The Recall Desk

State

Delaware product recalls

20,083 recalls have nationwide distribution and so reach Delaware. 0 additional recalls listed Delaware specifically in their distribution scope.

About recalls in Delaware

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Delaware consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

6226–6250 of 20083

  • HighFDA (Devices)·Z-1013-2025·2025-01-29

    Wolf-Pak Dressing Change Kits Recalled Due to Package Defects

    Trinity Sterile is recalling Wolf-Pak Dressing Change Kits (lot #600018) due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.

    Product
    Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2025·2025-01-29

    Olympus Thunderbeat surgical instrument probe tips breaking and detaching

    Olympus is recalling Thunderbeat surgical instruments due to probe tip damage, breaking, and pad detachment.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000687 Software Version: N/A Product Description: Thunderbeat instrument is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2025·2025-01-29

    Olympus Thunderbeat Surgical Hand Instruments Recalled for Probe Damage

    Olympus Corporation is recalling Olympus Thunderbeat front-actuated surgical hand instruments (Model TB-0535FCS) due to damaged or breaking probe tips and pad detachment. Approximately 128,608 units distributed outside the US are affected.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423730 Software Version: N/A Product Description: Thunderbeat instrument is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2025·2025-01-29

    Medical Analyzer Software May Fail to Alert of Expired Reagent Packs

    The VITROS 5600 Integrated System's software (version 3.8.0 and higher) may fail to notify users when Signal Reagent Packs expire. This could result in use of expired reagents, causing no results or erroneous results from tests.

    Product
    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2025·2025-01-29

    HALYARD Laparotomy Surgical Pack Recalled for Additive Residue Contamination

    O&M HALYARD is recalling HALYARD Laparotomy Packs due to elevated residues of anti-block/slip additives found in the sterile packaging. These surgical instruments were distributed nationwide.

    Product
    Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0989-2025·2025-01-29

    CardioMEMS Heart Failure Monitoring System Cloud Migration Causes Inaccurate Pressure Readings

    St. Jude Medical recalled 431 CardioMEMS HF pressure measurement systems after a cloud data migration reverted systems to outdated configuration, causing inaccurate pulmonary artery pressure readings.

    Product
    CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0995-2025·2025-01-29

    Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips

    Olympus has recalled Thunderbeat surgical hand instruments because the probe tips can become damaged or broken, including pad damage and detachment. The recall affects 36,712 units distributed internationally outside the United States.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424030 Software Version: N/A Product Description: Thunderbeat instrument is a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2025·2025-01-29

    Dressing change kits recalled due to packaging defect compromising sterility

    Trinity Sterile is recalling Dressing Change Kits with ChloraPrep and HaloGUARD due to potential holes in the package that could compromise product sterility. The recall affects 1,980 units distributed across multiple states.

    Product
    Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2025·2025-01-29

    Otological Ventilation Tubes Recalled for Missing FDA 510(k) Clearance

    Adept Medical Ltd is recalling 13,070 Otological Ventilation Tubes because they were distributed without FDA 510(k) clearance. Over 9,000 units were distributed in the US and 3,980 internationally.

    Product
    Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2025·2025-01-29

    Baxter Solution Set with Duo-Vent Spike Recalled for Inverted Clamps

    Baxter Healthcare is recalling specific lots of its Solution Set with Duo-Vent Spike due to inverted side clamps that may render the tubing unusable. The affected product was distributed nationwide.

    Product
    Baxter Solution Set with Duo-Vent Spike, REF 2R8404
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2025·2025-01-29

    Dressing Change Kit Recalled Due to Package Integrity Concern

    Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.

    Product
    Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0981-2025·2025-01-29

    Stryker neurosurgical device labeling mismatch: wrong instruments shipped

    Stryker is recalling 3.0MM Neuro Match Head devices (REF 5820-107-430) where the actual device may not match the product label, potentially causing surgeons to use wrong instruments during neurosurgery.

    Product
    stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2025·2025-01-29

    Dressing Change Kits Recalled for Potential Package Sterility Compromise

    Trinity Sterile is recalling Wolf-Pak Dressing Change Kits due to a potential hole in the package that could compromise the sterility of the medical kit. Lot #600022 (3,960 units) distributed nationwide.

    Product
    Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Componen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2025·2025-01-29

    Stryker 3.0MM Neuro Precision Head Recalled for Package Labeling Mismatch

    Stryker is recalling the 3.0MM Precision Neuro Match Head due to a packaging discrepancy where the device may not match the product label. Approximately 1,489 units distributed worldwide are affected, including lot numbers 22179047, 22179027, and 22160017.

    Product
    stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1004-2025·2025-01-29

    BD PCR Cartridges for MAX System signal drift in select lots

    Specific lots of BD PCR Cartridges used with the MAX System may experience signal drift, potentially affecting diagnostic accuracy. BD has initiated a recall of 516,435 affected units worldwide.

    Product
    BD PCR Cartridges used with MAX System. Model Number: 437519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2025·2025-01-29

    Olympus Thunderbeat Surgical Instrument Recalled for Damaged or Breaking Probe Tips

    Olympus is recalling approximately 9,200 units of Thunderbeat surgical hand instruments distributed worldwide because probe tips can become damaged, break, or pads can detach during use.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2025·2025-01-29

    Olympus Thunderbeat Hand Instrument Probe Tips May Break or Detach

    Olympus is recalling the Thunderbeat surgical hand instrument because the probe tips are being damaged or breaking. The recall affects 34,325 units distributed in the US and internationally.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, sing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0999-2025·2025-01-29

    Olympus Thunderbeat Surgical Instrument Recalled for Damaged Probe Tips

    Olympus is recalling the Thunderbeat 5 mm surgical hand instrument due to damaged or broken probe tips and pads. The defect may affect surgical function and device performance.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423430 Software Version: N/A Product Description: Thunderbeat instrument is a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2025·2025-01-29

    Randox Lipoprotein (a) assay distributed without required FDA clearance

    Randox Lipoprotein (a) assay for Roche Cobas c501 analyzers was distributed without required FDA 510(k) or PMA regulatory clearance. The diagnostic test kits lack formal validation for their claimed measurements.

    Product
    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2025·2025-01-29

    Baxter Continu-Flo Solution Set with Duo-Vent Spike recalled for inverted clamps

    Baxter is recalling specific lots of Continu-Flo Solution Sets due to potentially inverted side clamps that render the tubing unusable. Distribution included eight US states.

    Product
    Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0997-2025·2025-01-29

    Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips

    Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423630 Software Version: N/A Product Description: Thunderbeat instrument is a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1001-2025·2025-01-29

    Olympus Thunderbeat Hand Instruments Recalled for Probe Tip Damage and Breaking

    Olympus is recalling Thunderbeat hand instruments because probe tips can be damaged or break, and pads can detach during use. No injuries have been reported.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0966-2025·2025-01-29

    Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance

    Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone) distributed without FDA 510(k) premarket notification clearance. Approximately 6,280 units were distributed in the US and internationally.

    Product
    Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1000-2025·2025-01-29

    Olympus Thunderbeat Surgical Instruments Recalled for Damaged Probe Tips

    Olympus Corporation is recalling Olympus Thunderbeat surgical hand instruments (Model TB-0545FCS) due to probe tips that are being damaged or breaking, which may affect instrument function during medical procedures.

    Product
    Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423510 Software Version: N/A Product Description: Thunderbeat instrument is a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0208-2025·2025-01-29

    Venlafaxine Extended-Release Tablets Recalled for Missing Tablet Identification

    Appco Pharma LLC is recalling Venlafaxine Extended-Release Tablets, 150mg, due to missing tablet identification imprints. The defect affects 1,380 bottles distributed nationwide.

    Product
    VENLAFAXINE — VENLAFAXINE (VENLAFAXINE)
    Category
    Drug
    Distribution
    Distributed nationwide