The Recall Desk

State

Delaware product recalls

72,984 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 72,984 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7401–7425 of 76419

  • HighFDA (Devices)·Z-1334-2025·2025-03-26

    Medical Device Sterilization Assurance Recall: MAJOR DIEP Surgical Kits

    American Contract Systems Inc is recalling 17 MAJOR DIEP surgical kits because sterilization assurance requirements cannot be confirmed. This creates a risk of device malfunction and treatment delays.

    Product
    MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2025·2025-03-26

    Medline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk

    Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential packaging breach that could compromise sterility. The recall affects 16 units distributed nationwide.

    Product
    Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2025·2025-03-26

    Medline C-Section Procedure Kits Recalled for Defective Syringes

    Medline is recalling 456 C-section procedure kits containing plastic syringes affected by an FDA safety alert. The syringes may leak or break, posing a risk to patient health during surgical procedures.

    Product
    Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0277-2025·2025-03-26

    Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Safe Levels

    Rising Pharma is recalling Duloxetine Delayed-Release Capsules 30 mg (Lot DTB23111A) distributed nationwide due to N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This manufacturing impurity resulted from a CGMP deviation.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2025·2025-03-26

    Surgical Positioning Device Recalled for Unconfirmed Sterilization Assurance

    American Contract Systems Inc is recalling C-Section PPS positioning systems due to inability to confirm sterilization assurance requirements were met. The failure could lead to loss of functionality and delayed treatment.

    Product
    C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2025·2025-03-26

    Proxima Drape surgical drapes recalled due to potential sterility loss

    Medline Industries recalls 506 units of Proxima Drape surgical drapes nationwide due to potential packaging breaches that could compromise sterility. Affected drapes were labeled as MINOR PACK or LAPAROSCOPY variants.

    Product
    Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2025·2025-03-26

    General Angio Pack Sterilization Assurance Cannot Be Confirmed

    American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.

    Product
    GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2025·2025-03-26

    Birth Delivery Kit Recalled Due to Unconfirmed Sterilization Assurance

    American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.

    Product
    BORN ON ARRIVAL KIT , Model No LLBN11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V190000·2025-03-26

    Micro Bird Recalls G5 School Buses for Missing Seat Reinforcements

    Micro Bird is recalling certain G5 school buses because seat reinforcement supports may be missing, which could cause seats to detach in a crash.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0289-2025·2025-03-26

    FDA Recalls Subpotent CURAD Alcohol Prep Pads Nationwide

    Medline Industries is recalling CURAD Alcohol Prep Pads nationwide because they are subpotent. The recalled pads are sterile, medium, 2-ply alcohol prep pads distributed nationally.

    Product
    CURAD ALCOHOL PREP PADS — CURAD ALCOHOL PREP PADS (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2025·2025-03-26

    Medical Device Software May Merge Patient Records Without Notification

    Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.

    Product
    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1365-2025·2025-03-26

    Sterile Surgical Drape Recalled Due to Potential Packaging Breach

    Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.

    Product
    Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2025·2025-03-26

    CYSTO Model SACY80R Recall for Sterilization Assurance Failure

    American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.

    Product
    CYSTO , Model No SACY80R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0279-2025·2025-03-26

    Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity Above Safe Limits

    Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 60 mg for containing nitrosamine impurity above acceptable daily intake limits. The recall affects 2,444 bottles distributed nationwide.

    Product
    Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2025·2025-03-26

    Candida ID Antigen recalled for reduced sensitivity, potential false negatives

    Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.

    Product
    Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2025·2025-03-26

    Microstream Neonatal-Infant CO2 Filter Line May Be Difficult to Disconnect

    Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2025·2025-03-26

    DR DIULUS Injection Pack Models Recalled for Sterilization Assurance Issues

    American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.

    Product
    DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0286-2025·2025-03-26

    Injectable Drug Recalled for Stability Issues at Expiration

    Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.

    Product
    NEUPOGEN — NEUPOGEN (FILGRASTIM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0291-2025·2025-03-26

    FDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation

    Mylan Institutional is recalling 1,068 cartons of levothyroxine sodium 125 mcg tablets (Lot 3115773) distributed nationwide due to out-of-specification potency. The tablets contain higher-than-specified amounts, potentially resulting in excessive doses.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1364-2025·2025-03-26

    Surgical Drape Packs Recalled for Potential Sterility Breach in Packaging

    Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 units distributed nationwide.

    Product
    Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0287-2025·2025-03-26

    FDA Recalls Prasugrel Tablets for Failed Dissolution Specifications

    Golden State Medical Supply Inc. is recalling 2,601 bottles of Prasugrel 5 mg tablets due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting drug absorption.

    Product
    PRASUGREL — PRASUGREL (PRASUGREL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2025·2025-03-26

    Cystoscopy Kit Recalled for Sterilization Assurance Verification Failure

    American Contract Systems Inc is recalling CYSTO PACK cystoscopy kits because the company cannot confirm sterilization assurance requirements were met. Possible loss of functionality could delay or prolong patient treatment.

    Product
    CYSTO PACK , Model N. HKCY31A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0652-2025·2025-03-26

    Chef's Line 3 Grain Slider Buns Recalled for Foreign Material

    Chef's Line US Foods 3 Grain Slider buns are being recalled due to foreign material (a bolt) found in the product. Approximately 8,107 cases were distributed to IL, MD, NJ, PA, and DE.

    Product
    Chef's Line US Foods, 3 Grain Slider , 54/1.8 oz., Product in a plastic bag in a cardboard box. approx. 54 pieces per case. Keep Frozen,
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1388-2025·2025-03-26

    DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1356-2025·2025-03-26

    AV Fistula Kit Recall Due to Unconfirmed Sterilization Assurance

    American Contract Systems Inc is recalling 90 AV Fistula kits because sterilization assurance requirements cannot be confirmed. Possible loss of functionality could delay or prolong patient treatment.

    Product
    AV FISTULA , Model No UTAV77T
    Category
    Medical Device
    Distribution
    Distributed nationwide