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.

9326–9350 of 76427

  • HighFDA (Devices)·Z-0163-2025·2024-10-30

    Medline Dialysis Pack Recalled Due to Potential Non-Sterile Product Risk

    Medline is recalling 90 units of its dialysis convenience kit due to potential non-sterile product if the package seal is compromised. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2025·2024-10-30

    Medline chest tube insertion tray may contain non-sterile equipment due to breached seal

    Medline is recalling certain chest tube insertion trays due to potential sterility loss if the vendor seal is breached. Non-sterile equipment poses a serious risk during invasive medical procedures.

    Product
    Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0223-2025·2024-10-30

    A1CNow+ Multi-Test HbA1c System recalled due to mismatched cartridge and analyzer codes

    Polymer Technology Systems recalled 2,452 A1CNow+ diabetes test systems due to mismatched cartridge and analyzer codes. Non-matching components may produce inaccurate blood glucose readings.

    Product
    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2025·2024-10-30

    Internal Defibrillation Paddles Recalled for Cracks and Separation

    Physio-Control is recalling sterilizable internal defibrillation paddles (LP20 and LP15 models) due to cracking and over-molding separation. The defects may prevent proper device function during critical cardiac emergency treatment.

    Product
    STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Sync
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0017-2025·2024-10-30

    Phenylephrine HCl Injectable Drug Recalled for Manufacturing Practice Violations

    Fresenius Kabi is recalling 1,378 bags of phenylephrine HCl injection due to manufacturing violations. The recall affects 125 healthcare facilities nationwide.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0154-2025·2024-10-30

    Medline Medical Procedure Convenience Kits Recalled for Potential Sterility Issue

    Medline is recalling 312 medical procedure convenience kits due to potential sterility issues if the breather pouch seal is opened or damaged. The affected kits were distributed in the US, Canada, and Panama.

    Product
    Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2025·2024-10-30

    Medline dental pack may contain non-sterile product due to packaging defect

    Medline dental procedure kits may contain non-sterile product if the breather pouch seal is compromised. The recall affects 165 units distributed in the US, Canada, and Panama.

    Product
    Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2025·2024-10-30

    Medline Centurion EP LAB INSTRUMENT KIT Recalled for Potential Sterility Compromise

    Medline Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.

    Product
    Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Sterility Compromise

    Medline is recalling specific medical procedure convenience kits because a packaging defect could allow non-sterile product to be used if the vendor seal is opened.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2025·2024-10-30

    Olympus Soltive Pro Laser Systems Recalled for Incorrect Bladder Stone Translation

    Olympus is recalling Soltive Pro SuperPulsed Laser Systems because the term 'Bladder Stone' was incorrectly translated as 'Kidney Stone' in Spanish and Portuguese, posing a risk of unintended energy delivery.

    Product
    Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2025·2024-10-30

    Boston Scientific myLUX Patient Application Recalled for Data Transmission Failure

    Boston Scientific is recalling the myLUX Patient Application for Apple mobile devices because it may fail to transmit cardiac monitor data to the LATITUDE Clarity website.

    Product
    Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2025·2024-10-30

    Medline IV TEAM PICC Kits Recalled Due to Potential Non-Sterile Product

    Medline IV TEAM PICC medical procedure kits may contain non-sterile product if the breather pouch vendor seal has been opened. The recall affects 120 units distributed worldwide including the US, Canada, and Panama.

    Product
    Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2025·2024-10-30

    Medline Pediatric Drape Kit Recalled Due to Potential Non-Sterile Product Risk

    Medline recalled pediatric drape kits that may become non-sterile if the pouch seal is compromised. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2025·2024-10-30

    Medline Medical Procedure Convenience Kits Recalled for Sterility Risk

    Medline is recalling specific medical procedure convenience kits because a packaging defect could allow the use of non-sterile products if the vendor seal is opened.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M; b) OB PACK, REF DYNJ17309G; c) OB PK, REF DYNJ34268D; d) OB DELIVERY PACK, REF DYNJ34274B; e) OB DELIVERY PACK, REF DYNJ34274B; f) D AND C PACK, REF DYNJ39668I; g) OB PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2025·2024-10-30

    Medline medical procedure kits recalled due to potential non-sterile packaging

    Medline is recalling 2,371 medical procedure convenience kits because certain kits packaged in specific breather pouches may contain non-sterile product if the seal is compromised.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2025·2024-10-30

    Medline Centurion Medical Procedure Kits Recalled for Sterility Risk

    Medline is recalling 168 Centurion medical procedure kits because packaging defects may allow non-sterile product use if the vendor seal is compromised.

    Product
    Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2025·2024-10-30

    Medline Medical Procedure Convenience Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling certain medical procedure convenience kits due to a breather pouch seal defect. If the pouch seal is opened or compromised, the product may not be sterile and could pose a health risk during surgical use.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2025·2024-10-30

    Medline medical procedure kits recalled for potential sterility breach

    Medline medical procedure convenience kits with certain breather pouches may lose sterility if the vendor seal is opened. Approximately 5,972 units were distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2025·2024-10-30

    Olympus Soltive Premium SuperPulsed Laser Recalled for Translation Labeling Error

    Olympus recalled 1,373 Soltive Premium SuperPulsed Lasers due to incorrect GUI translations of 'Bladder Stone' to 'Kidney Stone' in Spanish and Portuguese, potentially causing incorrect energy delivery to patients.

    Product
    Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling 88 convenience kits used in gynecological medical procedures due to potential non-sterility if the breather pouch seal is compromised. The affected lots are distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49302A; c) PERI GYN PACK, REF DYNJ57526A; d) HYSTEROSCOPY TRAY ACS, REF DYNJ68750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2025·2024-10-30

    AD-TECH Spencer Probe Depth Electrodes recalled for MRI safety labeling error

    Ad-Tech Medical Instrument Corporation is recalling 14 units of its AD-TECH Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The devices were labeled as MRI Conditional when they are actually MRI Unsafe, creating a risk of misuse.

    Product
    AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0225-2025·2024-10-30

    Endoscopic Dilation Balloon Mislabeled with Incorrect Size Information

    Olympus EZDilate Wire Guided Balloons with Lot 408987 have mislabeled sizing information. The device label states 11 mm, 12 mm, and 13 mm, but actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm, which may result in prolonged surgery.

    Product
    EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0079-2025·2024-10-30

    Amingo Anesthesia System: Risk of Breathing Circuit Misconnection to Auxiliary Outlet

    Datex-Ohmeda Amingo anesthesia systems may allow a patient breathing circuit to be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) instead of the proper outlet. The potential misconnection affects all 77 units worldwide.

    Product
    Amingo. OUS only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2025·2024-10-30

    Medline medical procedure kits recalled due to potential non-sterile packaging defect

    Medline brand medical procedure convenience kits packaged in breather pouch lot 323080002 may be non-sterile if the vendor seal is opened or compromised. Affected kits are distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0020-2025·2024-10-30

    FDA Recalls NORepinephrine Injection Due to Manufacturing Violations

    Fresenius Kabi Compounding is recalling NORepinephrine Bitartrate injection due to manufacturing violations. The affected medication was distributed to 125 accounts nationwide. Healthcare providers using this product should contact their supplier.

    Product
    NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
    Category
    Drug
    Distribution
    Distributed nationwide