration issues

    Medline Industries is recalling three models of medical trays due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects LVAD Driveline Trays and Central Line Dressing Change Trays distributed nationwide.

    Product
    Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2067-2026·2026-05-13

    BioFire Joint Infection Panel diagnostic test kit contamination recall

    BioFire Diagnostics is recalling its Joint Infection (JI) Panel diagnostic test kits due to contamination that may produce false positive results.

    Product
    BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2026·2026-05-13

    BioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives

    BioFire Diagnostics, LLC is recalling the Spotfire Respiratory/Sore Throat Panel due to false negative test results and control failures that may not accurately detect infections.

    Product
    Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2026·2026-05-13

    Medline Cardiac Surgery Kits Recalled Due to Sterilization Equipment Calibration Issues

    Medline Industries is recalling cardiac surgery convenience kits because sterilization and packaging equipment calibration issues may have affected the sterility assurance level of the devices.

    Product
    See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2026·2026-05-13

    Medline Medical Device Convenience Kits Sterilization Calibration Recall

    Medline Industries is recalling multiple Convenience Kit medical devices due to calibration issues in sterilization and packaging equipment that may affect sterility assurance. The devices were distributed nationwide.

    Product
    See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326B; 4) DRAWER #5, Model Number: ACC010475; 5) DRAWER 1 NEURO CAR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26E030000·2026-05-13

    Hale Recalls Weldon UV800 Display Units for Emergency Equipment Failure

    Hale Products Inc is recalling Weldon UV800 Display Units that may fail to power on or respond to touch, preventing the activation of emergency lights and firefighting equipment.

    Product
    EQUIPMENT:EMERGENCY:FIRE SUPRESSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2026·2026-05-13

    Medline PPE Kit recalled for sterilization calibration issues

    Medline is recalling Convenience Kits (PPE Kit, Model DYK1011945P) due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. The product was distributed nationwide.

    Product
    Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2026·2026-05-13

    Medline Surgical Device Kits Recalled Due to Sterilization Equipment Calibration Issues

    Medline Industries is recalling approximately 15,806 surgical device kits used in gynecology, urology, and thoracic procedures. Calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.

    Product
    See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2026·2026-05-13

    ERBEFLO CleverCap Endoscope Tubing Sets Recalled for Water Aspiration Risk

    Erbe Medical is recalling ERBEFLO CleverCap hybrid tubing and cap sets for endoscopes due to a connector configuration that may allow unintended water flow, potentially leading to water aspiration and serious respiratory complications.

    Product
    ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2026·2026-05-13

    Prodisc C SK Cervical Implant Size Labeling Mix-Up Recall

    Centinel Spine is recalling Prodisc C SK U.S. cervical disc implants due to a labeling mix-up: 6mm products were labeled as 5mm and 5mm products were labeled as 6mm, creating risk of implanting the wrong size.

    Product
    Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2026·2026-05-13

    Physio-Control Defibrillators May Lack Required Performance Inspection

    Physio-Control defibrillators (LIFEPAK 15, 1000, 35, and 20e models) serviced between July 2023 and November 2025 may not have undergone required Performance Inspection Procedures, potentially preventing therapy delivery.

    Product
    LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-00193
    Category
    Medical Device
    Distribution
    Distributed nationwide