The Recall Desk

State

Delaware product recalls

72,992 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.

These figures cover only the 3,435 recalls whose distribution notice names Delaware specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8451–8475 of 76427

  • SevereFDA (Devices)·Z-0682-2025·2025-01-01

    Blood Glucose Ketone Meter Firmware Bug Causes Inaccurate Test Results

    Software bug in StatStrip Glucose Ketone Hospital Meter System can cause incorrect blood glucose and ketone test results to be transmitted to healthcare data systems. 347 units affected.

    Product
    StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0683-2025·2025-01-01

    Blood glucose ketone meter software bug causes erroneous result transmission

    Nova Biomedical's StatStrip glucose ketone hospital meter (Model 63910) has a software bug that may transmit erroneous results to healthcare systems. The issue affects 1,615 units distributed across the US and internationally.

    Product
    StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0681-2025·2025-01-01

    Glucose Hospital Meter Software Bug Transmits Inaccurate Results

    StatStrip Glucose Hospital Meter software bug may transmit erroneous glucose values to healthcare systems, potentially leading to incorrect patient treatment. 2,365 units affected nationwide and internationally.

    Product
    StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0757-2025·2025-01-01

    Sterile Magill Forceps Recalled Due to Weak Seals and Contamination Risk

    Medline has recalled Sterile Magill Forceps (Item No. 66790) due to weak seals that may compromise sterility. The defect affects approximately 21,440 units distributed nationwide.

    Product
    STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0726-2025·2025-01-01

    Surgical procedure kits recalled for elevated endotoxin levels

    Medline surgical kits containing sterile surgical patties and strips have been recalled due to higher-than-expected endotoxin levels in raw materials. The affected supplies may pose a risk during sterile surgical procedures.

    Product
    Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS, SKU CDS981753K; 5) LAMINECTOMY CDS-LF, SKU CDS981923X; 6)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2025·2025-01-01

    O&M Halyard Procedure Masks Recalled for Unmet Bioburden Testing Requirements

    O&M HALYARD is recalling O&M Halyard Procedure Masks (Product Code 47117) nationwide because they do not meet bioburden testing requirements printed on the packaging.

    Product
    O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2025·2025-01-01

    Abbott Vascular Inflation Device May Leak During Cardiovascular Procedures

    Abbott Vascular is recalling the 20/30 Priority Pack Accessory Kit w/Copilot inflation device used in cardiovascular procedures because it may leak at connection points, potentially causing air embolism.

    Product
    20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0749-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply Failure Risk

    BD is recalling FACSLyric flow cytometer power supplies that may fail to power on or stay on, creating risks of fume inhalation and requiring patients to return for repeat biospecimen collection procedures.

    Product
    FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0766-2025·2025-01-01

    EMPOWR 3D Knee Tibial Insert Package Mix-Up Causes Surgical Delays

    Encore Medical recalls EMPOWR 3D Knee Tibial Insert packages that may contain the wrong size implant (5R 16MM with 3R 14MM and vice versa), potentially delaying surgery. The recall affects 33 units nationwide.

    Product
    EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2025·2025-01-01

    Medline Surgical Patties and Strips Recalled for Endotoxin Contamination

    Medline recalls surgical patties and strips from specific kit lots due to higher-than-expected endotoxin levels. The 318 kits were distributed in the United States and Canada.

    Product
    Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2025·2025-01-01

    Siemens Blood Analysis Device Recalled Over Patient Name Mix-up Software Defect

    Siemens is recalling the epoc NXS blood analysis system due to a software flaw that can assign incorrect patient names to test results, risking misdiagnosis or mistreatment if the operator doesn't verify the patient name.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2025·2025-01-01

    Medline Surgical Scissors Recalled for Sterility Seal Defect

    Medline O.R. scissors may have weak seals that compromise sterility, increasing risk of contamination and infection. Approximately 21,440 units from lot 2023052490 have been recalled nationwide.

    Product
    O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0718-2025·2025-01-01

    Surgical patties and strips recalled due to endotoxin contamination

    Medline Industries is recalling FESS-MB PACK-LF Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification finished products.

    Product
    FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2025·2025-01-01

    FDA Recalls Medical Spine Component Due to Manufacturing Defects

    SEASPINE Orthopedics is recalling 191 Daytona Small Stature Ti Locking Caps due to manufacturing defects that prevent proper component mating.

    Product
    Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2025·2025-01-01

    Merlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing

    A software anomaly in Abbott's Merlin PCS 3650 programmer may prevent proper finalization of leadless pacemakers, causing loss of pacing function. The issue occurs when specific actions combine with brief telemetry loss.

    Product
    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply May Fail During Use

    BD FACSLyric flow cytometers are recalled for power supply failures that may prevent the device from powering on, risking specimen loss and potential respiratory effects from fume inhalation.

    Product
    Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0159-2025·2025-01-01

    Prescription chlorpromazine tablets recalled due to manufacturing quality defect

    Glenmark Pharmaceuticals is recalling chlorpromazine hydrochloride 10mg tablets nationwide due to manufacturing deviations that allowed excess N-nitroso impurity.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0165-2025·2025-01-01

    Duloxetine delayed-release capsules recalled due to manufacturing impurity

    Duloxetine delayed-release 60mg capsules are being recalled nationwide due to N-nitroso-duloxetine impurity above recommended interim limits. Two lot numbers are affected: J0786744-061724 (blister cards) and B3002625-060524 (bottles).

    Product
    Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0160-2025·2025-01-01

    Chlorpromazine Hydrochloride tablets recalled for manufacturing impurity excess

    Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride tablets due to manufacturing deviations that resulted in an impurity exceeding FDA limits. The affected lot (17230133, expiring 12/31/2024) was distributed nationwide.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0158-2025·2025-01-01

    Duloxetine Delayed-Release Capsules Recalled Nationwide for Excess N-Nitroso Impurity

    Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity above recommended limits. The affected product was distributed nationwide in 1,815 bottles with two specific lot numbers and expiration dates.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply Module Failure Risk

    BD is recalling power supply modules on FACSLyric flow cytometers that may fail to power on or stay on. Failure could cause lab staff to inhale fumes and patients to need repeat blood draws.

    Product
    FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath ta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0155-2025·2025-01-01

    Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity

    Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules 30 mg nationwide due to N-nitroso-duloxetine impurity above recommended limits. Patients should contact their healthcare provider.

    Product
    Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2025·2025-01-01

    Siemens magnesium reagent cartridges recalled for false measurement results

    Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.

    Product
    Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2025·2025-01-01

    Medline ST IUD Removal Hook Recalled Due to Weak Seals and Sterility Risk

    Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.

    Product
    ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0737-2025·2025-01-01

    Blood Analysis System Software Malfunction May Assign Incorrect Patient Names

    Siemens epoc NXS Host blood analysis systems contain a software malfunction that may assign incorrect patient names to blood measurements. This could result in clinicians making treatment decisions based on the wrong patient's test results.

    Product
    epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capi
    Category
    Medical Device
    Distribution
    Distributed nationwide